Pfizer

Cardiovascular symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2020-12-31 hypertension I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Ligh... Read more
I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.
60 2021-01-01 chest pain Within 5 minutes of the vaccine, patient had wheezing, shortness of breath and chest pain. patient g... Read more
Within 5 minutes of the vaccine, patient had wheezing, shortness of breath and chest pain. patient given epi x 4, decadron, fluids with some improvement and then hospitalized. IN the hospital, patient continued to have chest pain and satting well but with protracted course and is still in the hospital.
60 2021-01-04 pallor Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her hist... Read more
Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.
60 2021-01-04 palpitations Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation... Read more
Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
60 2021-01-05 heart rate increased INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINES... Read more
INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.
60 2021-01-05 blood pressure increased dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to... Read more
dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
60 2021-01-05 hypertension hypertension, dizziness - occurred ~15 minutes after her first dose; first BP was 166/81, second dos... Read more
hypertension, dizziness - occurred ~15 minutes after her first dose; first BP was 166/81, second dose was 158/84; Taken to ED; outcome unknown
60 2021-01-06 fast heart rate 1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting. - 10:06... Read more
1/6/21 - 3pm. Experiencing chills, headache, heart rate at 103/min sitting. - 10:06 pm, chills, headache, fever 99.6 - 10:38 pm, chills headache, fever 100.1 - 11:05pm, chills headache, fever 101.5 -
60 2021-01-06 heart rate increased Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. wit... Read more
Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.
60 2021-01-07 chest pain Chest pain Abdominal pain Fever, severe chills, diaphoresis Seizure like activity for two night
60 2021-01-07 blood glucose increased Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD... Read more
Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.
60 2021-01-07 hypertension, heart rate increased When got shot my heart rate went up right away. Felt faint. Doctor took blood pressure and was ver... Read more
When got shot my heart rate went up right away. Felt faint. Doctor took blood pressure and was very high. Had me lay down and took blood pressure several more times until it went back down to normal. Took about 20 minutes.
60 2021-01-10 chest pain Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and ... Read more
Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021
60 2021-01-10 transient ischaemic attack Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and expe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and experienced a headache. The next day at 2:15pm the patient reported a temperature of 99.0 degrees Fahrenheit, not being as tired, but starting at 9:30 am that morning experiencing "tongue being tied" and having difficulty communicating described as "know what they want to say but it... doesn't come out" that lasted three hours. The patient denied problems walking or being confused. The patient was immediately referred to the emergency department for evaluation. Upon arrival to the emergency department patient had clear speech speaking in complete sentences and ambulating independently with a steady gait. Physical and neurological exams both normal: no aphasia and no focal neurological deficits, normal strength and sensation throughout. Initial vital signs within normal ranges except blood pressure 149/88 mmHg. Patient remained asymptomatic and stable throughout emergency department stay. Repeat vital signs were within normal ranges and patient was discharged to home with a diagnosis of transient ischemic attack. On follow-up visit with primary care physician four days after vaccination patient reports feeling much better and no new symptoms reported.
60 2021-01-10 chest pain She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion ... Read more
She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F
60 2021-01-11 blood pressure increased, heart rate increased Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inh... Read more
Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inhaler for 3-4 inhalations. Given Epinephrine, Benadryl, Solu-Medrol IM injections administered. 2L O2 via NC applied. Elevated BP and HR noted. Patient transported to ER. Duo-Neb nebulizer treatment provided. Bronchospasm and Wheezing subsided after approximately 45 minutes. Patient discharged hone with Prednisone and EPI pen prescriptions.
60 2021-01-11 heart rate irregular, cardiac arrhythmia, chest discomfort Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat an... Read more
Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest
60 2021-01-12 chest discomfort, oxygen saturation decreased, heart rate increased Approximately 5 minutes after receiving vaccine, patient started feeling chest tightness and increas... Read more
Approximately 5 minutes after receiving vaccine, patient started feeling chest tightness and increased heart rate and decreased oxygen. She was give 75 mg of Benadryl, and it did not help. 1 Epipen was administered and symptoms improved, but they began to return and a second epipen was administered approximately 30 minutes after the first epipen. EMS was already on site at that point and patient was taken in ambulance to hospital.
60 2021-01-13 palpitations Employee states she felt dizzy, lightheaded, palpitations and like her blood pressure was elevated.... Read more
Employee states she felt dizzy, lightheaded, palpitations and like her blood pressure was elevated. Vitals signs WNL, monitored for 60 minutes.
60 2021-01-13 fainting Systemic: Fainting-Medium; symptoms lasted 0 days
60 2021-01-14 chest pain 1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heavine... Read more
1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heaviness from belly button down to the legs. Advised to go to the EC for evaluation. Update 1/15: Seen in ED and had EKG with inverted T wave. Still has heaviness in legs. Will get a referral to cardiology after speaking with PCP.
60 2021-01-14 nosebleed None stop Nose bleed in right nostril
60 2021-01-14 palpitations reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports wea... Read more
reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports weakness,
60 2021-01-16 pallor, chest discomfort, fast heart rate Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: ... Read more
Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.
60 2021-01-17 lightheadedness limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her bo... Read more
limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;
60 2021-01-17 chest pain patient states that she had a reaction with the first vaccine but not until after she left the clini... Read more
patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.
60 2021-01-18 heart rate increased, palpitations Systemic: Fever-Medium, Systemic: rapid heartbeat-Medium
60 2021-01-19 heart rate increased Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS ... Read more
Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours
60 2021-01-19 heart rate increased Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart ra... Read more
Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.
60 2021-01-20 heart rate abnormal, atrial fibrillation, lightheadedness Episode of atrial fibrillation documented by my husband, a physician. He could not find a pulse aft... Read more
Episode of atrial fibrillation documented by my husband, a physician. He could not find a pulse after I had 2 near syncopal episodes. He listened to my chest and heard the abnormal rhythm . By the time I arrived at the ER, I had converted into normal sinus rhythm. We are both physicians. I am currently being evaluated by my PCP.
60 2021-01-20 palpitations Heart palpatations, fatigue, light hededness
60 2021-01-20 pallor, chest discomfort Received vaccine at 1:10pm. At 1:30pm, while in observation lot,patient complained of chest pressur... Read more
Received vaccine at 1:10pm. At 1:30pm, while in observation lot,patient complained of chest pressure 8/10 and appeared ashen and diaphoretic. Paramedics from the vaccine facility immediately responded to the patient. Patient stated these were the same symptoms she has had in the past when she has an allergic reaction, and stated she has reactions to 10 different "things". Patient carried an epi pen but stated she usually went to the ER and was treated there. On-site paramedics gave 0.5 mg IM to Left deltoid. Patient stated chest pressure went down to a 3/10, and she felt better. Ambulance arrived and patient was transported to Hospital.
60 2021-01-21 hypotension, fainting Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complet... Read more
Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complete lapse in memory of event I talked to a person just the day before. (Never happened before) Today, 1/22/21 I was sitting at my desk talking to another person and fainted for no reason. (Never happened before). I came to and after short while felt better.. Left work to rest at home. Have not seen a doctor yet but worried about 2nd vaccine dose. The syncope episode concerns me.
60 2021-01-21 pallor Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her r... Read more
Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her right hand was pale. + tingling. Brought to be evaluated by EMT.
60 2021-01-24 palpitations, hypertension I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the ... Read more
I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the male nurse that was present and he said that had Epinephrine, I had benadryl and he said that I could take one. Half an hour later my rash got worse and I took 20 mg prednisone that I had for my asthma. During the next two days I have had palpitations, fatigue and tiredness. Today my blood pressure was high and I have never had it like that before.
60 2021-01-24 blood pressure increased Swollen lip within minutes of 2nd Covid 19 vaccination. Blood pressure elevated at 206/110, heart r... Read more
Swollen lip within minutes of 2nd Covid 19 vaccination. Blood pressure elevated at 206/110, heart rate 97, pulse 97.8. Gave patient 50mg of oral diphenhydramine and monitored vitals and symptoms post dose for approximately 1 hour and 45 minutes. 1/2 hour post vaccination dose BP=180/100. At 1 hour post injection BP was returning to patients normal BP 164.98, pulse 81, Lip swelling is reducing. Also took patients blood sugar to check 1 hour post vaccination , it was 120.
60 2021-01-24 oxygen saturation decreased, heart rate increased, chest discomfort Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate... Read more
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-01-25 chest pain Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestio... Read more
Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.
60 2021-01-25 chest pain Fever 103.5, shaking chills, headache, pain in chest on inspiration
60 2021-01-25 chest pain Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizz... Read more
Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.
60 2021-01-25 chest discomfort, hypertension Pfizer-BioNTech COVID- 19 Vaccine EUA Symptoms included exacerbated blood pressure of 200/90, chest... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Symptoms included exacerbated blood pressure of 200/90, chest tightness, itching throat, and headache,
60 2021-01-25 fainting Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/... Read more
Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/92
60 2021-01-25 hypertension, blood pressure decreased, fainting The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, s... Read more
The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, she felt dizziness, her head was spinning, weakness of the arms, and slurred speech. Her FS was at 108 (Normal), BP 195/105 (Extremely high), Pulse 91, O2 saturation was at 100%. At 2:48PM, her BP lowered to 167/92. At this time, she can smile, she can put her hands up, she can kick her feet and she can opened/closed her eyes. Due to her high BP, Doctor requested that the should go to the ER via the ambulance.
60 2021-01-26 chest discomfort, heart rate irregular, chest pain Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that c... Read more
Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.
60 2021-01-26 blood clot First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and ... Read more
First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.
60 2021-01-26 chest pain allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath... Read more
allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it. Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown. Information on the lot/batch number has been requested.
60 2021-01-28 chest discomfort After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me an... Read more
After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me antibiotics. They also gave me an inhaler for my wheezing. I also felt a tightness sensation in my chest and lungs from all the coughing.
60 2021-01-28 chest discomfort nasal congestion. chest congestion. chest discomfort. Has been persistent to today 1/29/21.
60 2021-01-30 chest discomfort Wheezing, shortness of breath, felt like someone was sitting on my chest. Was given a burst of 40mg ... Read more
Wheezing, shortness of breath, felt like someone was sitting on my chest. Was given a burst of 40mg of Prednisone for 3 days and Nebulizer treatments 4 x a day. The Prednisone and nebulizer treatments helped.
60 2021-01-31 nosebleed nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tir... Read more
nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.
60 2021-02-01 palpitations pt stated about 2 hours after receiving her covid vax that her heart was racing, beating harder than... Read more
pt stated about 2 hours after receiving her covid vax that her heart was racing, beating harder than normal but subsided after about 2 hours. She was about to go to the ER but waited a little longer since she thought she was just having anxiety issues and did not have to go. She will contact her PCP today to let them know and discuss getting the second dose.
60 2021-02-03 atrial fibrillation Episode of atrial fibrillation; This is a spontaneous report from a contactable physician (patient).... Read more
Episode of atrial fibrillation; This is a spontaneous report from a contactable physician (patient). A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176), via an unspecified route of administration at Left arm on 13Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included scoliosis and depression. Concomitant medications in two weeks included duloxetine hydrochloride (CYMBALTA), estradiol/norethisterone acetate (COMBIPATCH). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EH9899) received on 20Dec2020 05:00 PM at left arm for COVID-19 immunization. The patient previously took codeine and experienced drug allergies. The patient experienced episode of atrial fibrillation on 17Jan2021 at 05:45 AM. No treatment received, no COVID prior vaccination. The outcome of the event was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event episode of atrial fibrillation and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-02-03 heart rate increased Rigors that lasted about 10 minutes at around 45 mins to 1 hour post vaccine. Elevated heart rate.
60 2021-02-03 chest discomfort, palpitations minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reporte... Read more
minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reported to job 1/15. She had hard time to ambulate wearing a facemask. 1/17 sx fully resolved.
60 2021-02-04 low blood platelet count, platelet count decreased admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a co... Read more
admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) via Intramuscular on 18Jan2021 into left arm at a single dose for covid-19 immunization. Medical history included hypothyroidism and neomycin allergies. The patient did not get covid prior vaccination. Concomitant medications included calcium, levothyroxine sodium (SYNTHROID), trazodone, tocopherol (VIT E) and no other vaccine in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via Intramuscular on 28Dec2020 into left arm at a single dose for covid-19 immunization. 24 hours after injection she developed petechiae and was admitted to hospital with platelet count of 8,000 on 20Jan2021 22:00, the patient has ITP with baseline platelet count of 60,000. All events lead to hospitalization for 5 days (PENDING CLARIFICATION) and received IgG and oral Dexamethas as treatment. On 20Jan2021, the patient did Sars Co V 2 RNA test via Nasal Swab and result negative. The outcome of the events was recovering.; Sender's Comments: Based on a close chronological association, a causal relationship between events petechiae and thrombocytopenia and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-02-06 heart rate increased High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking ... Read more
High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.
60 2021-02-06 heart rate increased Swelling of face & throat; rapid heart beat Hospital I received, a steroid shot & Hydroxyzine pill a... Read more
Swelling of face & throat; rapid heart beat Hospital I received, a steroid shot & Hydroxyzine pill and Rex?s + contact regular doc 3 Rx-1) 40 mg Prednisone for 4 days 2) Hydroxyzine 25mg as needed 3) Epi pen RETURNED TO ER 2/5/21 same symptoms after taking prednisone; told to take Hydroxyzine even though I have no rash & rare itchiness. ON GOING SYMPTOMS; UNRESOLVED
60 2021-02-07 fainting, chest pain, chest discomfort 12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down,... Read more
12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down, episode of syncope. Chest discomfort. ER for observation
60 2021-02-08 pallor The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and g... Read more
The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED
60 2021-02-08 low platelet count Thrombocytopenia. Bone marrow biopsy on 2/1/2021 showed severe peripheral pancytopenia and acellular... Read more
Thrombocytopenia. Bone marrow biopsy on 2/1/2021 showed severe peripheral pancytopenia and acellular marrow space, consistent with aplastic anemia. Patient has received dexamethasone, platelets, and PRBC. Unknown outcome patient has been discharged from the hospital.
60 2021-02-09 fast heart rate Pt reported tachycardia post receiving vaccination. Pt reported PMHX of anxiety. Symptoms response... Read more
Pt reported tachycardia post receiving vaccination. Pt reported PMHX of anxiety. Symptoms response within 5 minutes. No Treatment or Transport.
60 2021-02-10 chest discomfort Tightness in chest, throat swelling, tongue tingling. Lasted about 45 minutes. Did NOT use epipen. W... Read more
Tightness in chest, throat swelling, tongue tingling. Lasted about 45 minutes. Did NOT use epipen. Went to ER on site, received saline IV, was thoroughly checked and monitored, stayed 2 hours.
60 2021-02-10 blood pressure increased pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightl... Read more
pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightly elevated. Pt admitted to stress. Monitored for additional 30 min. Pt felt ok to go.
60 2021-02-14 chest discomfort 2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYE... Read more
2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.
60 2021-02-14 palpitations About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vacc... Read more
About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vaccine - a rash that itched. It lasted about 4 or 5 hours - I put Calamine lotion on it and that soothed it. I also experienced a little itching of eyes and a slight itching in mouth. About 9:30 pm I had a rapid heartbeat for about 30 or 40 minutes. The itching sensation continued off and on the next day but bumps weren't visible any longer. The itchy eyes continued off and on for the next day as well.
60 2021-02-14 heart rate increased, chest discomfort, chest pain Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbea... Read more
Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.
60 2021-02-14 heart rate increased, hypotension shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakn... Read more
shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.
60 2021-02-15 lightheadedness, heart rate increased 12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minu... Read more
12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.
60 2021-02-15 palpitations Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started ... Read more
Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started coughing, lost my voice, Itchy eyelids, my chest was pounding, and overall just did not feel right. EMS Took my blood pressure and it was 255, then they waited a smidge and decided to give me an injection of Benadryl, within 10 minutes of the Benadryl my blood pressure went down to 225, and I overall felt a little bit better. My eyelids were still swollen and itchy and I didn?t have a voice, they took my blood pressure again and it went down to 218. They stayed with me. I was starting to feel a little bit better. My blood pressure went down to 180 and there?s no wheezing in my chest. They let me leave shortly after that. I still do not have a voice. My eyelids are still swollen slightly and very itchy and my lips tingle.
60 2021-02-17 lightheadedness This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female pat... Read more
This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation . Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before). Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation. Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00 temperature of 100.6, arthralgias and myalgias, dizziness. Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness, Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias was recovering.
60 2021-02-17 lightheadedness lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded... Read more
lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
60 2021-02-21 palpitations During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations... Read more
During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.
60 2021-02-22 pallor Round rash the size of a 50 cents coin. Itchy and red. The area turns white when I lift my arm.
60 2021-02-22 palpitations Within a few seconds of receiving vaccine I experienced rapid heart beat/palpitations. This lasted f... Read more
Within a few seconds of receiving vaccine I experienced rapid heart beat/palpitations. This lasted for about 15 minutes then subsided.
60 2021-02-22 chest pain, troponin increased presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to i... Read more
presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to initially be systemic SEs from the vaccine but found to have re-collapse of the BI on chest CT with probable post obstructive pneumonia. still admitted as of 2/23/2021
60 2021-02-24 chest pain 10 min. After shot developed rash to chest, torso. On 4th day developed SOB, chest pain and fatigue.
60 2021-02-25 hypertension About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed... Read more
About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed. BP was high but otherwise vital signs within normal limits. Symptoms resolved.
60 2021-02-25 blood glucose increased, cardiac arrhythmia, chest pain, palpitations Sunday after administration, pt stated she started to feel her hear racing when going to bed, woke... Read more
Sunday after administration, pt stated she started to feel her hear racing when going to bed, woke up with her heart racing in the am. Pt stated to experience tingling and burning in her feet that later traveled to her hands. Pt has a history of PVCs but noted an increase in the PVC frequency. Chest pain that was intermittent but lasted for 4-5 days. Continues to experience twitches and tingling feet to this day.
60 2021-02-26 chest discomfort Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2... Read more
Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2 97% on intial check. She also reported a right frontal headache 5/10. Moved to cot to lie down, VS re-checked. Dizziness did not resolve with lying down. BP remained elevated as well. Once lying down, patient also reported "heaviness" in chest. A nurse remained with patient throughout entire incident and VS assessed frequently. After about 45 minutes, patient still reported HA, dizziness. Patient reported chest heaviness had resolved, but BP and dizziness did not resolve. Discussed calling EMS with patient, she agreed to allow us to call EMS. She was transported to local hospital by EMS at approximately 11:30am.
60 2021-02-28 fainting Fainting Extreme muscle aches
60 2021-02-28 blood glucose increased started to feel dizzy after getting the first dose of the COVID-19 Vaccine today; just checked her b... Read more
started to feel dizzy after getting the first dose of the COVID-19 Vaccine today; just checked her blood sugar, and her blood sugar was high at 146.; This is a spontaneous report from a contactable consumer (patient's daughter). A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the right arm on 28Jan2021at 09:30 (at the age of 60-years-old) as a SINGLE DOSE for covid-19 immunisation . Medical history included breast cancer female from 17Feb2019 (taking medicine for the breast cancer for 2 years), Cardiac disorder from an unknown date (problems with her heart about 2 weeks ago, and had to have her heart examined), and Prediabetes Concomitant medication(s) include takes medication for breast cancer and prediabetes. No other vaccines were given within 4 weeks No Additional Vaccines were administered on Same Date of the Pfizer Suspect. On 28Jan2021, The patient experienced started to feel dizzy after getting the first dose of the COVID-19 Vaccine today and just checked her blood sugar, and her blood sugar was high at 146. No Physician office visit and No Emergency room visit required due to the events. Reporter stated her mother is feeling better now. Patient checked her blood pressure and it was 127/72. The patient underwent lab tests and procedures which included blood glucose: High 146 on 28Jan2021; blood pressure measurement: 127/72 on 28Jan2021, cardiac stress test: unknown results on an unknown date, heart resistance test: unknown result on an unknown date. Caller asked what Pfizer recommends for the dizziness. The clinical outcome of the event dizzy was recovering which blood glucose high was unknown Information on the lot number has been requested.
60 2021-03-01 chest discomfort 5 Min after vaccine, pt. reported sharp poking sensation in left chest; heart palpitations. History ... Read more
5 Min after vaccine, pt. reported sharp poking sensation in left chest; heart palpitations. History of heart palpitations.
60 2021-03-01 blood glucose increased Being a diabetic, my blood sugar was in the 300's, and even after changing my insulin pump because I... Read more
Being a diabetic, my blood sugar was in the 300's, and even after changing my insulin pump because I believed there may have been an issue with delivery, my blood sugar continued to rise. I did not eat anything until about 6 PM when my blood sugar began to lower. At that time, I tried to eat some chicken soup, but after a few mouthfuls, my throat began to constrict and my tongue and the inside of my mouth began to itch. This continued every time I began to try to eat something and I still could feel what felt like some constriction in the back of my throat the next day (Monday).
60 2021-03-01 inflammation of the heart muscle, heart attack Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't c... Read more
Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization. The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.
60 2021-03-01 blood glucose increased Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had pa... Read more
Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days
60 2021-03-01 heart rate increased SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEA... Read more
SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEAT. DIZZINESS FOR APPROX 4 DAYS, HEADACHE FOR APPROX 4 DAYS
60 2021-03-02 blood pressure increased Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appet... Read more
Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.
60 2021-03-02 blood pressure increased Patient felt like she needed to cough, dry throat. Iniital BP 151/83. Final BP 137/88 (pulse 71). Gi... Read more
Patient felt like she needed to cough, dry throat. Iniital BP 151/83. Final BP 137/88 (pulse 71). Given water.
60 2021-03-02 cerebrovascular accident stroke occurred five days after receiving vaccine. I was hospitalized overnight in General Hospital... Read more
stroke occurred five days after receiving vaccine. I was hospitalized overnight in General Hospital. Have had two MRI's.
60 2021-03-04 fainting COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient dev... Read more
COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD
60 2021-03-04 fast heart rate First CPVOD Pfizer on 1/22/2021, 2nd COVID Pfizer on 2/19/2021 Developed episodes of tachycardia sta... Read more
First CPVOD Pfizer on 1/22/2021, 2nd COVID Pfizer on 2/19/2021 Developed episodes of tachycardia starting 2/12/21. Seen by me (MD) 2/15. BW showed low TSH, otherwise NL. Labs repeated and TSH undetectible with high Total T3 and NL Free T$. TSH stimulating AB very high, suggesting new Graves disease/Hyperthyroidism. We have a NORMAL TSH on file from March 2020
60 2021-03-04 chest discomfort Pt in 30 min waiting area. At 10:36 am reported tongue feeling funny. Upon assessment tongue was t... Read more
Pt in 30 min waiting area. At 10:36 am reported tongue feeling funny. Upon assessment tongue was thick , interfering with speech. BP: 186/93, Heart Rate : 66, Oxygen Saturation 99%, Temperature 97.6 F. Epinephrine 0.3 mL administered on left thigh at 10:42 am and 911 called. Pt reported inability to swallow and chest tightening at 10:51 am. Ambulance arrived.
60 2021-03-04 loss of consciousness Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to ... Read more
Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to her, she appeared to be sleeping. She did wake after physical stimulus but was lethargic, confused & stated she "felt dizzy"
60 2021-03-04 chest discomfort Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my is... Read more
Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my issue. If symptoms worsen I will go to ER
60 2021-03-07 heart rate increased Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme... Read more
Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
60 2021-03-07 fainting Fever greater than 104° for 24 hours. Syncope for 24 hours following that.
60 2021-03-07 chest discomfort, heart rate increased I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and ... Read more
I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.
60 2021-03-07 palpitations Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she... Read more
Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she was unable to swallow while driving home. Used rescue inhaler when she reached home for relief. Symptoms now resolved. H/O asthma
60 2021-03-07 chest discomfort On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My thr... Read more
On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.
60 2021-03-07 blood glucose increased Since the week after the first Pfizer vaccine, I began struggling with symptoms of diabetes. I exper... Read more
Since the week after the first Pfizer vaccine, I began struggling with symptoms of diabetes. I experienced extreme thirst, frequent urination and I lost 17 pounds in the 3 weeks following the first dose. I never associated it with the vaccine, initially, because I never heard of any side effects like increased glucose, and my dad and sister have type 2 diabetes, so I was altering my diet, but the symptoms did not subside. I proceeded to get the second vaccine and that?s when I knew something was seriously wrong. That afternoon my blood sugar was 528, my vision was blurred, and I experienced a strange feeling in my heart. I was diagnosed by my GP with diabetes, and put on medication (Metformin and Glipizide). I proceeded to see an endocrinologist, I was put on insulin and after additional blood tests was diagnosed with Latent Autoimmune Diabetes , and Premature Atrial Complexes.
60 2021-03-07 chest discomfort Throat tight, tongue feels numb, chest pressure. Evaluated by EMS- Transported to Emergency room/dep... Read more
Throat tight, tongue feels numb, chest pressure. Evaluated by EMS- Transported to Emergency room/department or urgent care.
60 2021-03-08 hypertension High Blood Pressure now am on medication and I have never had High blood pressure nor have I been on... Read more
High Blood Pressure now am on medication and I have never had High blood pressure nor have I been on BP medication. I have been taking medication for 2 weeks and my BP has maintained high
60 2021-03-08 vaginal haemorrhage Sore nipples and armpits for several days then today light vaginal bleeding I am in or done with me... Read more
Sore nipples and armpits for several days then today light vaginal bleeding I am in or done with menopause and have not had a period for several years
60 2021-03-08 fainting Syncope, difficulty focusing- Evaluated by EMS-Transported to Emergency room/department or urgent ca... Read more
Syncope, difficulty focusing- Evaluated by EMS-Transported to Emergency room/department or urgent care.
60 2021-03-08 chest pain, palpitations, chest discomfort difficulty breathing, chest tightness, pain palpitation (chest). Evaluated by EMS-Cleared
60 2021-03-08 chest discomfort, heart rate increased throat tightness, elevated HR, difficulty swallowing, chest pressure. Evaluated by EMS-Cleared
60 2021-03-09 blood glucose increased, chest discomfort acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse ... Read more
acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse voice, presyncope but epipen administered on site of vaccination location to avert syncope or cardiovascular collapse promptly. Symtoms occurred within 10 minutes of vaccine administration . Vaccine given 12:18 pm or 12:25 pm and symptoms within 10 minutes since in ER 12:30 pm but had received epipen en route before ER arrival since medical building was next to ER
60 2021-03-09 palpitations within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my b... Read more
within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.
60 2021-03-10 palpitations heart racing, anxious. Evaluated by EMS-Cleared
60 2021-03-11 chest discomfort 1538 Patient received vaccine and felt neck swelling and chest tightness.
60 2021-03-15 blood pressure decreased Approximately 5 minutes post injection my blood pressure plummeted and I began to feel faint. I also... Read more
Approximately 5 minutes post injection my blood pressure plummeted and I began to feel faint. I also started shaking uncontrollably particularly hands and arms. Vaccine administrator was immediately notified and they summoned the closest EMT. Emergency Services took my BO and pulse oximeter. A few minutes after the start of the symptoms. They explained that since my HR was at 84, BP was 110/68 and oxygen saturation was at 98% and I wasn't having difficulty breathing that I was not having an allergic reaction to the vaccine but a parasympathetic response instead. They sat with me until the shaking stopped approximately 15minutes later.
60 2021-03-15 chest discomfort Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt t... Read more
Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.
60 2021-03-15 blood pressure increased experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and bo... Read more
experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s
60 2021-03-16 chest discomfort A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back ar... Read more
A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back area which persisted to a heaviness in my chest going into Thursday. Thursday night I woke up in the middle of the night to the feeling of not being able to breathe. I laid awake for a while but dosed back off and it happened again a little later. It felt as if someone was sitting on my chest which prompted me to go to the ER the next day. Various test were done and I was admitted in the hospital for further observation. After admission I developed a massive headache which lasted from that Friday afternoon until that Sunday. I was released on that Sat and the symptoms seemed to be getting better and by that Sunday evening all symptoms had subsided.
60 2021-03-16 nosebleed After 2nd dose vaccine on 2/14/21 of Pfizer, got a very bloody nose beginning 2 days later and conti... Read more
After 2nd dose vaccine on 2/14/21 of Pfizer, got a very bloody nose beginning 2 days later and continuing 3 days later. Nose blood dried up but was very irritated for a total of 5 days
60 2021-03-16 heart rate irregular, blood glucose increased High blood sugar Irregular heart beat
60 2021-03-16 fainting, blood pressure increased Hot Flash with Sweats, Followed by fainting, Non-responsive, Elevated blood pressure
60 2021-03-17 heart rate increased, hypertension I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the ... Read more
I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the shot. I started having what looked like bruising all along the veins in my arms and hands. Still have that. I went to the doctor and also found that I had high blood pressure and an elevated heart rate. BP 140/90 and Heart rate 85. My normal heart rate is between 55-60 and my usual blood pressure is 108/70. The doctor gave me a steroid shot. This morning, my blood pressure and heart rate were still high and I still had a headache. Then the headache stopped and I took my blood pressure and it was down to around my usual 108/70 and the heart rate was 60. So hopefully I'm starting to recover from this shot.
60 2021-03-17 blood pressure increased, heart rate irregular Irregular heart beat that lasted about 14 hours....elevated blood pressure that reached 181/108...to... Read more
Irregular heart beat that lasted about 14 hours....elevated blood pressure that reached 181/108...took my Amlodipine when I got home and then the blood pressure fell to 110/74...after a couple hours the pressure returned to normal 123/75. Did not go to hospital..kept thinking it would go away and after many hours it did.
60 2021-03-17 loss of consciousness The day after her vaccine patient went to the bathroom and passed out. EMS came, but she started to ... Read more
The day after her vaccine patient went to the bathroom and passed out. EMS came, but she started to feel better and did not go to the hospital.
60 2021-03-17 cardiac arrest This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was s... Read more
This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am
60 2021-03-18 blood pressure increased Client c/o light headed feeling immediately after receiving vaccine. Client denies any other sympto... Read more
Client c/o light headed feeling immediately after receiving vaccine. Client denies any other symptoms. Client seen and assessed by EMT and assessments are: BP 173/78, HR 94, O2 96%, Client verbalized a decrease in symptom and cleared to go home by EMT. Client advised to seek medical attention if symptoms worsened and she verbalized understanding.
60 2021-03-18 arrhythmia Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pa... Read more
Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-03-18 heart rate increased Fast resting heart rate (>100 bpm), chills, difficulty/pain taking deep breath, dizziness
60 2021-03-18 palpitations Heart palpitations, anxiety,(felt this prior to today). 126/84, 87, 6, 99%, BGL 176
60 2021-03-19 chest pain, loss of consciousness 3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went t... Read more
3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went to bed about 10:30. Got up about 4:30 am to use bathroom, felt lightheaded and blacked out and apparently hit my head on something. Realized ears were closing up and had soreness in chest that made deep breath's difficult. Called 911 and nursing line and decided to go to Emergency Dept. Did CT scan for bumps on head and IV and gave me epinephrine and Pepcid. Was discharged with prescription for Epi Pen, Zyrtec, and Pepcid. Still have rash and hives but not as extensive, comes and goes.
60 2021-03-19 fainting Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal... Read more
Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal pain, nausea, vomiting and diarrhea resulting in 2 syncopal episodes. CBC showed leukocytosis with neutrophilia which resolved. She was treated with IV fluids and antiemetics and was discharged on 3/19/2021
60 2021-03-20 blood glucose increased COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 p... Read more
COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.
60 2021-03-21 nosebleed 3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NE... Read more
3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NECK; SHE CALLED HER PCP WHO HAD HER SUE HER EPI PEN - THE SWELLING RESOLVED. ON 3-20-21 SHE ALSO HAD A EARACHE, HEADACHE AND BLOODY NOSE. HAS TAKEN TYLENOL.'
60 2021-03-21 chest discomfort, palpitations, heart rate increased 8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscl... Read more
8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.
60 2021-03-22 chest discomfort, hypertension At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fing... Read more
At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.
60 2021-03-22 chest pain I could actually feel the vaccine entering my blood stream above and below injection area. I had sh... Read more
I could actually feel the vaccine entering my blood stream above and below injection area. I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness. Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.
60 2021-03-22 chest discomfort Shortness of breath, dizziness, chest pressure, started about 5 minutes after administration of vacc... Read more
Shortness of breath, dizziness, chest pressure, started about 5 minutes after administration of vaccine.
60 2021-03-23 palpitations As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vacc... Read more
As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vaccine admin. Was discharged from ER, but returned later for general weakness/lightheaded, heart racing, felt throat was closing.
60 2021-03-23 chest pain Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advi... Read more
Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advise I will not be coming in. I went back to bed no food no medicine, Most information I read and was aware is that it would be better with sleep. Only to wake up at 8:30pm with a 102.7 had 500 mg acetaminophen went back to bed. Woke up Thursday morning at 9:45am fever free. Friday afternoon I noticed swelling on my left neck area. Just inside my left clavicle. I made a Dr appointment for Monday and Dr. found several Lymph nodes swollen as well as under my left arm pit area. Due to some chest pain she sent me for a chest x-ray.
60 2021-03-23 heart rate irregular I was submitting my events daily on website and two days it tells me my session has expired and won'... Read more
I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.
60 2021-03-23 heart rate increased Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complainin... Read more
Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complaining of tingling in tongue/lips. Patient was evaluated and given diphenhydramine and famotidine. Symptoms were improved and patient was discharged. Patient returned to emergency department approximately 4 hours later with general weakness/lightheadedness, rapid heartbeat, feeling of throat closing. Solu-medrol and IV fluids were administered. Patient felt much better and was discharged with a prescription for oral prednisone. **Note, this information was reported from patient's primary care office. An event have already been reported to VAERS for this patient by Hospital**
60 2021-03-23 blood pressure increased developed life threatening high blood pressure; This is a spontaneous report from a contactable nurs... Read more
developed life threatening high blood pressure; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EN6199), via an unspecified route of administration in the left arm on 03Mar2021 at 10:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 04Mar2021 at 02:30, the patient developed life threatening high blood pressure. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the event. The outcome of events was not recovered.; Sender's Comments: Based on the strong temporal relation in the case report, a causal relationship between adverse event Blood pressure increased and suspect product BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-03-23 chest pain, chest discomfort patient states she is having chest tightness and pain around 10 minutes after vaccination. BP 160s/1... Read more
patient states she is having chest tightness and pain around 10 minutes after vaccination. BP 160s/110s. Clinic provider notified. Transferred to ED at patient request.
60 2021-03-24 fainting Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hi... Read more
Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hip, sore to touch, tired. Day 3 bone, muscle pain moved upper back, tired. Took aspirin. Day 4 bone, muscle pain more extreme, tired. Took aspirin. Day 5 extreme pain in hip and ribs, sore to touch hard to breath, fainted, tired. Took tylenol. Pain went away
60 2021-03-25 pallor The VR has a history of vagal response to immunizations and blood. The VR had the vaccine without i... Read more
The VR has a history of vagal response to immunizations and blood. The VR had the vaccine without incident and went to the observation area. The VR was then sitting with his wife when he "was thinking of the vaccine" and he became unresponsive. I was called to the site. The VR was pale, cool, and diaphoretic. The VR became responsive and was assisted to the cot where he laid flat. The VR's wife states that this is typical behavior and response for him. An ambulance was called by the paramedics that were on scene in the observation area. The VR refused transport. The VR was given water and candy and was able to ambulate without difficulty. VR remained in the observation area for 40 minutes and then discharg
60 2021-03-25 hypertension, loss of consciousness things went black; my blood pressure was alarmed was over 200 checked other arm same called there te... Read more
things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
60 2021-03-26 chest discomfort 100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fati... Read more
100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fatigue, headache.
60 2021-03-26 blood pressure decreased, blood pressure increased My blood pressure shot up the first night. It came down for a while Wed and Fri, but shot back up to... Read more
My blood pressure shot up the first night. It came down for a while Wed and Fri, but shot back up to 181/102 Sat. I take Clonidine when it goes over 160. I have had several this week. My pulse has stayed in the 60s and 70s. My oxygen saturation has been above 95.
60 2021-03-27 fainting Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness... Read more
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
60 2021-03-28 palpitations BP 153/89, HR 84,O2 100%, 12 lead normal. Anxiety, weakness, palpitations. Exit time 11:22 am.
60 2021-03-28 heart rate increased, blood pressure increased, chest discomfort Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy W... Read more
Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy Weakness
60 2021-03-30 palpitations Within 5 minutes, patient began to have blurry vision, chest pounding, and trouble breathing. Epinep... Read more
Within 5 minutes, patient began to have blurry vision, chest pounding, and trouble breathing. Epinephrine (patient thinks 2 doses) and Benadryl administered in the field. Patient brought to hospital by ambulance where she received IV SoluMedrol, Pepcid, Benadryl, and fluids scheduled throughout hospitalization. Patient improved and was discharged the following day (3/27/21).
60 2021-03-30 fainting fainted; This is a spontaneous report from a contactable consumer (patient) reported that a 60-year-... Read more
fainted; This is a spontaneous report from a contactable consumer (patient) reported that a 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 11:30 as a single dose (at the age of 60-years-old) for covid-19 immunisation. The patient medical history was reported as none. The patient was not pregnant at the time of vaccination. Concomitant medications included glipizide and lisinopril both were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 14:30, the patient fainted and was rushed to the hospital and admitted with outcome of recovered on Mar2021. The reported event resulted in emergency room/department or urgent care, and hospitalization for 1 day on an unspecified date. The patient received treatment for the reported event as Catscan (as reported). The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 13Mar2021. Information on Lot/batch number has been requested.
60 2021-04-03 arrhythmia, atrial fibrillation 12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post... Read more
12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.
60 2021-04-03 atrial fibrillation, palpitations Pt reports onset on nausea and palpitations approximately 10 hours after receiving first dose of vac... Read more
Pt reports onset on nausea and palpitations approximately 10 hours after receiving first dose of vaccine. Pt reports Emergency room visit, where she states she was diagnosed with atrial fibrillation. Pt reports she underwent 3 days of hospitalization, converting spontaneously without treatment to normal sinus rhythm.
60 2021-04-05 chest discomfort Became nauseated has itchy throat and chest tightness with in 5 mins of receiving the vaccine
60 2021-04-06 heart rate increased rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontan... Read more
rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in the right arm in a hospital facility on 10Mar2021 at 12:30 PM (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks and had no additional vaccination administered on same date of the Pfizer suspect. The patient had no medical history (including any illness at time of vaccination. The patient had no family history. Ongoing concomitant medications included amlodipine besylate from 2019, vitamin D3 taken for general health, calcium taken for bone density, and fish oil taken for heart health. On 12Mar2021, the patient experienced rapid heartbeat. The patient continues to have rapid heartbeat "on and off." The patient asked if it was considered a severe allergic reaction. The patient added that she went to the ER and was admitted to the hospital on 12Mar2021 and discharged on 14Mar2021 due to rapid heartbeat. While hospitalized they did an electrocardiogram (EKG); and Echocardiogram and a computerized tomogram (CT) of the heart and chest and all showed no heart disease and no pulmonary embolism. Adds whenever she gets up and does some slight activity, her heart goes for about 30 seconds. Sometimes it goes from 70 to 115 and then goes back. also added that she was going to see her primary care doctor on 29Mar2021 about it. She was scheduled to get the next dose but she was asking if she should get the next dose. She also added that she has been having insomnia on 12Mar2021 ever since she went to the hospital and it was still happening because she was so anxious about this. The events did require emergency room visit but did not required physician office visit. Therapeutic measures were taken as a result of rapid heartbeat which includes amlodipine and metoprolol. The patient had not yet recovered from rapid heartbeat and insomnia.
60 2021-04-07 chest pain shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital ... Read more
shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital and discharged on 4/2
60 2021-04-09 loss of consciousness Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; ... Read more
Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; Anaphylaxis; chest hurt to breathe; Itching in my arms and chest in the evening.; rash; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left arm on 15Mar2021 at 17:00 (Batch/Lot Number: EP8534) as SINGLE DOSE for covid-19 immunisation. Medical history included Only occasional migraines. Never anything like this and known allergies: Some grasses. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021, at 8pm, the patient reported that "3 days after 2nd shot I started itching in my arms and chest in the evening. Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor. My rash was worse and spreading and chest hurt to breathe and I had bumps on head so we called # and nurse and my husband drove me to (Name). They gave me an IV and epinephrine shot and Pepcid and did CT scan of head and blood work. Diagnosed Anaphylaxis. They sent me home a couple hours later with prescription for Epi pens Zyrtec and Famotidine. Over the course of Friday my rash/hives got worse and spread over my body and my lips /mouth started to swell. I called the nurse who suggested I come back in and they checked by throat to ensure it wasn't closing up and gave me ibuprofen and Benadryl and sent me home. Rash/hives worse and spread all over body and face when I woke up Saturday morning (today). Plan to see specialist Sunday or Monday." The outcome of the events was not recovered. The patient was not tested for COVID-19 after vaccination.
60 2021-04-12 pulmonary embolism Two weeks after 1st Pfizer shot I began to have very heavy breathing while on a daily walk that cont... Read more
Two weeks after 1st Pfizer shot I began to have very heavy breathing while on a daily walk that continued with any exertion. It continued for several days. I called PCP and was seen. Chest Xray & bloodwork was done. Was called to go to E.R. for CT scan of lungs. Pulmonary Embolisims were seen and a blood thinner was given. Heart monitored for previous Afib (ablation performed 5 yrs ago). CT scan w/dye was done of abdomen, Right leg ultrasound with compare L, MRI w/contrast done of abdomen/pelvis. No reason has been found for cause of several blood clots in both lungs - sub arteries. Am being followed up by Vascular Doctors in 2 weeks.
60 2021-04-14 pulmonary embolism Pt developed symptoms of a pulmonary embolism (4/3/21) 10 days after 1st vaccine (3/24/21) Presented... Read more
Pt developed symptoms of a pulmonary embolism (4/3/21) 10 days after 1st vaccine (3/24/21) Presented to hospital 4/12 with progressive symptoms. Diagnosed and started on blood thinners with tpa administration for severe right heart strain followed by discharge home.
60 2021-04-15 pulmonary embolism Felt sick with covid like symptoms beginning 4/2, Shortness of breath began 4/3, received negative c... Read more
Felt sick with covid like symptoms beginning 4/2, Shortness of breath began 4/3, received negative covid test on 4/7, went to ER on 4/12, CT scan showed MASSIVE bilateral Pulmonary embolism, Angiogram of heart showed right side under stress at 50%. 4/13 Surgery - catheterized directed thrombosis to dissolve clots. Discharged from hospital 4/15
60 2021-04-18 deep vein blood clot Deep Vein Thrombosis right leg, superficial femoral vein to popliteal vein and distal
60 2021-04-20 blood clot, pallor, fainting I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all co... Read more
I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.
60 2021-04-24 blood clot Blood Clot; This is a spontaneous report from a contactable nurse. A 60-year-old female patient (no... Read more
Blood Clot; This is a spontaneous report from a contactable nurse. A 60-year-old female patient (no pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208), intramuscular at the age 60-year-old at arm right on 11Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular at the 60-year-old at right arm on 19Feb2021 for COVID-19 immunisation and experienced pneumonia. There was no other vaccine in four weeks. Facility type vaccine was reported as public health clinic/administration facility. The patient experienced blood clot on Mar2021 after 2nd. The patient was hospitalized for event for 5 days. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness. The patient received the treatment for event. The outcome of event was unknown.; Sender's Comments: Based on information available, a possible contribution role of the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of event clot blood cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021422806 same patient/product, different dose and event
60 2021-04-26 fast heart rate Tachycardia within 5 minutes of injection. Elevated HR for about 3 days; This is a spontaneous repo... Read more
Tachycardia within 5 minutes of injection. Elevated HR for about 3 days; This is a spontaneous report from a contactable consumer (Patient herself). A 60-year-old non-pregnant female patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201, Expiration date: Unknown) via an unspecified route of administration in the left arm on 09Feb2021 12:15 as SINGLE DOSE for covid-19 immunisation. The patient's medical history included genital herpes and gastro oesophageal reflux disease from an unknown date and unknown if ongoing. The patient previously took morphine and flagyl and experienced drug hypersensitivity. The patients concomitant medications were not reported. On 09Feb2021 12:30 she experienced tachycardia within 5 minutes of injection and she had elevated heart rate for about 3 days on. She also had other medications in two weeks. She had no other vaccine in four weeks. The patient underwent lab tests and procedures which included heart rate: elevated. The outcome of event was recovered with sequele.
60 2021-04-26 lightheadedness This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old fem... Read more
This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
60 2021-04-26 loss of consciousness, fainting This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt1... Read more
This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:30 (at the age of 60-years-old) (Batch/Lot Number: ER-8730) as SINGLE DOSE for covid-19 immunization. Medical history included Hypothyroid, High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID); losartan potassium (LOSARTIN); amlodipine; hydrochlorothiazide; all taken for unspecified indications, start and stop dates were not reported. On 27Mar2021 13:30, the patient experienced Bleeding at the site, fainting and vomiting while passed out for 5 minutes. The patient believes the injection was too high and she hit a vein. It was further reported that the patient is not a squeamish person and have never had reactions to any shots or blood draws in the past. The event fainting and passed out was assessed as serious (medically significant). Therapeutic measures were taken as a result of bleeding at the site. The patient did not receive treatment for the events fainting, passed out, and vomiting. The outcome of the events was recovered.
60 2021-04-27 deep vein blood clot DVT Right Leg; This is a spontaneous report from a contactable other healthcare professional (patien... Read more
DVT Right Leg; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 04Feb2021 08:30 (Lot Number: EL1283), at the age of 60-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included osteoarthritis, asthma, fibromyalgia. Historical vaccine includes first dose of BNT162B2, Lot number: EL1283, on 14Jan2021 08:45 AM in left arm at the age of 60-years. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. Concomitant medications included etodolac (LODINE); montelukast; amitriptyline; acetylsalicylic acid (BREOPRIN), all were taken for unspecified indication, start and stop date were not reported. The patient previously took Vioxx and experienced allergies. The patient experienced DVT on right leg on 21Feb2021 with outcome of recovered. The event required physician office visit. The patient has not been tested for COVID-19 post vaccination. Therapeutic measures were taken as a result of DVT in right leg which includes Eliquis.
60 2021-04-27 heart attack heart attack; This is a spontaneous report from a contactable consumer (patient herself). This 60-y... Read more
heart attack; This is a spontaneous report from a contactable consumer (patient herself). This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration in the right arm, on 06Mar2021 at 15:30 (Lot number EN6203) as single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration in the left arm, on 27Mar2021 at 15:30 (Lot number EP7534) as single dose, for COVID-19 immunisation. Relevant medical history included allergy to nickel and latex). Past drug history included allergy to penicillin. Relevant concomitant medications included ezetimibe, chondroitin sulfate, glucosamine, biotin and vitamin (unspecified). No other vaccine was received in four weeks. The patient had a mild heart attack approximately two weeks after her first dose of the vaccine (untreated) in Mar2021 and a major heart attack 2 weeks to the day after her second dose (11Apr2021, at 02:00). The patient visited the emergency room and she was hospitalized for 5 days. The event was also considered serious as life-threatening. Therapeutic measures taken as result of the event includes angioplasty. The patient was recovering from the event.
60 2021-04-27 cerebrovascular accident thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is e... Read more
thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure high diagnosed about 7-8 years ago. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid vaccine on 09Apr2021. On Saturday, 10Apr2021, she got this severe cramp in her left leg below the knee to her toes and it is extremely painful and thought she was having stroke. She stated that she was treating with a warm cloth and was going to go to the emergency room; rubbing down in case there is a blood clot. She wanted to know if this could be from the vaccine. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
60 2021-04-28 pulmonary embolism, blood clot, chest pain multiple pulmonary embolisms/Pulmonary embolism and subsegmental pulmonary embolus; felt sluggish di... Read more
multiple pulmonary embolisms/Pulmonary embolism and subsegmental pulmonary embolus; felt sluggish directly; feeling discomfort in my lungs; pain in my lung/chest area; pain in my lung/chest area/right-sided chest pain under the rib; difficult and extremely painful to breathe/significant shortness of breath/shortness of breath due to extreme pain; blood clots; This is a spontaneous report from a contactable consumer (patient) and physician. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 07Apr2021 17:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at time of vaccination. The patient's concomitant medications included cetirizine, diphenhydramine, and phenylephrine. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), right arm first dose on 10Mar2021 for COVID-19 Immunization. On 07Apr2021 21:30, the patient felt sluggish directly after receiving the second dose. The patient began feeling discomfort in my lungs about 5 hours after the dose. The pain in my lung/chest area grew worse throughout the night to the point where it was difficult and extremely painful to breathe. The patient went to urgent care in the morning, and they ran an EKG, urine analysis, and chest X-ray: all with unknown results. They were concerned it could be something worse along with potential pneumonia, so they sent me to the emergency room. In the emergency room, I received a CT scan where they found multiple pulmonary embolisms (1 large one in my right and multiple in my left lung). The patient stated that she had just had my yearly physical the previous week (Apr2021), with no signs of any health issues. With that, the doctors believed my condition to be related to my 2nd dose, so I was admitted to the hospital. I had to stayed for 2 nights. I am now on blood thinners, other meds (pain medications), and require oxygen during sleep (O2 levels drop too low). I have been referred to lung and hematology specialists. Also, reported that patient experiencing significant shortness of breath and right-sided chest pain under the rib. This persisted for some time until she presented to the emergency department found to have segmental and subsegmental pulmonary embolus. Additionally, the patient experienced blood clots, chest pain, and shortness of breath due to extreme pain. Hypercoagulable work-up pending. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
60 2021-04-30 oxygen saturation decreased, fainting, fibrin d dimer increased, deep vein blood clot DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable... Read more
DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable/discomfort; nights were the worst for the pain; pulse ox was low; d-dimer was very high; fainted; Fracture of ankle/two fractures on her ankle; severely nauseous; Vomiting; Diarrhea; deathly sick; This is a spontaneous report from a contactable consumer, reporting for herself. A 60-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER8727), via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included osteoporosis at least 10 years, terrible nausea, mild case of covid from Nov2020 to an unknown date. There were no concomitant medications. The patient previously took alendronate from 2008 to an unknown date and experienced very sick, nausea, diarrhoea and zoledronic acid (RECLAST) from Dec2017 and experienced nausea and vomiting. On 27Mar2021 at 2:00, the patient experienced deathly sick, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, and diarrhea. On an unknown date, the patient experienced dvt blood clot, ankle was still swollen and uncomfortable/discomfort, the nights are the worst for the pain, pulse ox was low, and d-dimer was very high. The event, deathly sick, was life-threatening. The clinical course was as follows: the patient had the first dose of the vaccine on 26Mar2021 at 14:00 in the afternoon in her left arm. Twelve hours after the first dose, later in the night about 02:00 AM she woke up deathly sick; and severely nauseous. She remembered she was going to the bathroom then she must have fainted because they were taking her to the hospital. She went to the ER and they found she had a fractured ankle. She was not admitted to the hospital. She was in the ER from about 03:00 AM to noon the next day. There must have been something in there; she knew there must be something in the vaccine because of her reaction. Adds a few years ago, something like this happened before. She had osteoporosis and had similar reactions with other products she had tried for osteoporosis; she had terrible nausea. The other products she tried included: in 2008 she took alendronate, it made her very sick but not as severe as this time, she never fainted. She had nausea and diarrhea. Then in Dec2017 she had zoledronic acid. She went for an infusion at the hospital then went shopping, and was fine until the early morning, when she woke up with nausea and vomiting. In the ambulance, they gave her ondasetron (ZOFRAN) for the nausea so the vomiting stopped. With regard to her ankle, first they thought it was a DVT blood clot. They did the xray and saw actually two fractures on her ankle but she does not need surgery. She saw the orthopedic doctor the other day and he said her ankle was healing but she still will have no weight bearing for 6 weeks and she was in a boot. Adds her ankle was still swollen and uncomfortable. She hated to take medications and they gave her oxy but she didn't want to take it. She was taking ibuprofen but that messed up her stomach. The nights are the worst for the pain and discomfort. Doctor at the hospital and primary care agreed she should not have the second dose. She did have mild case of COVID in Nov2020 and they are hoping she had antibodies from the infection and the first dose. Her primary care doctor was reviewing the blood work she had done at the hospital and told her they were surprised the hospital didn't admit her for observation because her pulse ox was low and there was another test that she was questioning because the d-dimer was very high. They did a chest x ray with unknown results. The doctor was questioning why they didn't do something else to rule out a blood clot. Therapeutic measures were taken as a result of the events, deathly sick, DVT blood clot, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, diarrhea, ankle was still swollen and uncomfortable/discomfort, nights were the worst for the pain, pulse ox was low, and d-dimer was very high. The clinical outcome of the events, deathly sick, fainted, severely nauseous, vomiting, diarrhea, was recovered on 27Mar2021. The clinical outcome of the events, DVT blood clot and nights were the worst for the pain, pulse ox was low, and d-dimer was very high, was unknown. The clinical outcome of the event, fracture of ankle/two fractures on her ankle, was recovering. The clinical outcome of the event, ankle was still swollen and uncomfortable/discomfort, was not recovered. No follow-up attempts are needed. No further information is expected.
60 2021-04-30 nosebleed anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both,... Read more
anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.
60 2021-04-30 chest pain my chest started hurting; I couldn't breathe; This is a spontaneous report from a contactable health... Read more
my chest started hurting; I couldn't breathe; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 16:00 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included mild asthma. The patient is not pregnant. Concomitant medications included lisinopril; fexofenadine hydrochloride (ALLEGRA); and estradiol. The patient previously took morphine, tramadol, and nickel and all had known allergies. The patient experienced her chest started hurting and she couldn't breathe the next day (29Dec2020). She slept for 2 days. Symptoms progressed and got worse and she had been to the emergency room (ER) five times. She also had many Doctor (Dr) appointments and symptoms had not improved. The events assessed as serious with disability and hospitalization of one day. Treatment received for these events included dexamethasone, duo neb, lorazepam, and hydromorphone. No COVID prior to vaccination and COVID tested post vaccine (unspecified date): unknown results. No other vaccines received in four weeks. The outcome of the events was not recovered. Information on about lot /batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
60 2021-05-02 loss of consciousness Patient was working in the traffic area of the parking lot. The patient was exiting the area after t... Read more
Patient was working in the traffic area of the parking lot. The patient was exiting the area after the 15 min observation period. She reported no symptoms or complications prior to leaving the area and no usual behavior was noted at this time. Patient was accompanied by her husband and son. Near the parking lot the patient was witnessed losing consciousness and falling to the ground. Patient immediately assisted the patient and also called for assistance. I was notified immediately and myself, the paramedics on sight, and NP responded to the patient incident. The patient was diaphoretic and had abnormal vital signs that were repeated multiple times. The set I obtained were 117 heart rate, 99% oxygen on room air, 167/94, 225/112, both taken lying down. Patient complained of severe headache, blurry vision, tinnitus, and dizziness over the past 2 days prior to days. Patient reports having only one medical condition, psoriasis, and takes a cream for it, but also reports she has not seen a doctor in "many years". No stroke symptoms were observed.
60 2021-05-04 hypertension blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back ha... Read more
blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose
60 2021-05-09 haemoglobin decreased April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark ... Read more
April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark urine Jaundice went to urgent care, they advised i go to ER as they felt i needed an abdominal scan to see why i had so much bilirubin in my urine. Went to Hospital. CBC showed my hemoglobin was 5.9. Went down to 4.9 before first transfusionhad CT SCan and sonogram.. Was admitted and disagnosed with hemolytic Anemia brought on by Covid Vaccine. had 5 blood transfusions over the course of my 8 day hospital stay. As of 5/06/21 My hemogloblin is 10.3 and has been at this level for past three weeks, I am currently under the care of a hemotologist
61 2021-01-03 chest discomfort, heart rate increased, lightheadedness, blood pressure increased About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, ... Read more
About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation
61 2021-01-04 heart rate increased Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseat... Read more
Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.
61 2021-01-05 coughing up blood, cardiac arrest coughing up blood, significant hemoptysis -- > cardiac arrest. started day after vaccine but likely ... Read more
coughing up blood, significant hemoptysis -- > cardiac arrest. started day after vaccine but likely related to ongoing progression of lung cancer
61 2021-01-05 chest discomfort, chest pain dizzyness within minutes. was told by nurse onsite this was not an adverse reaction. the paperwork ... Read more
dizzyness within minutes. was told by nurse onsite this was not an adverse reaction. the paperwork they gave stated otherwise. after about 30-40 mins the dizzyness subsided. no treatment. chest pain. not sure if heart or lungs. was not due to eating as symptom was steadily getting worse across 3 days whether I ate or not. was difficult to eat due to the pain. didnt matter if was sitting, standing or laying down. felt like saran wrap around my heart...sqeezing it...with pain. pain stayed centered in chest. behind sternum. still there, but tonight does seem a little better. was not intermittetent but was more pain sometimes and less pain sometimes. longterm outcomes unkn.
61 2021-01-06 blood pressure increased, heart rate increased Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside t... Read more
Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-01-06 chest discomfort Within several minutes after receiving the vaccine she began experiencing chest tightness. She was g... Read more
Within several minutes after receiving the vaccine she began experiencing chest tightness. She was given oxygen and benedryl but the chest tightness worsened and EMS was called. She was transported to the ED.
61 2021-01-07 blood glucose increased Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet... Read more
Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; Average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also achiness, and tiredness.; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection via an unspecified route of administration on left arm on 22Dec2020 02:30 at a single dose for Covid-19 immunization. Medical history included CREST Syndrome, type 2 diabetes, osteoarthritis, allergies to Sulfa and Dermabond tape. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient took other medications in the last two weeks. On 26Dec2020, the patient experienced average increase in blood sugar levels by 50 to 80 points, that haven't returned to prior levels yet. Also, she experienced achiness, and tiredness on 26Dec2020. No treatment received for the events. The patient was not diagnosed with Covid-19 and has not been tested prior to vaccination. Outcome of the events was unknown. No follow-up activities are needed. No further information is expected.
61 2021-01-07 chest discomfort, fast heart rate Tachycardia (HR in the 110s), substernal chest pressure, dizziness 15 min post vax Observation and f... Read more
Tachycardia (HR in the 110s), substernal chest pressure, dizziness 15 min post vax Observation and fluids Sxs resolved after 30 mins of close monitoring NKA
61 2021-01-07 blood glucose increased patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral ... Read more
patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out
61 2021-01-08 heart rate increased About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left d... Read more
About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.
61 2021-01-08 heart rate increased First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next da... Read more
First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.
61 2021-01-10 heart rate increased Elevated heart rate to 120, fever, shortness of breath, headache
61 2021-01-10 hypertension I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a... Read more
I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a few days after.
61 2021-01-10 chest pain Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to... Read more
Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to touch.
61 2021-01-12 chest pain Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM i... Read more
Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM in right deltoid. Went to outside ED and placed on BiPAP. Given diphenhydramine, epinephrine, and steroid (unknown doses). Prescribed outpatient epinephrine in case of flare of reaction once stabilized.
61 2021-01-12 nosebleed Three moderate nosebleeds
61 2021-01-12 chest discomfort Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias o... Read more
Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.
61 2021-01-13 fainting, chest discomfort Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determi... Read more
Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ
61 2021-01-14 fainting As stated I fainted about 3 hours after injection. I thought it was because I had worked all night. ... Read more
As stated I fainted about 3 hours after injection. I thought it was because I had worked all night. I fell forward and sustained bruising to my right cheek and temple. I will be reporting another report regarding the second dose with adverse reaction that is the same but required EMS and Emergency Room visit. Approximately 3 hours after injection I was getting ready for bed (as I work nights). I was talking with my daughter and I stood up and remember waking up on the floor. Bruising to the right cheek and temple. I did not seek medical attention and went to bed. I had no further episode but remained dizzy for several days.
61 2021-01-14 loss of consciousness Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on... Read more
Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.
61 2021-01-15 fast heart rate immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by ... Read more
immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by unusual feeling in mouth, not itchy, but tingly-type sensation. lasted about 1 1/2 hours, same reaction happened with both first and second doses, the second time was a little more intense and longer lasting.
61 2021-01-16 cardio-respiratory arrest Ventricular fibrillation- Code blue
61 2021-01-18 blood pressure decreased 1. SOB 2. Flushed 3. Tremble 4. Decrease in blood pressure EpiPen was administered. Attending physi... Read more
1. SOB 2. Flushed 3. Tremble 4. Decrease in blood pressure EpiPen was administered. Attending physician was contacted and advised to send to ER for follow-up and monitoring.
61 2021-01-18 heart rate abnormal Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minute... Read more
Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minutes at a time for next 24 hours. O2 saturation went down as low as 91 but mostly was at 93, heart rate 112 on Jan 13, along with a 100.1 oral temp. I did not Check on Jan 12. Morning of Jan 14: 99 oral temp and 95 O2 saturation. By evening temp and O2 were back to normal: 98° and 98%. Jan 17 I experienced some wheezing. I did have COVID with pneumonia Sept 2020.
61 2021-01-19 fast heart rate After getting this vaccine I start feeling dizzy, headache, fatigue, tachycardia and body aches
61 2021-01-19 chest discomfort Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and ... Read more
Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.
61 2021-01-19 chest discomfort Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccinat... Read more
Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccination. At 1208 on 1/20/2021 pt received 2nd dose of COVID Pfizer vaccine. Immediately after vaccination, pt experienced unusual taste in mouth, flushing, and feeling of heat in chest. At 1232, pt noticed flushing on arms and feelings of heat and pins and needles in both arms, hands, chest, both feet, and back. Sensation was persistent, so at 1301, 50 mg of IM Benadryl administered to RD by NP. By 1320 flushing on arms and chest subsided, feeling of pins and needles persisted but was not as severe as initial reaction. By 1345 flushing on arms returned, pins and needles sensation worsened again in all locations noted prior, spread to scalp, and tingling sensation occurred on lips. Pt communicated with Dr advised to stay under observation, but transfer to ED not medically necessary. At 1415, pt was advised to go home with supervision of partner and monitor symptoms from there.
61 2021-01-19 heart rate increased I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a wa... Read more
I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.
61 2021-01-19 heart rate increased Rapid heart Rate that began about 12 hours after the injection. Heart rate of 123 all night and wen... Read more
Rapid heart Rate that began about 12 hours after the injection. Heart rate of 123 all night and went to ER next morning after calling Nurse on Call system. I was admitted and the Dr ordered bag after bag of fluids to and kept me in the unit overnight for observation. Did may hear tests (EKG, ECHO STRESS,CTA chest) and results all came back good. I was released on 1/19/21 at 2pm and my hear rate is back to normal (82 bpm).
61 2021-01-19 chest discomfort Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours... Read more
Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.
61 2021-01-20 palpitations Felt that my heart was racing , I also felt light headed. I was sent to the ER to be monitored for 4... Read more
Felt that my heart was racing , I also felt light headed. I was sent to the ER to be monitored for 4 hours.. they checked my vital and sent me home after everything was clear .
61 2021-01-20 hypertension High Blood Pressure - 211/101 (initial reading) - stayed high for five or six days. Headache becaus... Read more
High Blood Pressure - 211/101 (initial reading) - stayed high for five or six days. Headache because your blood pressure was so high. Dr visit (Telemed) and they increased the dosage one of my medications - the Quantitine (from 0.1 mg pill to one and half pills now and the Hydrochlorizide (to twice a day), That resolved it.
61 2021-01-21 palpitations, heart rate increased Palpitations with elevated heart rate and some chills.
61 2021-01-21 chest pain STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine.... Read more
STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)
61 2021-01-23 heart rate increased, hypertension 10:58 Reported increased HR HR 77-80, BP 138/90, Reported High HR and High BP. Water provided. 11:1... Read more
10:58 Reported increased HR HR 77-80, BP 138/90, Reported High HR and High BP. Water provided. 11:15 HR 77, BP 132/80, Reports feels better and this is a normal feeling for her. Encouraged to notify PCP
61 2021-01-24 fainting Chills. Fever. Nausea. Vomiting. Fainted
61 2021-01-24 hypertension, pulse abnormal, fainting, fast heart rate Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfor... Read more
Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
61 2021-01-24 nosebleed Nose bleed never ever do i get nose bleeds 19 hours after vaccine very odd This was my second vaccin... Read more
Nose bleed never ever do i get nose bleeds 19 hours after vaccine very odd This was my second vaccine nothing happened with the first one
61 2021-01-27 blood pressure increased 10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; t... Read more
10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on
61 2021-01-27 cardiac arrest Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been r... Read more
Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.
61 2021-01-27 heart rate increased Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for... Read more
Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.
61 2021-01-29 fast heart rate, hypertension, lightheadedness, pallor alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves ... Read more
alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.
61 2021-01-30 chest discomfort Bad headache Tight chest Shortness of breath Chills
61 2021-01-31 chest pain Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness... Read more
Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.
61 2021-01-31 chest discomfort Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHI... Read more
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHING-Medium
61 2021-02-03 blood pressure increased 61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after... Read more
61-year-old female presents the ED for evaluation of lightheadedness. Patient reports shortly after receiving first dose of Covid vaccine, began to feel lightheadedness 15 minutes later. Patient reports that she started off with a right-sided headache, and when she went to stand up took 2-3 steps forward and fell lightheaded, and and sat back in her chair. Denies loss of consciousness, chest pain, shortness of breath. Denies alleviating or exacerbating factors. Patient reports that they taken her blood pressure after symptoms, was found to be elevated, 200/100 systolic. Patient denies previous history of blood pressure medications. Denies previous reactions to vaccines
61 2021-02-04 loss of consciousness I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:3... Read more
I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:30 AM on 2/5/21, I passed out three times after rising from the toilet, resulting in a split lip. I was covered with sweat the third time I "came to" and soon got the chills.
61 2021-02-04 chest discomfort, cerebrovascular accident Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, diz... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.
61 2021-02-04 hypertension feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was ... Read more
feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.
61 2021-02-06 chest pain Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with... Read more
Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with heart monitor on patient. EKG WNL B./P 140/97, HR 57 o2 Sat 100 %Ambulance transported patient to Hospital.
61 2021-02-07 blood pressure increased Elevated blood pressure
61 2021-02-07 fast heart rate Patient stated she felt tachycardic post vaccination [BP 176/95 mm/Hg & HR 78] enhanced observation ... Read more
Patient stated she felt tachycardic post vaccination [BP 176/95 mm/Hg & HR 78] enhanced observation vitals improved slightly [173/94 mm/Hg & 74 BPM.] Patient stated she felt better,
61 2021-02-08 chest discomfort From charting for point of care services before EMS transport: Chief Complaint: Immunization Visi... Read more
From charting for point of care services before EMS transport: Chief Complaint: Immunization Visit: Client received Pfizer Vaccine at 11:30am. At 11:32 am client reports "throat feels a little funny" and Chest tightness. No difficulty breathing reported. Lung sounds clear bilaterally per RN at 11:38am. Pt reports that her throat still feels funny after administration of benadryl by RN. Epi was administered at 11:40am by RN. EMS arrived at 11:42am. Client has is now complaining of jaw pain. Reports shoulder pain ( residual from recent accident). Vital signs obtained by RN Her husband was present when EMS arrived and will follow client to the hospital.
61 2021-02-08 palpitations Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more tha... Read more
Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more than 80 and was regular). Discomfort in arm began, progressed to inflammation and difficulty in movement of arm especially to lift arm. Used Tylenol or Motrin PRN for relief as well as heating pad intermittently. After 1/23 injection discomfort seemed to lessen but on 2/9 (4 days before second injection due) discomfort still persists. Due to persistence of symptoms seen in Urgent Care diagnosis Adhesive Capsulitis of right shoulder and acute pain of right shoulder. Treatment, Physical Therapy and Ibuprofen. Unable to use steroids due to diabetes. Follow up scheduled 2 weeks 2/16/2021.
61 2021-02-08 heart rate increased, hypertension Rapid heart beat, high blood pressure, sinuses blocked, and anxiety.
61 2021-02-11 blood pressure increased AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPOR... Read more
AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPORTS FEELING SMALL AMOUNT OF DRAINAGE IN THROAT. ADMINISTERED 50MG OF DYPHENHYDRAMINE, IM, RO AT 3:43PM. PATIENT MONITERED VITALS EVERY 5 MINUTES. AFTER MEDICATION PATIENT REPORTS FEELING DIZZY AND "LOOPY" AT 5:17PM PATIENT COMPLAINS OF TONGUE SWELLING AND BLOOD PRESSURE ELEVATED. EMS CALLED, ARRIVED AT 5:34PM, PT TRANSPORTED TO NORTHSIDE HOSPITAL. FOLLOW UP CALL, NEXT DAY PATIENT STATES SHE WAS GIVEN STEROIDS IN THE ER AND PRESCRIBED AN EPI PEN FOR FUTURE USE.
61 2021-02-14 fast heart rate, ischemic chest pain Began to have identical symptoms as pericarditis (tachycardia, constant heart pain) 3 days after vac... Read more
Began to have identical symptoms as pericarditis (tachycardia, constant heart pain) 3 days after vaccine. Lasted 3 weeks with around the clock prescription strength ibuprofen. History of viral pericarditis with pericardial effusion which took 1 1/2 years to resolve with cardiologist management. Will not be taking second dose of vaccine.
61 2021-02-16 cerebral haemorrhage, oxygen saturation decreased, troponin increased 61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief compl... Read more
61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.
61 2021-02-23 palpitations, chest discomfort Pt states experiencing heart palpitations and chest pressure.
61 2021-02-25 troponin increased, oxygen saturation decreased, cerebral haemorrhage [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
61 2021-02-26 chest discomfort Lips tingling, throat feels thicker, chest pressure, numbness in fingers. Evaluated by EMS-cleared
61 2021-02-26 hypertension, heart rate increased, palpitations Palpitations lightheaded nauseous Developed high blood pressure Elevated heart rate Blood Tests D... Read more
Palpitations lightheaded nauseous Developed high blood pressure Elevated heart rate Blood Tests Dextrose
61 2021-02-28 heart rate increased Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if... Read more
Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.
61 2021-03-01 fainting, loss of consciousness Patient had a syncope episode aprox. 30 minutes after administration. She passed out while in observ... Read more
Patient had a syncope episode aprox. 30 minutes after administration. She passed out while in observation. Paramedics on scene responded and gathered information. She passed out again and at that point she was put on the stretcher and brought to a nearby hospital.
61 2021-03-02 heart rate increased As soon as injection I got a horrible taste in my mouth then wi seconds my heart rate increased then... Read more
As soon as injection I got a horrible taste in my mouth then wi seconds my heart rate increased then some shortness of breath, that lasted less then a minute approx 5 minutes later a bad headache started then I felt extremely tired the headache lasted about 5 minutes the tired about 15. Nothing was needed everything got better on its own.
61 2021-03-02 hypertension, heart rate increased Increased heart rate following second dose; they took her blood pressure which was 193; she feels a ... Read more
Increased heart rate following second dose; they took her blood pressure which was 193; she feels a little lightheaded still; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm shoulder (as reported) on 29Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for 2 holes in the heart), complete heart valve replacement in Oct2017 and ongoing, "pacemaker" from Oct2017 and ongoing. Concomitant medication included metoprolol for thyroid condition, amlodipine for high blood pressure, clarithromycin (CLARITIN [CLARITHROMYCIN]) for allergies; all from 2017 and ongoing. Patient previously took first dose of BNT16B2 on an unspecified date for COVID-19 immunization and experienced heart rate increased. She was brought to the emergency room and they gave her an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. Family medical history included mother and sister died from lung cancer; father died of pancreatic cancer. Heart rate increased following second dose of Pfizer-BioNTech COVID-19 vaccine administered on 29Jan2021; onset of event was in the afternoon on 30Jan2021 while at work. Her heart kind of jumped, skipped a beat and then just took off; she could feel her body twerking. Her heart rate went up to 193 beats per minute. She went to the nurses station at work, they took her blood pressure which was 193-verified this as same number of bpm of heart rate-documented as provided. That nurse told her she should go to the hospital, so patient just left work and walked to the hospital which was a block away from work. She did not feel lightheaded, sick, or pain, just heart racing. She was again seen in the emergency room in response to this event, but was not admitted to the hospital. She was again given an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. The only thing still ongoing related to this event was that she feels a little lightheaded still. Relevant Tests: All were good. They tested her kidneys, heart did an X-ray, EKG; tested her liver and thyroid and they said everything came back good; They said her heart rhythm was fast, and irregular, but something else was normal-she does not remember what that was. She had no further details or results for testing/investigations to provide at this time. Outcome of increased heart rate was recovered while outcome of the remaining events was unknown. Information on the batch number has been requested.
61 2021-03-02 chest discomfort Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right si... Read more
Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right sided chest pressure with shortness of breath. Used her inhaler, which helped with shortness of breath. EMS was called and patient was transported to the ED where she also endorsed a headache. EKG showed some ST depression with T-wave inversion that was not present in 2008. Patient was monitored for a few hours - had 2 negative troponins and repeat EKG and was discharged home.
61 2021-03-03 fast heart rate Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chil... Read more
Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chills, throat discomfort. Patient had improvement with water, O2 and juice. Patient left in wheelchair after 90 minutes of observation with resolution of tachycardia and throat discomfort.. States she had similar reactions to influenza vaccine in past, but did not last that long. We discussed ER evaluation at which patient elected to go home as she had driver and wanted to go home. Patient instructed Benadryl, rest and fluids day of event. 911/ER if worsening symptoms. Patient in agreement to plan.
61 2021-03-04 nosebleed, blood clot still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 wen... Read more
still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-03-05 chest discomfort Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD d... Read more
Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!
61 2021-03-06 palpitations Heart Palpitations, refused to be seen by EMS. Cleared by medics
61 2021-03-06 atrial fibrillation I am having ongoing Atrial Fibrillation
61 2021-03-06 fast heart rate On day 2, I developed confusion and could not focus making it impossible for me to complete my work ... Read more
On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.
61 2021-03-07 chest discomfort 110/68 97% pulse83 Left arm injection. Client reports heaviness in right arm pressure in her chest ... Read more
110/68 97% pulse83 Left arm injection. Client reports heaviness in right arm pressure in her chest almost immediate 10:10 108/68- pulse 96 pso2 97% right arm heaviness- chest pressure resolved. Client declined ER visit and requested to leave, spouse present will drive client home.
61 2021-03-08 heart rate increased Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on... Read more
Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on fire. Hoarse voice and constant clearing of throat due to production of phlegm in throat. Tingling lips and tongue. This continued all day until I took 10 mg of prednisone. Within 3 hours, all symptoms were gone. Slept well all night. The next day (Wednesday) I felt fine. Slept fine Wednesday night. Thursday morning, all of the above symptoms returned. I took 5 mg prednisone, which didn?t alleviate symptoms so I took an additional 5 mg. I also took 2 Benadryl. Symptoms went away. Slept well Thursday night. Friday morning they returned. I had a doctor?s appointment scheduled (new patient visit) which I canceled as the office told me to go to the ER at the hospital where I got my shot. By the time I got to the ER, my symptoms had subsided. The ER doctor gave me 60 mg of prednisone, 1 famotidine, Benadryl.
61 2021-03-08 hypotension Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, t... Read more
Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, took a big swig of Benadryl, went to Fire station, transported by ambulance to ER, blood pressure got way too low on ambulance ride, difficulty breathing/taking air in, IV applied - hospital by 6:30 PM, breathing still difficult, blood pressure better until it dropped again, IV given and monitored. Stable and discharged around midnight. Friday - Tuesday - very tired, heavy arms and legs, sore throat and tongue, limited to soft, bland. foods.
61 2021-03-08 nosebleed Woke up at 1 am to use restroom and noticed dripping from the nose and noticed it was blood. I have... Read more
Woke up at 1 am to use restroom and noticed dripping from the nose and noticed it was blood. I have never had a bloody nose where it actually was running from the nose.
61 2021-03-10 blood pressure increased, chest discomfort Dizziness at 5 to ten minutes of injection , elevated blood pressure. Dizziness was improving after ... Read more
Dizziness at 5 to ten minutes of injection , elevated blood pressure. Dizziness was improving after 30 minutes so I was allowed to leave the vaccination facility shortness of Breath started 35 o 40 minutes after injection. When I was was walking out to my car My daughter was in area and picked me up and she had Benadryl Took 2 Benadryl Shortness of breath started to improve after An hour of Benadryl. Hoarse voice improved some but continued to improve after second dose of Benadryl. Now on March 11 I still have a slight hoarse voice but so much better. I?ve been taking Benadryl every 4 to 6 hours regularly per my Dr I don?t have shortness of breath anymore but my chest does feel a little tight
61 2021-03-11 nosebleed Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I... Read more
Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.
61 2021-03-11 fainting, hypotension Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
61 2021-03-12 chest pain Pt c/o tingling in throat progressing to difficulty swallowing and mid sternal CP. Pt given 180 mg ... Read more
Pt c/o tingling in throat progressing to difficulty swallowing and mid sternal CP. Pt given 180 mg allegra and with in 5 minutes was feeling better. VS stable. Released to home with instructions. BP: 125/71, P=100z, Pox=97% 1215 BP=129/73, P=103, Pox=97% 1225 BP=121/66, P=82, Pox= 99%
61 2021-03-14 chest discomfort, hypotension, blood pressure increased Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was ... Read more
Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something. hands tingling fingers both hands. NOT hyperventilating. Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.
61 2021-03-14 cerebrovascular accident I had a stroke; This is a spontaneous report from a non-contactable Nurse. A 61-years-old female pat... Read more
I had a stroke; This is a spontaneous report from a non-contactable Nurse. A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3302), via an unspecified route of administration in left arm on 02Feb2021 at single dose for Covid-19 immunisation in hospital. Medical history included hypothyroid. Patient is not pregnant. Concomitant medication included levothyroxine, trazodone, famotidine (PEPCID), cyanocobalamin (VITAMIN B 12). The patient previously took codeine and experienced drug hypersensitivity. Historical vaccination included BNT162B2(lot number:EL3248) on 12Jan2021, in left arm, first dose. No other vaccine in four weeks. No Covid prior vaccination. The patient stated I don't know if it was a result of the Covid shot. But I don't have any comorbidities and I had a stroke on to four which was two days after the shot on 04Feb2021 09:30 with outcome of recovering (as reported). AE result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (2 days), disability or permanent damage. The patient underwent lab tests and procedures which included Nasal Swab, Covid test result: negative. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Despite insufficient clinical information provided, by close temporal relationship and absence of factors which may provide an alternative cause, the company deems there is a reasonable possibility that the reported stroke is related to the suspect drug Comirnaty. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-03-14 fast heart rate Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subs... Read more
Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subsequent abdominal pain with mild diarrhea and then extreme fatigue for 5 hours. Similar to a food allergy reaction
61 2021-03-15 palpitations, increased heart rate, fibrin d dimer increased 61 yo female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She... Read more
61 yo female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She was prescribed metoprolol and a short course of steroids by her pcp for symptomatic relief which patient took 1 dose of metoprolol and did not start steroids. She came to the ED due to her symptoms, Her main concern was why did she react to the Vaccine., and wanted answers.
61 2021-03-15 blood clot I am retired handicap-MS. I was doing light housework. I started getting pain in right lung, over... Read more
I am retired handicap-MS. I was doing light housework. I started getting pain in right lung, over course of 2 hours pain became very severe. Only in right lung. Felt like blood clot or pulmonary embolism (which I had 15 yrs ago). Went to hospital, check X-ray no clot/embolisms. Blood work showed no clotting factor. Was admitted 4 days. We treated possibility of MS reaction (solu-methyl) as well as heparin in event of unknown clotting issue. Here?s why this is strange: If this was MS flare/relapse, I would have muscle lockup, drop foot, sight issues, sever balance issues ...(i always have sight issues).. with this even it was only severe lung pain. Did not appear to be MS driven issue. Being educated ?high analytic person, in reflection, My ms is very territorial, it fights anesthesia, colds/flus/covid when my husband had it. My MS gets cranky when my immune system is attacked. I suspect the second covid injection was doing its thing, dna modification, and I had some lung inflammation and my MS compounded the reaction with crippling issue. I was in hospital 4 days, IV fluids, heparin, and steriod IV. Within first 36 hours the extreme lung pain disappeared and I got better. I do have cats scan, mri, X-rays from stay. Cat scan clear, X-ray, normal, mri-classic ms history. Was this Ms event? I?m not sold as I didn?t have other normal MS flare symptoms. Was this injection aggreviated? Perhaps... I?m sharing this because I think tracking auto immune disease people is important data gathering. Feel free to call if more dialogue is necessary
61 2021-03-15 arrhythmia She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormal... Read more
She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormality; she has heart rhythm problem (premature atrial contraction); feeling exhausted; This is a spontaneous report from a contactable Nurse (patient). A 61 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249), via an unspecified route of administration on 19Jan2021 (at the age of 61 -years-old), single dose for COVID-19 immunization. Medical history included covid infection over a year ago. The patient had no concomitant medicines were not reported. The patient She had flare ups when she took Hep b vaccine before and did not get the 2 remaining doses because of the reaction. She has had so many vaccines over the years and had her flu shot every year. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 19Jan2021. Consulted the doctor 01Feb and told she has heart rhythm problem (premature atrial contraction). She also experienced shortness of breath. Not sure if it is vaccine related or due to her age. She will have the 2nd dose on 09Feb2021. Stated that she was feeling exhausted (29Jan2021) and out of breath. Stated that the doctor told her that her heart rhythm out of sync. Stated that in Dec she had her heart checked and it was okay. Stated that her other Covid is due to be given 09Feb. Does not know if the vaccine is contributing to her heart rate's bivalvular rhythm. Stated that she had Covid infection over a year ago. Stated that she is worried that the vaccine caused an abnormal rhythm to her heart. Stated that she has a new heart rhythm abnormality. Stated that she had all of her lab work done on 11Jan2021 and it was okay. Stated that on 27Jan-28Jan that she tried to pick up a watermelon and was short of breath for no reason. Stated that it happened a couple of times. Stated with her rhythm being out of sync that it feels like her heart is failing. The outcome of the event dyspnea was recovered, heart disorder and fatigue was not recovered, other events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported arrhythmia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
61 2021-03-15 chest pain, blood glucose increased nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; ... Read more
nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
61 2021-03-16 fast heart rate Nausea, tachycardia, dizziness
61 2021-03-16 hypertension, fast heart rate [Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, trem... Read more
[Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, tremors, headache, tachycardia, and hypertension, all without fever.
61 2021-03-17 palpitations 3/17 Headache -- heart racing -- contact doctor's office and took some meds
61 2021-03-17 chest discomfort Pt described later after she got home a "warm sensation in her chest and felt like she swallowed a g... Read more
Pt described later after she got home a "warm sensation in her chest and felt like she swallowed a golf ball". Felt similar to GERD she had in the past but she has not had anything other than the shot to trigger this reaction
61 2021-03-18 hypertension 1. Started Mar 8: Swollen lymph nodes on the right side behind the ear and at the root of sculp. ... Read more
1. Started Mar 8: Swollen lymph nodes on the right side behind the ear and at the root of sculp. Painful, in 4 days started fading away, in 6 days no pain , in 9 days completely gone. 2. started Mar 9: High Blood pressure - 167/97; was taken Amlodipine ( 2*2.5 mg); in 4 days it stabilized. 3. started Mar 14: Fever, treated with Tylenol taking every 6-8 hours. on Mar 19 temp is normal. 4. on Mar 18 Dr. took blood and urine tests. No sings of any abnormality. Came to conclusion - should be vaccine side-effect, report to.
61 2021-03-18 chest pain, chest discomfort At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV a... Read more
At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.
61 2021-03-18 blood pressure increased Patient called Health Department on 3/16/21 at 10:37 am and reported that approximately 40 minutes b... Read more
Patient called Health Department on 3/16/21 at 10:37 am and reported that approximately 40 minutes before call she became extremely dizzy. She has no history of dizziness and no history of health problems. Reports she does take Fosamax on Saturday and normally feels some nausea with that. She did take the Fosamax on 3/13/21. She questioned if this was a normal reaction and said it was severe enough that she did not feel she could walk to the office on the college campus. I recommended she call her doctor and if she continued to feel severe dizziness go to Emergency Room. I called her back at 4:54 pm on 3/16/21 and she reported she did go to the Emergency Room and they did a CT Scan and also some other tests but she could not remember everything. She said her blood pressure was elevated while in the Emergency Room. Was discharged and has a follow up appointment with her normal provider. Client called on 3/18/21 at 4:46 pm and said the dizziness continued and she was started on a steroid and meclizine by her provider.
61 2021-03-18 chest pain Patient felt gassy with chest pain. History of GERD. Burping a lot during the sensation. Some reprod... Read more
Patient felt gassy with chest pain. History of GERD. Burping a lot during the sensation. Some reproducible L sided chest pain likely radiating from the vaccine site.
61 2021-03-19 chest pain I developed burning across my chest and felt as though I swallowed a golf ball. The burning occurre... Read more
I developed burning across my chest and felt as though I swallowed a golf ball. The burning occurred approximately 30 minutes after injection and the feeling in my throat occurred approximately 1.5 hours later. I called the pharmacy that administered the injection and they advised me to call my physician. Since I had not yet had my first visit with a new primary care physician, I opted to go to the local emergency room later the same evening.
61 2021-03-19 nosebleed I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pai... Read more
I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pain in left arm from shoulder to elbow (injection was in left arm), and nausea. Got up to try to get Tylenol tablets, but returned to bed because I was unsteady on my feet & didn't feel like I should try to go downstairs to get the Tylenol or a thermometer to take my temperature. But my husband said I was warm to touch when he brought me extra blankets to help mitigate persistent chills I was having t/o the night. Symptoms continued until morning of March 20, 2021 and gradually lessened by evening. Stayed in bed all of March 19th and took Tylenol 650mg every 6 hours to lessen bad headache. Ate a few saltine crackers to lessen nausea symptoms & drank ice water. Had a small nosebleed evening of Mar 19th that resolved with pressure to the bridge of my nose. Today (Mar 20th), I have residual light headache that goes away with Tylenol, but no fever, chills, nosebleeds or arm pain.
61 2021-03-19 chest discomfort Pt c/o Right chest tightness, and phlegm in her throat, coughing. Her VS (BP/HR, SBP @ 140-170'a) VS... Read more
Pt c/o Right chest tightness, and phlegm in her throat, coughing. Her VS (BP/HR, SBP @ 140-170'a) VS stable all throughout, sat 100% the whole time. Called Dr., ordered to give Benadryl 25 mg po and Albuterol 2 puffs inhaler. Her symptoms got better, but continued. Called 911 since she's still coughing and continue to have the 'phleghm' like symptoms in her throat.' 911 assessed her and pt refused to go to ER for further treatment, she signed the paper. Sent her home with her husband, and instructed her to call 911 if her symptoms get worst.
61 2021-03-20 nosebleed 1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, starte... Read more
1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.
61 2021-03-21 chest discomfort, chest pain Chest pain/pressure, treated with Aspirin 324 mg PO with no change.
61 2021-03-21 pallor Patient received vaccine then sat in the observation area. I was called over when she looked pale an... Read more
Patient received vaccine then sat in the observation area. I was called over when she looked pale and felt dizzy a few minutes after receiving the vaccine. We took her vitals and her O2 was 98%, HR 61, and BP 92/67. Her normal BP is in the 110s. No history of syncopal episodes or diabetes. Patient then became unresponsive to questions and stared off into the distance for about 10 seconds. She never lost consciousness. She proceeded to gurgle up vomit and I called 911. She became responsive again and able to converse normally, but still felt dizzy. We wheeled her to the front, and EMS arrived. She agreed to go to the hospital due to the concern for her unresponsive episode, inability to walk on her own, and living by herself.
61 2021-03-21 chest pain The Covid Pfizer vaccine was injected into my left arm muscle. On March 3, Wednesday, the day of vac... Read more
The Covid Pfizer vaccine was injected into my left arm muscle. On March 3, Wednesday, the day of vaccine, immediately after injection, I felt numbness/tingling in lips, upper & lower & inside left of head/brain area, and also brief very sharp pains in my upper body randomly throughout my arms and chest. Intermittent sharp pain in center of chest.- scale 2/10 After the first 15 min, I sat outside the tent, and noticed a numbness in my left leg and foot and sharp pain in my left big toe - (03/21/21 left big toenail showed a light discoloration). Symptoms subsided within an hour, yet a residual minor numbness in my lips, continued, and intermittent sharp pain in center of chest. 2/10 On March 7, Sunday following the vaccine, at 11:00 am I felt definite numbness on the left side of my face. I touched it to determine if I could detect a sensation with my fingers, and I felt the numbness as I touched my face as well. My right side of my face was normal. Residual numbness to left face/head intermittently. including today more noticeable March 22, 2021.
61 2021-03-22 chest discomfort After waiting 20 minutes, noted some back pain, tightness; on oxygen at home; cannister almost emp... Read more
After waiting 20 minutes, noted some back pain, tightness; on oxygen at home; cannister almost empty. VSS ; uncertain after called about whether to be evaluated/go home; refused ED at that time. Decided if could get in car comfortably would go home, if not, to ED for evaluation. More chest tightness as tried to get in car, decided to go to ED for evaluation; again called.
61 2021-03-23 chest discomfort About 50 minutes after the vaccine was given, my tongue began to swell and I experienced tightness i... Read more
About 50 minutes after the vaccine was given, my tongue began to swell and I experienced tightness in my throat and chest and shortness of breath. (This was occurring while I was driving myself home from the vaccination site.) I administered my Epipen. And I then drove myself to the Emergency Room, which is near my home. At the ER, I was injected with cortisone, Benadryl, and Pepcid, and had my heart and blood pressure monitored for about 3 hours and then I was released, with a prescription for 50MG Prednisone (1q/day) and 10MG Pepcid (2q/day) x 5 days (for both scripts). I finished the prescriptions, but am still feeling some discomfort in my throat and some dizziness.
61 2021-03-23 hypotension BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; ... Read more
BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.
61 2021-03-23 fainting Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vacci... Read more
Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vaccinated. Felt better the next day, still had slight fever. By Wednesday (third day after vaccine day), felt fine. The reason I am reporting this is the fainting episodes. I do not see that online as a listed common side effect of the vaccine.
61 2021-03-23 heart rate increased Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat bef... Read more
Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat before i got the shot they seem to think my sugar dropped as soon as i had something to eat and drink i was fine
61 2021-03-23 heart rate increased PT RECEIVED THE COVID VACCINATION AND STARTED C/O RAPID HEART BEAT; VACCINE CLINIC OBSERVED PT AND T... Read more
PT RECEIVED THE COVID VACCINATION AND STARTED C/O RAPID HEART BEAT; VACCINE CLINIC OBSERVED PT AND THEN TRANSPORTED HER TO THE ED FOR MONITORING. PT WAS GIVEN IVF AND PLACED ON CARDIAC MONITOR.
61 2021-03-24 chest discomfort Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh... Read more
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
61 2021-03-24 chest pain Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symp... Read more
Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symptoms started 3 days after injection on 03/24/2021. Headache, chills, fatigue, atypical chest pain.
61 2021-03-24 heart rate decreased, hypotension Low BP 74/40, low heart rate- 40, sweating, dizzy, gave ice pack on back of neck and under arms, too... Read more
Low BP 74/40, low heart rate- 40, sweating, dizzy, gave ice pack on back of neck and under arms, took vitals after 10 min again HR 53- BP 82/43, RR 16 96% drank water, 14:55 not dizzy, sitting up, BP 133/82, no sweating, HR 50, RR 16, 99%, 15:00 took to car gave water for way home
61 2021-03-24 heart rate increased On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 10... Read more
On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.
61 2021-03-24 chest pain Patient came in received second dose Pfizer vaccine at 3:00pm and reported she had burning sensation... Read more
Patient came in received second dose Pfizer vaccine at 3:00pm and reported she had burning sensation in top of mouth, throat, chest area at 15:03. Patient stated this reaction had also occured after first dose and lasted 3 days. Patient vitals were 99% O2, pulse 82, BP 122/82, Resp. 18 at time of reaction. Patient has no s/s of shortness of breath, n/v, dizziness, swelling, hives. Patient was given 25mg of PO diphenhydramine and monitored for 30minutes. No increase in symptoms. Patient left with symptoms starting to resolved. Patient educated by provider on site to take famotidine and continue diphenhydramine PO as needed every 4-6 hours. If s/s increase to report to the emergency department.
61 2021-03-25 deep vein blood clot 3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed lat... Read more
3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed later on to shortness of breath after a week.
61 2021-03-25 chest pain Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the che... Read more
Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.
61 2021-03-25 blood pressure increased Lip Tingling and Minor Swelling started approximately 5 min after shot Tongue Tingling and Minor Sw... Read more
Lip Tingling and Minor Swelling started approximately 5 min after shot Tongue Tingling and Minor Swelling started approximately 5 min after shot Blood Pressure increase to over 200/100 - taken approx 10 min after shot and then 15 min after shot, at approx 25 min after shot was down to approximately 160/90
61 2021-03-25 fast heart rate Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for C... Read more
Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1. She developed itching in there throat within 30 minute waiting period. She was taken to Rapid Response Room. Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes. Then dry cough. No nausea, no vomiting, no light headed feeling. No facial swelling No hives. OBJECTIVE: Vitals - 154/97, 105, 100%RA Neck - Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing. Speaking full sentences. Assessment/ Plan: Anaphylaxis to Covid-19 Vaccine: - emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am Vitals stable entire time (see midas report) EMS arrived to transport to local hospital.
61 2021-03-25 blood pressure increased Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site... Read more
Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site no redness, warmth. Patient expressed both parents recently passed away and expressed increased anxiety. Pt walked to the car, steady and stable. Pt will take tylenol as prescribed, rest, and hydrate. Recommend pt to follow-up with PCP on Monday for anxiety and elevated BPs. Pt denied HTN. Vitals: At 13:25, 160/82. 1 minute after 99 At 13:45, 160/82, 98HR, 99% spo2.
61 2021-03-25 fainting syncope, n/v
61 2021-03-26 heart flutter, hypertension PATIENT STATES FEELS LIGHTHEADED AND HEART FLUTTERING. VITALS ARE BP 185/90, HR 103, RESP 20 AND O2 ... Read more
PATIENT STATES FEELS LIGHTHEADED AND HEART FLUTTERING. VITALS ARE BP 185/90, HR 103, RESP 20 AND O2 SAT 0F100%. MONITOR STRIP DONE WITHA HR OF 112 AND REGULAR. PATIENT MONITORED ANOTHER 15 MINS WITH HR OF 90 AND REGULAR. PATIENT ISTRUCTED TO GOTO EMERGENCY CLINIC IF SYMPTOMS RETURN.
61 2021-03-26 fainting Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p... Read more
Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.
61 2021-03-27 blood pressure fluctuation, palpitations, heart rate increased 3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high ... Read more
3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high heart rate, blood pressure high and low, chills, weak, diarrhea, nausea, headache 3/19-3/23/21 - heart issues better, still had flu symptoms Propanolol and Alprazolam for heart palpitations. ER visit 3/16 - recv IV's, all labs normal. PCP visit 3/23.
61 2021-03-27 palpitations, chest pain at 3am I woke up with a racing heart rate and mild burning in my belly. I couldnt go back to sleep. ... Read more
at 3am I woke up with a racing heart rate and mild burning in my belly. I couldnt go back to sleep. The next day the burning in the belly got worse. My stomach became bloated and I was having shortness of breath walking short distances. The racing heart and chest pain ebbed and flowed. I made a video appointment with my PCP group on Thursday and they prescribed omeprazole and asked me to come in for physical exam the next day. When I went in the symptoms persisted, they did blood work, did a chest x-ray and sent me over to the emergency room. At the ER they did an EKG, more blood tests and recommended I have a abdominal CT on an outpatient basis. They couldnt say my symptoms were a result of the Pfizer shot but they could not rule it out that it was related to the shot.
61 2021-03-28 chest pain Pt c/o chest pain 20 min after vaccine. Pain in middle of chest, dull quality. Asked pt if she wante... Read more
Pt c/o chest pain 20 min after vaccine. Pain in middle of chest, dull quality. Asked pt if she wanted to be seen by ED, and she agreed. Pt wanted to walk, so staff assisted patient to ED. After arrival ro ED, pt stated chest pain resolved. pt was checked in to be further evaluated. Pfizer dose #1. Lot EN6198 Exp 6/30/21.
61 2021-03-29 chest discomfort Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt li... Read more
Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".
61 2021-03-30 chest pain violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous... Read more
violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 14:00 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The patient had known allergies to flu shot, contrast dye, aspirin and codeine. She had a major reaction to flu shot so was scared to have this. She took Pepcid and Zyrtec 3 days prior and 1 week following. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. There were no other vaccine in four weeks. There were other medications in two weeks. The patient received the first shot, day 1 and 2 was fine. On day 3 (09Mar2021 11:00), diarrhea started, day 4 (10Mar2021) - violent heavying, sweating for 2 hours then pain in chest. The patient thought she was having a heart attack. After many test it was not her heart, then more test that would not cause these issues. The physician determined it was the vaccine. On Mar2021, she still feel chills and very sore. The patient was scared to get her second dose. It was unknown if the patient received treatment for the reported events. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not tested post vaccination. The outcome of the events was unknown. Information on the lot/ batch number has been requested.
61 2021-04-06 atrial fibrillation AFib; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-year-old... Read more
AFib; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right arm, on 15Mar2021 at 14:00 (02:00 PM), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. One week after the vaccine on 22Mar2021 at 09:00 AM, the patient had an atrial fibrillation (Afib) event. On 22Mar2021, the patient went to the emergency room (ER) or department or urgent care and ran tests including electrocardiogram (EKG), chest X-ray, and blood work which were all normal. Now, the patient had to go to a cardiologist for further understanding of the reason for AFib event. No treatment was given for the event. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the event. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
61 2021-04-08 palpitations racing heartbeat, breathlessness, coughing, nausea
61 2021-04-10 ischaemic stroke, blood pressure increased, cerebrovascular accident I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood press... Read more
I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before. I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
61 2021-04-11 heart rate increased, blood pressure increased, chest discomfort Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard... Read more
Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.
61 2021-04-12 cardiac arrest Witnessed cardiac arrest with death as the outcome
61 2021-04-13 nosebleed, blood clot, platelet count decreased, cerebral haemorrhage 4/9/21-30 minutes to 1 hour after receiving 2nd dose of vaccine patient had bloody nose, clots, with... Read more
4/9/21-30 minutes to 1 hour after receiving 2nd dose of vaccine patient had bloody nose, clots, with bleeding sores on tongue and side of mouth. Began to have bruises on arms, feet and legs. Blood in urine and bruises on back. Presented to emergency department on 4/11/21. CT brain revealed a right sided posterior temporal hemorrhage. Patient was emergently treated with platelets, DDAVP, factor VII, Decadron, IVIG. 4/12/21, patient denies headache, changes in vision, double vision, change in sensation, including burning, pinprick, numbness, no focal or motor weakness. No change in bowel or bladder control. No sensory changes. Patient states she is now back to her normal state of health, save for the bruising described.
61 2021-04-13 blood glucose increased, skin turning blue Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills... Read more
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
61 2021-04-14 chest pain, chest discomfort At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin ... Read more
At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.
61 2021-04-14 palpitations dizzy, weak, stomach pain, loose bowel movements, confusion, heart palpitations
61 2021-04-17 fainting Extreme weakness & Fatique Dizziness Fainting Death 04/09/2021
61 2021-04-17 heart flutter, heart rate increased My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super water... Read more
My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
61 2021-04-17 fainting dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache;... Read more
dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
61 2021-04-18 hypertension, chest pain, fibrin d dimer increased Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and should... Read more
Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and shoulder pain lasting more than 2 days; high BP; fluid around heart; elevated D DIM; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer BioNTech, lot: EN6199) in left arm on 06Apr2021 06:30 PM at a single dose for COVID-19 immunization. Facility type vaccine was Pharmacy or Drug Store. Medical history was not reported. Patient was not pregnant (AS REPORTED) at the time of vaccination. Concomitant medications were unspecified. No other vaccine in four weeks. Other medications in two weeks was yes. Patient used to receive Wellbutrin and experienced allergies. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: ER8733) in left arm on 17Mar2021 05:00 PM at a single dose for COVID-19 immunization. Patient experienced severe left chest back and shoulder pain lasting more than 2 days accompanied by high blood pressure (BP), fluid around heart and elevated D DIM on 07Apr2021 05:30 AM. Adverse events (AE) resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The outcome of the events was recovering. AE treatment: Ultrasound, CT Scan, morphine. If COVID prior vaccination was no. If COVID tested post vaccination was no.
61 2021-04-18 heart rate abnormal anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely r... Read more
anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.
61 2021-04-18 cerebrovascular accident having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, lef... Read more
having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
61 2021-04-18 fast heart rate tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light a... Read more
tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.
61 2021-04-20 blood pressure decreased, heart rate increased severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started... Read more
severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.
61 2021-04-24 platelet count decreased Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating... Read more
Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating pain/shoulder pain/given high on the top of her shoulder. It hurt; sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 61-years old via an unspecified route of administration on 19Mar2021 10:10 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included systemic lupus erythematosus from 1985 and ongoing, arthritis and osteoarthritis from an unknown date and unknown if ongoing (She has osteoarthrosis throughout her body and her feet). Family history included stroke (husband died at the age of 59, he was having stroke upon stroke). The patient's concomitant medications were not reported. It was reported that when she received the shot, it was given high on the top of her shoulder and it hurt. She could not move her arm for 3 days. The pain was excruciating. On the 4th day, her arm was sore, but she could move it. She had no fevers, she didn't get sick, but she just couldn't move her arm. The shot was given at at 10:10 am, and by noon she could barely move her arm. Her left side of the mouth doesn't want to work properly. Her Bells Palsy started on 05Apr2021. She was in her car and driving to the store, when all of a sudden her left eye was watering. She got home and she didn't see anything wrong with her eye, except it was watering. She could tell a difference between the left and right side of face when she touched it. Something was wrong with her right side. Her eye was not opening all the way, it's been dropping, and her lip was down. She can't smile, and when she drinks water it's comes out. The patient clarified that it was her left side that is drooping. She went to the emergency room due to Bell's palsy. She could not move her arm within 2 hours of getting the shot. The patient mentioned her whole body aches from the Lupus and arthritis, but the shoulder pain was different after the vaccine. The shot itself hurt, and she thinks the one who administered the vaccine might have hit something. There's not a day that doesn't go by that she is not in pain. Her platelets are 200, which is very low. The patient underwent lab tests and procedures which included activated partial thromboplastin time: unknown result, blood glucose: unknown result, computerised tomogram: unknown result, full blood count: unknown result, glomerular filtration rate: unknown result; all on 06Apr2021, magnetic resonance imaging: showed a darkened area in her brain that looks like its connected with Bells Palsy on an unspecified date, basic metabolic panel: unknown result on 06Apr2021, platelet count: her platelets are 200, which is very low on an unspecified date, prothrombin time: unknown result, troponin i: unknown result (High sensitive ); both on 06Apr2021. The patient did not recover from Bell's palsy, recovered from vaccination site pain on 23Mar2021, from sore arm on 19Mar2021 and the outcome of the remaining event was unknown. Information about Lot/batch number is requested.
61 2021-04-24 palpitations, fainting, blood pressure increased, chest pain, heart rate increased felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Heada... Read more
felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.
61 2021-04-24 cerebrovascular accident she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hur... Read more
she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hurts a couple of days ago; Her hand is now cramped up, and she cannot bend it, almost like someone who has cerebral palsy.; she could not use her left hand; Her hand is now cramped up, and she can not bend it, almost like someone who has cerebral palsy./all her fingers are cramped and she cant open them and her hand is in a brace; radial nerve palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administration in left arm on 19Mar2021 as SINGLE DOSE for covid-19 immunization. Medical history was not reported. There were no concomitant medications. On 01Apr2021, she woke up and her left hand and arm were numb. She went to the hospital, and they told her she could have partially and had a stroke. Three days after receiving the first dose of the Covid vaccine, she could not use her left hand. Her hand was now cramped up, and she could not bend it, almost like someone who had cerebral palsy. She stated that after the first dose her left hand went numb, and she went to the hospital and was diagnosed with radial nerve palsy. She stated that all her fingers are cramped, and she can't open them, and her hand was in a brace. She stated that she would have to do physical therapy. It was her left hand, the same arm that she got the first dose of the Covid vaccine in. She could not move her left hand. She was really annoyed about it, and she was scared. The patient stated that she had a grandson and a daughter. This vaccine was the best possible way to prevent Covid. She had always got vaccines. Upon follow-up received on 09Apr2021, she was calling about the Pfizer Covid vaccine. She does not have a ride to get her second dose of the Covid vaccine on Saturday morning. She does not know the name of the facility where she was supposed to go. She was asking for help with an (cab service). She thought she was calling her county. She would call her county and ask for help with a ride. She had a reaction after her first dose of the Covid vaccine. She received the first dose on 19Mar2021. She does not know if it was because of the Covid vaccine. She was asking if she should get the second dose of the Covid vaccine in the same arm as last time. She wanted to get the second dose of the Covid vaccine in the same arm as last time, so that she does not mess up the other side of her body. She was asking what was going on with her arm. She was asking if thaws had anything to do with the Covid vaccine. Upon follow-up received on 09Apr2021, she scheduled second dose due on 10Apr. Her left arm hurts a couple of days ago, it ended her going to the hospital. She called to ask if it had something to do with the Covid vaccine. The event hypoaesthesia, cerebral palsy, muscular weakness, muscle spasms outcome was reported as not recovered. The event cerebrovascular accident, pain in extremity, radial nerve palsy outcome was reported as Unknown. The action taken in response to the events for bnt162b2 was not applicable. Therapeutic measures were taken as a result of her hand was now cramped up, and she cannot bend it, almost like someone who had cerebral palsy. (cerebral palsy). Follow-up (09Apr2021): This follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: New significant information.
61 2021-04-27 low platelet count thrombocytopenia; Heavy blood in the stool; This is a spontaneous report from a contactable consumer... Read more
thrombocytopenia; Heavy blood in the stool; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (Lot Number: EN6148), via an unspecified route of administration in arm left on 21Mar2021 as single dose for COVID-19 immunisation. Medical history was none. No known allergies. The pateint was not pregnant. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 28Feb2021 for COVID-19 immunisation. No other vaccine in four weeks. No ther medications in two weeks. The patient experienced Heavy blood in the stool, thrombocytopenia on 07Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No treatment received. No covid prior vaccination. No covid tested post vaccination. No covid tested post vaccination. The outcome of events was not recovered.
61 2021-04-28 blood clot Blood clots in colon; 2nd dose 07Jan2021; This is a spontaneous report from a contactable other hcp ... Read more
Blood clots in colon; 2nd dose 07Jan2021; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19), second dose at the age of 61-years-old via an unspecified route of administration, administered in arm left on 07Jan2021 (Batch/Lot Number: Ek5730) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient has no known allergies. Concomitant medication included unspecified medication. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm on 22Dec2020 (lot number: Ek5730) at the age of 61-years-old for covid-19 immunisation. The patient experienced blood clots in colon on 14Jan2021. It was noted that the patient received the second dose on 07Jan2021. The patient was hospitalized for blood clots in colon for 30 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Jan2021. Therapeutic measures were taken as a result of blood clots in colon which included surgery. The patient was recovering from the event.; Sender's Comments: Based on event-vaccine chronological association a causal relationship between event blood clots in colon and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
61 2021-04-28 chest pain, loss of consciousness, blood pressure increased passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left ... Read more
passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left pinky and ring fingers felt nerve tingling sensations; then the back of her throat had a chemical taste and tingling; then the back of her throat had a chemical taste and tingling; BP was 164/94 while lying down; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; tongue was tingling and felt swollen with an altered chemical taste for 2 days; tongue was tingling and felt swollen with an altered chemical taste for 2 days; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 (Lot Number: ER8734) at the age of 61 years old as single dose for covid-19 immunisation. Medical history included Low thyroid, kidney infections, skin rashes, high cholesterol, food sensitivities. Concomitant medications in two weeks included liothyronine sodium (CYTOMEL); levothyroxine; vitamin b complex (VITAMIN B); levoglutamide (L GLUTAMINE). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. On 12Apr2021 11:00, within 1st min of vaccine, the patient's left arm was tingling, then the back of her throat had a chemical taste and tingling, then tunnel vision, then that was the last thing she remembered until she heard her partner saying, "Are you ok?" The patient said to her she thought she fell asleep. She was an RN and said that the patient passed out for about 15 seconds and had "jerking movements" of her upper extremities before she woke up. The staff and medic helped the patient to the floor where she rested for 20 min with her legs elevated on chair. BP was 164/94 while lying down, pulse was 74. The patient returned home and continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder for most of the day. Also her left pinky and ring fingers felt nerve tingling sensations for the rest of the day. Her tongue was tingling and felt swollen with an altered chemical taste for 2 days. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
61 2021-04-30 palpitations, loss of consciousness heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a sponta... Read more
heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.
61 2021-05-03 loss of consciousness Every time she bends over, if her head gets below her shoulders to pick something up she will black ... Read more
Every time she bends over, if her head gets below her shoulders to pick something up she will black out; fever; everything in her body ached; vertigo; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 26Mar2021 10:00 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as single dose at age of 61-year-old for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medications included methotrexate; hydroxychloroquine. Adverse event following prior vaccinations violently ill from flu shot, ended up in urgent care, 20 years. The patient experienced every time she bends over, if her head gets below her shoulders to pick something up she will black out, fever, everything in her body ached, vertigo on an unspecified date in 2021. Clinical course: The first Covid 19 vaccine she ran a fever and everything in her body ached. Every time she bends over, if her head gets below her shoulders to pick something up she will black out. She reports she has blacked out in the shower and blacked out from leaning off the sofa to pet her dog. She almost went into her coffee table trying to pet her dog. This lasted for about 5 days after she received her first Covid 19 vaccine. After about 5 days it cleared up and went away. She called the facility that gave her the Covid 19 vaccine, a drive thru facility and they told her she had vertigo. She knows she didn't have vertigo because she didn't have these problems until after she received the Covid 19 vaccines. Outcome of event black out was recovered in 2021, and outcome of other events was unknown.
61 2021-05-06 blood pressure increased Headache. Denies c/p, swelling, itching. Extended observation. BPs 173/88 (HR 89), 181/87 (HR 86), O... Read more
Headache. Denies c/p, swelling, itching. Extended observation. BPs 173/88 (HR 89), 181/87 (HR 86), O2 100%. Stable gait w/one person assist. Stable and released.
61 2021-05-07 low blood oxigenation Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the bac... Read more
Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.
61 2021-05-09 atrial fibrillation Patient developed paroxysmal atrial fibrillation. Upon date of death- pt husband reported SOB, incon... Read more
Patient developed paroxysmal atrial fibrillation. Upon date of death- pt husband reported SOB, incontinence, gasping for air, slumped forward and died upon 911 arrival.
61 2021-05-10 haemoglobin decreased, platelet count decreased, low blood platelet count 61 Year old female presented with shortness of breath and was found to have a platelet count of 11 k... Read more
61 Year old female presented with shortness of breath and was found to have a platelet count of 11 k/ul ( She had a platelet count of 184 k/ul 12 days prior). She received 2nd dose of Pfizer vaccine 21 days prior to the event. She received steroids with improvement in platelet count.A diagnosis of immune thrombocytopenia ( non thrombotic) was made.
61 2021-05-13 heart rate increased, chest pain, blood pressure increased, palpitations By 12:50 hands were starting to swell; chest pain; heart palpitations; pulse felt like her heart was... Read more
By 12:50 hands were starting to swell; chest pain; heart palpitations; pulse felt like her heart was racing very hard; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; blood pressure was up; throat felt like it was starting to tighten; eyes itchy; eyes itching much worse; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date: unknown), via an unspecified route of administration in left upper arm on 22Apr2021 12:10 (at the age of 61-year-old) as unknown single for COVID-19 immunization. This report was not related to a study or programme. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse events following prior vaccinations was first time had flu shot made her very ill, next year doctor suggested she should just have half of a shot instead of full shot to see if she tolerated it and she was able to tolerate that. She had not any other problems with flu vaccines in general. Some of the other vaccines, she was just supposed to take Benadryl with them because of some of the filler ingredients people put in things. She had previously had the 1 dose shingles vaccine, but she had gotten probably shingles probably a couple of months after that so they encouraged her to get the 2 part shingles vaccine at a later date and told her to do the pre-medicate routine like Benadryl day before, day of and at least 2 days after shingles vaccine doses and if any major problems call for help. She did not have a noticeable problem from the 2 part shingles vaccine. Some of the times depends on what filler ingredients people use. She was allergic to nutmeg which was used as an emollient oil or it's called Myristicin something or other oil; if something has too high a dose of mannitol it can cause a problem. She has a very long list of allergies and high sensitivities; if it was a high enough sensitivity it goes in allergies list, even though it may not be a true allergy. Family has lots of allergies. Regarding prescribed indication additional details: She had 3 doctors who initially advised her to get the vaccine including her primary care physician, oncologist and haematologist; this was because she was a high risk person because of various health issues. Her haematologist 2-3 months ago when she had her last appointment with him he was saying to get the shot and prescribed the epi-pen at that time; no one was having it yet, but he expected she would have some sort of reaction to it not able to be covered by Benadryl alone. Medical history included ongoing platelet disorder Verbatim: Unidentified platelet disorder, Lots of allergies, cardiac murmur, ongoing asthma, osteoarthritis, glucose tolerance impaired, hypoglycaemia slow thyroid and back and neck pain. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for hypersensitivity (50mg taken as needed), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for hypersensitivity (10mg daily), fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma (250/50 twice daily), levothyroxine sodium (SYNTHROID) taken for hypothyroidism (137mcg-1 tablet daily), methylphenidate hydrochloride (RITALIN) (20mg tablet twice daily), salsalate, colestyramine (QUESTRAN LIGHT) (2-500mg tablets 3 times daily), sucralfate (CARAFATE) (1mg tablet 4 times daily-dosage verified with caller as milligrams and captured as provided), loperamide hydrochloride (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) (2.5/0.25 takes 2 tablets of that 4 times daily), calcium carbonate (CALCIUM OYSTER SHELL [CALCIUM CARBONATE]) (Alternates dose of 500mg and 1000mg on days takes Vitamin D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) (250 mg), vitamin D (50,000 units every other day taken), vitamin B12 (1mg injection every 14 days), clonazepam (KLONOPIN) (2-1mg tablets at bedtime), montelukast sodium (SINGULAIR) taken for asthma (10mg tablets at bedtime) and cefixime (FLEXERIL [CEFIXIME]) taken for back pain, neck pain (10mg tablets 3 times daily as needed). On 22Apr2021, Onset time: She had a note saying her eyes itchy at 12:20, but they were itching before that because she waited long enough to report it; so onset time was less than 10 minutes when her eyes started itching. Then her pulse; she could feel chest pain; heart palpitations; pulse felt like her heart was racing very hard. They did check her pulse while she was in their initial observation and her pulse was only in the 70s, but oxygenation was at 96%.When at doctors office less than 1 hour before that reading, oxygenation was at 98%.Recorded at 12:30 eyes itching much worse, throat felt like it was starting to tighten, heart felt like it was starting to race. By 12:50 hands were starting to swell. She had already been pre-medicated with Benadryl before this before she went down to get the Pfizer Covid-19 Vaccine, she had Benadryl in her system. She had that same morning with her morning meds had taken Zyrtec and Benadryl in anticipation of getting the possibility of getting the Pfizer Covid-19 Vaccine because she has to pre-medicate for vaccines just in case she starts to react in anyway. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines was not administered on same date of the Pfizer Suspect. Emergency Room taken from the location where vaccine administered-they gave her Pfizer Covid-19 Vaccine shot had her sit for basic observation then sit for extended observation. In that time period telling them her symptoms were going on, increasing. They gave her another 50mg Benadryl even though she had already had 1 before and then called emergency room, took her down, left her in waiting area even though she had heart and chest palpitations. Physician Office seen prior to event on 20Apr2021, seen after event 27Apr2021. Primary Care Physician didn't hear anything in lungs either visit. Not admitted to hospital; seen in emergency room, theoretically she got treated; however her basic blood pressure and stuff even with what they were doing was higher than when she was triaged in the ER; blood pressure was up and something else,oxygenation level moderately reduced from when she came down to when she was just let go; however her symptoms were worse when she was leaving than when she got there. She knows what they gave her while she was there was IV of normal saline, solumedrol and IV Benadryl. Thinks they later gave her Tylenol tablets. Finally got them to do an EKG because kept saying her chest was getting worse but that was several hours after she was back there even though came there having chest pains. In her opinion this hospital was not taking reaction seriously. Not admitted to hospital even though symptoms were worse and blood pressure higher on discharge, well above her normal levels. Currently trying to get them to explain why they took so long to do anything for her. Finally did a chest x-ray on 22Apr2021:discharge papers say abnormal x-ray and they gave a couple of different possibilities as to what that might be so Primary Care Physician wrote a prescription to get a follow-up chest x-ray to make sure that everything is fine and back to normal and not ongoing or progressing or anything because they gave some strange things: what their impressions were: findings: there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. It says the left lung appears clear; cardiomediastinal silhouette is within normal limits; impression restates non specific right findings there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. This was from front and lateral views of the chest x-ray at 19:00pm 22Apr2021. 2 ECGs: She guesses this is what they call EKG not, relevant point is that in the notes there for the records: Says abnormal ECG compared with blah blah blah, hard to find when exactly they wrote this, trying to get the exact wording for each of the two. Machine results CED, which caller explained is what they call themselves now instead of ER, notes for MD interpretation; one done at 17:53 , other at 21:32. They both say there was slightly different readings, however both say abnormal ECG. One of the wordings that is in both. She had no further details to provide regarding relevant testing/investigations. She had to be in the ER back in the room for several hours before they would do the EKG and that's only because she said I have chest pain and standard procedure is to do an EKG, had been back there for hours, they had done no tests, the only thing they did was basic blood panel, had not done a troponin or heart enzymes test, had not done EKG that's why she knows they were not taking her seriously at all; if someone says chest pains and you don't do anything in the standard protocol they are not taking you seriously. On this Monday, 2 days ago she had gone down to pick up the records from the ER to go to Primary Care Physician appointment 27Apr2021, finally actually got to speak to someone who said they would get back to her on 27Apr2021 to look into why the EKG tests were not done for someone having chest pains. That's one of the first things you do for someone having chest pain, no matter what the source. Frustrated with them because they're still not communicating back, they had not taken her seriously while she was there; unknown if they were actually going to be reporting, as they were still trying to convince her to get the second dose of Pfizer Covid-19 Vaccine. If she reacted to the first dose in first 10 minutes, second dose could be much more of a reaction. With the amount of anti-histamines in her system with Benadryl and Zyrtec and she was still starting to react in under 10 minutes. It's possible to be one of the inactive ingredients but she doesn't see anything in the pamphlet provided that she could identify at first glance as being the culprit to the problem other than 2 possibilities: potassium chloride and other is monobasic potassium phosphate. There is a possibility of her having a reaction to those because she was known to react to certain potassium products; sometimes it was the inactive ingredients. She definitely would have wanted to get the second part of the Pfizer Covid-19 Vaccine series until after she was not getting the medical attention she needed after reaction to the first dose. Because ideally you're supposed to have it at the same location, that just made her very nervous at the prospect of worse reaction at location that did not take her serious the first time. She was a big fan of Pfizer thought they do a great job; she had not known it was a 2 parter, not that it should make much difference. When her Primary Care Physician was saying second dose of Pfizer Covid-19 Vaccine was out of the question and she had been saying to people that she did not think it would be prudent to take the second part, they kept trying to say oh you need to get the second part, talk to so and so so they can convince you to get it, and doctor is going no. She reacted to ringers lactate or lactated ringers whatever the name is, her retired nurse sister sat and watched her getting some ringers lactate prior to surgery for her tear duct and saw her starting to break out in red splotches, patient said she was itching. Action taken in response to the events was drug withdrawn. The outcome of the events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
62 2020-12-31 chest discomfort REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77... Read more
REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77. 25MG BENADRYL GIVEN.
62 2021-01-02 heart rate increased Within minutes of receiving the injection I began to feel dizzy, a nursing provider took my bp appro... Read more
Within minutes of receiving the injection I began to feel dizzy, a nursing provider took my bp approx 5-6 min after receiving the vaccination with a wrist cuff and it was 191/125 , she obtained a manual cuff and took it about 3- 5 min after the initial bp and it was 180/100. I felt more dizzy and laid down. I also had a rapid HR but did not take my pulse. The dizziness fluctuated and gradually cleared over 20-30 min. A third bp was 146/84 and a last bp approx 30min after the injection was 124/76 and I felt well enough to get up and walk.
62 2021-01-04 heart rate increased fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore ... Read more
fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore arm /arm soreness; tired; felt like she had a flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included Diabetes, allergies, heart (Heart disorder). Concomitant medications included irbesartan (AVAPRO) for heart, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies, metoprolol for heart, metformin for Diabetes, all were ongoing. The patient (Hospital scheduler/employee) had been experiencing side effects of the vaccine. She took the vaccine on 18Dec2020 and still experiencing nausea, headaches, and chills. She asked how long she would experience these side effects and if she needed to take anything. Patient reported she was exposed to someone who had COVID, her son's girlfriend had direct exposure to COVID and wanted to know how it would affect her. The patient further stated she was a hospital scheduler, she had the Pfizer Covid vaccine on 18Dec2020. She had a sore arm/arm soreness and was tired immediately after (18Dec2020), stated by Saturday 19Dec2020, she started having a low-grade fever, chills, headache, nausea, and still had the soreness in the arm. This went on for 2-3 days. Patient stated that up until now, she still had nauseous feeling that happened intermittently around early morning or mid-day, the chills were midday to early evening, it was like she didn't feel good, had to leave early from work. The fever only lasted a couple of days. She also had one isolated episode of fast heart rate that woke her up in the early hours of Sunday 20Dec2020. Caller stated she expected some of these effects to only last a couple of days but wanted to know if this was normal. She tried working 2 days last week and by mid-day she was just really tired, like she was about to get the flu, she felt like she had a flu just with no respiratory symptoms (De2020). She knew of one other coworker who was experiencing similar symptoms. No patient identifiers were provided, no further information provided. Patient did have history of allergies from when she was a child and was on medication, she was on over the counter medication Zyrtec for years, she didn't know if there could be a conflict between them. She received her vaccine part of the hospital. She also called because her son and his girlfriend live in her house and his girlfriend was exposed to someone who tested positive for Covid, she wanted to know how this may affect her since she had the vaccine. Investigation assessment was no. The outcome of the event "sore arm /arm soreness" was recovered in Dec2020, of "low grade fever" was recovered on 21Dec2020, of the events "tired", "nausea", "headache" and "chills" was not recovered, of the other events was unknown. Information about Lot/Batch number has been requested.
62 2021-01-05 fainting Syncope
62 2021-01-07 atrial fibrillation Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She ha... Read more
Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She has not had history of reaction before. Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing. She has a history of afib and last night she had two runs of it and took metoprolol.
62 2021-01-07 fast heart rate Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observatio... Read more
Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA
62 2021-01-10 heart rate increased RAPID HEART RATE 140- 150 NO OTHER SYMPTOMS.
62 2021-01-11 pallor Approximately 20 minutes after vaccine administration, patient reported feeling swelling of throat a... Read more
Approximately 20 minutes after vaccine administration, patient reported feeling swelling of throat and tonsils. Patient did sip water and was verbally communicative and was texting on phone with pale, anxious appearance with not obvious shortness of breath noted. 911 was called to Center per vaccine clinic protocol at which ems initiated IV and took patient to ED.
62 2021-01-11 chest discomfort, atrial fibrillation Atrial fibrillation; Was not feeling well; Warm sensation in chest; This is a spontaneous report fro... Read more
Atrial fibrillation; Was not feeling well; Warm sensation in chest; This is a spontaneous report from a contactable nurse (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EJ 1685), intramuscular, on 21Dec2020 at 09:30 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 62-years-old. The patient received also varicella zoster vaccine RGE (CHO) (SHINGRIX) on 19Nov2020. Medical history included gastrooesophageal reflux disease (GERD) and high cholesterol. Concomitant medications included omeprazole, colestyramine (QUESTRAN), and vitamins. On 22Dec2020, the patient was not feeling well intermittently starting the day after the injection with warm sensation in chest that would go away until 31Dec2020 when the warm sensation of chest would not go away. The patient was sent for EKG that showed atrial fibrillation that she is now being treated for. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. Outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported atrial fibrillation and the administration of COVID 19 vaccine, BNT162B2. More information regarding the clinical course, the patient's underlying concurrent medical condition are required for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
62 2021-01-11 lightheadedness Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately... Read more
Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately 21 hours after injection
62 2021-01-11 heart rate increased, heart rate increased, fainting, chest discomfort, chest discomfort, fainting During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation are... Read more
During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation area, waited approximately 15 mins and then reported chest tightness, dizziness, rash and itching on her arms, fast heart rate, watery eyes, runny nose, and throat irritant. Vitals were obtained and pt was requested to wait another 15 mins for monitoring. During monitoring period, patient became to complain of increased throat irritation and new tongue swelling. Response team was contacted. During reassessment patient's symptoms decreased. Team decided patient was stable and did not require transport to the ED. Patient was monitored for another 15-20 minutes with symptoms resolving. Patient was advised to discuss reaction with her PCP prior to getting second dose of the vaccine.
62 2021-01-11 heart rate increased, loss of consciousness Felt faint, sat down with loss of consciousness for seconds x 2 ,estimated . She felt her heart rate... Read more
Felt faint, sat down with loss of consciousness for seconds x 2 ,estimated . She felt her heart rate was fast. B/P 98/48 - 87/40 HR 92 weak , per pt.
62 2021-01-11 heart rate increased Swollen lips, increased heart rate, temp at 101
62 2021-01-11 lightheadedness became hot and dizzy and stated she had some facial pain. further assessment determined the respons... Read more
became hot and dizzy and stated she had some facial pain. further assessment determined the response to be a vasovagal response.
62 2021-01-11 haemoglobin decreased, anaemia new onset anemia
62 2021-01-12 blood pressure increased, heart rate increased Day after receiving vaccine: fatigue, fever, headache, body aches, shortness of breath, Two days af... Read more
Day after receiving vaccine: fatigue, fever, headache, body aches, shortness of breath, Two days after receiving vaccine: extreme fatigue, racing pulse, high blood pressure
62 2021-01-12 hypertension, palpitations Dizziness, Headache, Palpitations, HYPERtension, anxiety and stated SOB Narrative:
62 2021-01-12 blood pressure increased Tight sensation in her throat, tongue felt tingling. Temp increased to 99, blood pressure increased... Read more
Tight sensation in her throat, tongue felt tingling. Temp increased to 99, blood pressure increased to 179/99
62 2021-01-13 fast heart rate 0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. E... Read more
0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. EMS ON SITE. VS: 168/71, p: 58; 97% O2 SAT R.A.; 0954: BP: 168/71, P: 58, 98% 02 SAT R.A. 1015: LEFT AND WENT TO HOSPITAL. ALERT, ORIENTED
62 2021-01-13 chest discomfort WARM FEELING IN CHEST AND THROAT DENIES ANY DIFFICULY SWALLOWING. HAPPENED 5 MINUTES AFTER INJECT. B... Read more
WARM FEELING IN CHEST AND THROAT DENIES ANY DIFFICULY SWALLOWING. HAPPENED 5 MINUTES AFTER INJECT. BP RANGING 140/60, O2 100. OBSERVED FOR 25 MINUTES. SYMPTONS REMAINS THE SAME SENT TO ER FOR FURTHER OBSERVATION.
62 2021-01-14 fainting, hypertension As per Emergency Dept note of 23 Dec 2020: "Syncope, related to getting the vaccine. Normal ECG, no... Read more
As per Emergency Dept note of 23 Dec 2020: "Syncope, related to getting the vaccine. Normal ECG, no evidence of arrhythmia, normal H/H, no evidence of ACS, CHF clinically. Normal nonfocal exam. Symptoms resolved. Home with reassurance." As per follow-up note of 04 Jan 2021: "62yo female s/p first dose of Pfizer-BioNTech vaccine on 12/23/2020 who experienced syncope, hypertension (200/100) within minutes after receiving the vaccine. She was then transported to the ED where she was given IV fluids, anti-emetic and discharged a few hours later. She reports the onset of fever, chills, anorexia, malaise, and emesis 4 hours after receiving the vaccine. The malaise, chills and anorexia persisted for 4 days at which point she started feeling better. COVID test was reportedly negative. She wants to decline 2nd dose of vaccine."
62 2021-01-14 chest pain, excessive bleeding Pt had 3 vessel CABG on 1/14/21 after presenting to ED with chest pain on 1/9/21. Pt is critically ... Read more
Pt had 3 vessel CABG on 1/14/21 after presenting to ED with chest pain on 1/9/21. Pt is critically ill following OR after cardiogenic shock, bleeding. Requiring inotropes and Impella.
62 2021-01-14 heart rate increased Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due t... Read more
Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due to heart rate.
62 2021-01-14 blood clot She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that e... Read more
She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that evening and started having severe pain in calf of her left leg no redness ,no heat, just hurt to work 1/8/2021 She had surgery on her left leg. 2nd Covid Vaccine received on 1/12/2021 She said she had PT on her right leg with severe pain in her left calf She said she did not have any therapy on her left leg. Two ? three hours later she developed chills, temp 100.1 took temp again later is was 99. She had ultrasound that showed a large blood clot She said the PA told her the blood clot could be from receiving the Covid vaccine
62 2021-01-17 palpitations Patient experience heart palpitations and was experiencing anxiety before and during vaccination. Af... Read more
Patient experience heart palpitations and was experiencing anxiety before and during vaccination. After sitting for 30 minutes after getting the vaccine patient felt more calm.
62 2021-01-19 chest pain Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling ... Read more
Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.
62 2021-01-20 heart rate increased, hypertension, chest discomfort 2 hours after receiving the COVID vaccine, I experienced the following: light headedness, dizziness... Read more
2 hours after receiving the COVID vaccine, I experienced the following: light headedness, dizziness, severe headache, rapid heart rate, high blood pressure, tightness in chest and fatigue
62 2021-01-20 chest discomfort Pressure on the chest, labored breathing, hives on neck, upper arms, back
62 2021-01-20 chest discomfort, hypertension ~ 10 minutes after vaccine, patient started c/o chest tightness and SOA. Pulse ox was 95%, BP 204/7... Read more
~ 10 minutes after vaccine, patient started c/o chest tightness and SOA. Pulse ox was 95%, BP 204/79, P-83. Patient stated that she experienced same symptoms when she went to ED for chest pain and was given Morphine. At 10:04 AM Patient was given Pepcid 20 mg, Benadryl 25 mg, and Zyrtec po. She had difficulty swallowing those pills. Lung sounds clear. Oriented X3. EKG was normal. After about one hour of observation with no relief, she was transferred to UKED. BP was 131/50, P-97 and Pulse ox 98% just prior to transfer.
62 2021-01-21 chest discomfort, heart flutter Patient was given the Pfizer vaccine at 9:27 on 01/21/21. At about 5 minutes post vaccine she was n... Read more
Patient was given the Pfizer vaccine at 9:27 on 01/21/21. At about 5 minutes post vaccine she was noted to have some throat clearing but denied any concerning symptoms. At 9:40 she began experiencing fluttering in her chest and at 9:41 she was noted to have some chest tightness and wheezing. She was given Benadryl 50 mg oral at 9:42 but then symptoms began to progress and she started to have angioedema of her upper lip and her hands/arms started itching and she was noted to have some early hives. Epipen 0.3 mg was given at 9:45. She continued to have some swelling of her upper lip and chest tightness and soulmedrol 125 mg IM was given at 9:49 and then she was placed on O2 via NC at 2 L. At 9:50 she stated that her throat swelling was starting to improve and her chest tightness and wheezing was getting better. EMS arrived at about 9:51 and report was given and care turned over to them. They left the clinic at 10:00 without further incident.
62 2021-01-23 palpitations Pt began to have tightness in throat, heart palpitations, nausea after 10 minutes past administratio... Read more
Pt began to have tightness in throat, heart palpitations, nausea after 10 minutes past administration of vaccine. Approx 5 min later noted color change in lips.
62 2021-01-24 heart rate increased, hypertension, fast heart rate Tachycardia and hypertension feels hot and heart rate was high
62 2021-01-24 chest discomfort Wheezing, chest tightness, dizziness, stomach cramps, nausea
62 2021-01-24 palpitations minutes after injection started reacting with, palpitations, shortness of air and nausea. went to Ed... Read more
minutes after injection started reacting with, palpitations, shortness of air and nausea. went to Ed and received IM epi\listed vaccine as allergy
62 2021-01-25 chest discomfort HA; Fatigue; DOE; Chest pressure; Fever 100.2; Sudden coughing spell; This is a spontaneous report f... Read more
HA; Fatigue; DOE; Chest pressure; Fever 100.2; Sudden coughing spell; This is a spontaneous report from a contactable Nurse (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EL3248) on 12Jan2021 18:00 at SINGLE DOSE on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history included essential hypertension (Essential HTN), cardiac output (PLR). Concomitant medication received within 2 weeks of vaccination included lisinopril. The patient previously received first dose of BNT162B2 (Lot number=EL1284) on 23Dec2020 07:00 PM at SINGLE DOSE on Left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Headache (HA), Fatigue, Dyspnea on effort (DOE), chest pressure, fever 100.2, sudden coughing spell that lasted hours during the night on 13Jan2021 06:30 AM. The outcome was Recovering. No treatment received for the adverse events. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
62 2021-01-26 palpitations Patient reported on 1-27-21 at 11:40am to Employee Health office that on 1-8-21 3:15pm received COVI... Read more
Patient reported on 1-27-21 at 11:40am to Employee Health office that on 1-8-21 3:15pm received COVID dose #1 at staff COVID vaccination clinic - waited 15 minute observation then returned to workstation. About 20 minutes after vaccination began experiencing light headedness, anxiousness, agitation and heart racing. Symptoms increased over next 1-2 days then diminished over the following week. Did not report symptoms. Stated "feeling like myself now"
62 2021-01-27 fast heart rate, fainting Itching at injection site Flushing Tachycardia Syncope Unable to control BUE?s. Felt very heavy
62 2021-01-27 blood pressure increased Within a minute -face,ears,neck turned bright red. Paramedics took EKG and BP was 211/110. That mor... Read more
Within a minute -face,ears,neck turned bright red. Paramedics took EKG and BP was 211/110. That morning ( I check it regularly due to salt sensitivity) it was 123/69 (Normally 120-140/ 60-76.
62 2021-01-27 palpitations approximately 10 minutes after receiving vaccine patient complained of fullness in throat and diffic... Read more
approximately 10 minutes after receiving vaccine patient complained of fullness in throat and difficulty swallowing, also felt tremulous and like heart was racing, some visible swelling of lower lip, initial vitals revealed pulse ox of 99, bp 151/70 and hr of 107, lungs clear without wheezing, no urticaria, given 25mg po Benadryl with gradual resolution of symptoms and normalization of vital signs
62 2021-01-28 hypertension Headache, HYPERtension, FATIGUE Narrative: PATIENT HOSPITALIZED OVERNOC w/HTN urgency. patient late... Read more
Headache, HYPERtension, FATIGUE Narrative: PATIENT HOSPITALIZED OVERNOC w/HTN urgency. patient later seen by PCP endorsing improvement of symptoms. pt further endorsed feeling lightheaded with vaccination # 1. pt also with c/o increased burping.
62 2021-01-31 blood pressure increased I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy his... Read more
I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy history. I was advised by the allergist to take Allegra an hour before receiving the vaccine. About 10 minutes after receiving the vaccine, I started to throat my started to feel dry and tickling, it felt like it swelling starting from the left side to the center, I started having difficulties swallowing my salvia and any fluid. My blood pressure was checked and it was elevated. I started to have difficulty breathing. They transferred me over to the ER. They gave me IV medicines Benadryl, Prednisone, Pepcid (I think). After 6 hours I was able to go home. Everything went back to normal besides the pain in the left arm at injection site. I had a telemedicine visit today with my primary care physician to follow up.
62 2021-01-31 cardiac arrest she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transpor... Read more
she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transported to the hospital. i was told she had tested positive for COVID 2 times once at the home and once at the hospital. with in 2 DAYS at the hospital she wa on a ventilator 2 days later she died. i talked with the rehab center and confirmed she tested negative for COVID on Dec 27th 2020 and was given the Vaccine on the 29th Dec 202 was in the hospital 4 day later, was on a ventilator 4 days after that then died a few day later as her heart stopped beating. all the while i had POA and was not contacted by Hospital staff until after they had made the next step.
62 2021-02-01 blood pressure increased, fainting Dizziness, Increase Blood Pressure, Fainting, Fatigue,
62 2021-02-01 chest discomfort pressure across chest; eyes were very swollen; flu symptoms; severe aches/ Pain radiated bilaterall... Read more
pressure across chest; eyes were very swollen; flu symptoms; severe aches/ Pain radiated bilaterally up neck, mandibular area, trigeminal and into head; abdominal pain; nausea; Injection site very painful, could not touch; This is a spontaneous report from a contactable nurse reported for herself. This 62 Years old patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 12Jan2021 13:15 on Arm left at single dose (Lot # EL0142) for covid-19 immunisation. Medical history included hashimoto disease, allergies to maxide. Prior to vaccination, was the patient did not diagnose with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), valsartan, Pravastatin, docusate sodium (COLACE), wool fat (EUCERIN) and Vitamin D Nos. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 22Dec2020 13:15 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. The patient woke up 13Jan2021 at 2:00 AM with flu symptoms - severe aches, abdominal pain and nausea. By 13Jan2021 4:30 eyes were very swollen. Slept 14 hours. Next night 14Jan2021 at 1AM, severe arm pain radiating across chest to other armpit - pressure across chest. Pain radiated bilaterally up neck, mandibular area, trigeminal and into head. Injection site very painful - could not touch in Jan2021. As the pain at injection site subsided - so did the symptoms. Events were non serious. No treatments were received. On 15Jan2021, laboratory details included nasal swab which showed negative. Outcome of the events was recovered.
62 2021-02-01 palpitations, heart rate increased racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60)... Read more
racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60); Very weak; chills; whole body achiness; This is a spontaneous report from a non-contactable nurse (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176) via an unspecified route of administration on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included coronavirus and allergies: sensitive to milk protein and gluten sensitivity. Concomitant medication included St John's Wort, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium carbonate (TUMS [CALCIUM CARBONATE]) and multivitamin. The patient previously took casein and experienced allergies. On 19Jan2021 05:00 AM, the patient experienced racing pounding heart rate 110-126 (normal is 60), very weak, chills, whole body achiness. Work the night shift, 11p-7a and symptoms started around 5am. No treatment was received for the events. Patient was not pregnant. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
62 2021-02-02 blood pressure increased, fainting Systemic: Fainting-Medium, Systemic: Other- Increase Blood Presure
62 2021-02-03 chest discomfort Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye a... Read more
Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye and nose; burning eye and nose; weakness; tiredness; sore lips and throat; sore lips and throat; sore on tongue; chest tightness; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, high cholesterol, diabetes mellitus, allergies penicillin. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included atenolol (manufacturer unknown), losartan (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazid (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 07:00 the patient experienced dizziness, nausea, headache, constant eye and nose drain, burning eye and nose, weakness, tiredness, sore lips and throat, sore on tongue, chest tightness. The patient underwent lab tests and procedures which included Sars-cov-2 nasal swab test: negative on 19Jan2021. The outcome of all events was not recovered as all ongoing now for 1 week. The events were considered non serious. Information on the lot/batch number has been requested.
62 2021-02-03 fast heart rate PER MD: HIGH FEVER, TACHYCARDIA, HALUCINATIONS, CHANGE IN MENTAL STATUS
62 2021-02-03 chest pain, palpitations Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexert... Read more
Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexertional chest ache for several hours resolved with fluids and Tylenol/motrin.
62 2021-02-04 hypertension My blood pressure shoots up really high; My upper body got red like tomato; I was really like confus... Read more
My blood pressure shoots up really high; My upper body got red like tomato; I was really like confused for several hours; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at left shoulder on an unspecified date at single dose for COVID-19 immunization. The patient medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient reported that: "my reaction was my blood pressure shoots up really high and my upper body got red like tomato and I was really like confused and 'spacing' for several hours". The patient did not receive any treatment. The patient outcome of the events was unknown.
62 2021-02-08 transient ischaemic attack Pfizer-BioNTech COVID-19 vaccine EUA---- 2/4/21 0430am woke up with numbness in left leg which progr... Read more
Pfizer-BioNTech COVID-19 vaccine EUA---- 2/4/21 0430am woke up with numbness in left leg which progressed to entire left side of body. 02/05/21 03:30 PM presented to ER for evaluation of left side body numbness. Numerous test & blood work performed. D/C home with diagnosis of transient cerebral ischemia & instructed to follow up with neurologist.
62 2021-02-08 heart rate increased heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This i... Read more
heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 62 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) administered on 30Dec2020 at 01:00PM and the patient said she did not have a reaction after the first vaccine. The patient received no concomitant medications. She stated that she had no other recent vaccinations or new medications. One thing that may be important is that she did do a 7 day detox that ended the Sunday before her second vaccine dose, so her body was pretty much having no impurities in it, and she has been eating clean since then, maybe having something foreign put into her body set it off after detox. The patient experienced arm soreness and general fatigue on 21Jan2021, and on 22Jan2021 at 01:00 she experienced severe nausea and heart rate of 160 (which was reported serious as medically significant). Patient reported that after her second dose of the COVID-19 vaccine she had a significant side effect that didn't happen until 10-12 hours after getting the vaccine. She did not have a reaction after the first vaccine. After the second injection her arm was sore, and she had general fatigue. She had the second dose injected Thursday at around 01:00PM, then at one in the morning her heart rate was 160, and she had severe nausea. She was that way until 08:00AM. Her heart rate was 120 probably by 09:00AM, then came down to 100, she has never had anything like that before. Her arm soreness was a deep muscle soreness to her left arm. The fatigue was a couple hours later after she got the second dose of the vaccine. The nausea started at 01:00AM, and lasted until six to eight, she did no treatment, and it improved and is still gone now. For her heart rate of 160, she had no treatment, though she probably should have gone to the hospital, but it came down. She usually runs a heart rate of 60-70, it went back to normal Friday, probably in the afternoon on the 22nd, about 12 hours after that started. The patient stated that she feels this is medically significant for her heart rate to be that high. She had contacted her primary care physician (PCP), but they didn't call her back for 4-5 hours, by then she was fine. She doesn't think that this was treated well by her PCP, and that they should have done an electrocardiogram (EKG) and follow up labs, she is changing her PCP as a result of this. She is concerned about the people who will be getting their second dose, she has been helping with these, they have patients that are over 100, they wouldn't survive that rapid heartbeat. The outcome of arm soreness/muscle soreness and fatigue was unknown.; Sender's Comments: The reported event of heart rate increased was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
62 2021-02-10 blood pressure increased, palpitations 1st shot 1/13/21, 2nd shot 2/3/21 0830 am 1st dose pfizer # EK 9231, 2nd dose pfizer# EL8982 shiver... Read more
1st shot 1/13/21, 2nd shot 2/3/21 0830 am 1st dose pfizer # EK 9231, 2nd dose pfizer# EL8982 shivers, heart pounding, bp 153/86 elevated for her, congestion
62 2021-02-10 hypertension, fast heart rate, heart rate increased Hypertension; tachycardia; Feels hot; heart rate is high; This is a spontaneous report from a contac... Read more
Hypertension; tachycardia; Feels hot; heart rate is high; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies. Concomitant medication included simvastatin and acetylsalicylic acid (ASPIRIN (E.C.). The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hypertension, tachycardia, feels hot and heart rate is high on 13Jan2021. The outcome of the events was recovering. The patient received treatment such as Amlodipine and lisinopril oral for the events.
62 2021-02-10 fainting, loss of consciousness, pallor collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and s... Read more
collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats. After coming too, drank electrolytes and water. The patient got the chills after sweating. It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.
62 2021-02-11 chest discomfort Prior hx. of anapylaxis from ferrlicit, hives from gallalinium, sulfa drugs and clindamycin. Receive... Read more
Prior hx. of anapylaxis from ferrlicit, hives from gallalinium, sulfa drugs and clindamycin. Received Trastuzubam yesterday. Individual from pharmacy called and approved vaccine administration. At 11:37 am patient noted tingling in both arms and legs and slight light-headedness. Denied any trouble swallowing, facial or tongue swelling. states a little chest tightness but not enough to take her inhaler. Vital signs at 12:09pm BP 149/75, pulse 90, Pulse ox. 100%.At 12:20pm patient still admits to bilateral leg and arm tingling, no facial/tongue swelling or difficulty swallowing. No change in chest tightness.
62 2021-02-15 chest discomfort Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertig... Read more
Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertigo. Felt feverish but no temp. Severity so bad almost went to ER. Took Imitrex x2 with chest tightness occurring after 2nd dose. Lasted x3 days then pressure on right side of head eye for a month. Elected not to do 2nd shot due to above s/s.
62 2021-02-15 palpitations Pt reports heart racing, anxiety, and a flushed feeling with onset at 1800
62 2021-02-15 palpitations, heart rate increased, blood pressure increased Pt. received vaccine at 1805 and Pt. came to RN stating she felt heart racing at 1828. RN took patie... Read more
Pt. received vaccine at 1805 and Pt. came to RN stating she felt heart racing at 1828. RN took patient to sit in observation area. Asked if any trouble breathing, stated no. RN noted patient with flushed face and red sclera. Patient placed on monitor with HR in 113, oxygen saturation 97% and blood pressure 186/108. Oral benadryl given at 1832 with water. Patient continue on monitor with HR in 107, at saturation 97% and blood pressure 186/103. 911 called at 1835 due to blood pressure issue and cont. flushed. EMT arrived 1842 and took over care. Pt. EKG done by them and then taken to ER at 1900.
62 2021-02-18 heart rate increased Patient received second dose of Pfizer vaccine and after about 20 minutes of receiving dose began to... Read more
Patient received second dose of Pfizer vaccine and after about 20 minutes of receiving dose began to feel dizzy and vomit. Heart rate slightly elevated. Patient was taken to emergency room for further evaluation.
62 2021-02-21 chest pain 01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Calle... Read more
01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.
62 2021-02-21 fast heart rate, palpitations Tachycardia: Palpitations started at 0900 Dr at bedside immediately. Reports hx of SVT. VS @ 09... Read more
Tachycardia: Palpitations started at 0900 Dr at bedside immediately. Reports hx of SVT. VS @ 0904 BP 142/85 HR 146-169 pulse ox on RA PT husband called at 0908 came inside with wife at 09:11 with service dog. Service dog presence made pt calm immediately Palpiatations resolved at 0912 no complaints VS @ 0913 130/85 HR 120 100@ Pt insisted she feels 100% better at 0930 on decided to leave facility with husband and service dog at this time
62 2021-02-22 hypotension Body aches, low blood pressure, tingling sensation in hands, symptoms lasted for a week.
62 2021-02-23 arrhythmia PVC's for 27 hours (Arrhythmia)
62 2021-02-24 chest pain Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also report... Read more
Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also reports itching and burning sensations in affected area. Patient went to urgent care (2/25/21) and was diagnosed with shingles. Patient was prescribed valtrex.
62 2021-02-25 blood pressure increased Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and ... Read more
Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and cheeks, elevated blood pressure 138/115 to 140/73
62 2021-02-25 blood pressure increased Patient reports feeling lightheaded after receiving her first dose of pfizer vaccine. Vital signs ta... Read more
Patient reports feeling lightheaded after receiving her first dose of pfizer vaccine. Vital signs taken, BP 162/78, slightly elevated, no other concerns. Patient refused second set of vitals or any other care, refused any transport. Patient left by self.
62 2021-02-26 body temperature decreased For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my ... Read more
For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my temperature dropped to 93 degrees. When I finished with these symptoms my temperature climbed back up to 97.7. I have been having intermittent belly pains since then but they are nothing like they were last night and they are getting more mild and far between as I write this.
62 2021-02-26 heart rate increased, pallor high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas. My arm flet ... Read more
high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas. My arm flet like it had a fever at injection sight. I was pale in face.
62 2021-02-28 palpitations Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoar... Read more
Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.
62 2021-03-01 blood pressure increased Double vision Dizzy Elevated Blood Pressure Light sensitivity Fatigue Symptoms lasted for 10 hours,... Read more
Double vision Dizzy Elevated Blood Pressure Light sensitivity Fatigue Symptoms lasted for 10 hours, monitored BP, monitored other symptoms (short naps, kept eyes closed as much as possible, minimal light
62 2021-03-02 blood glucose increased Partial CN 3 Palsy, right side Symptoms: Diplopia, Ptosis
62 2021-03-03 heart rate increased Patient was complaining of increased heart rate and nausea about 20 minutes following the vaccine.... Read more
Patient was complaining of increased heart rate and nausea about 20 minutes following the vaccine. Patient also mentioned she had just had blood work done that morning before coming to get her vaccine so the pharmacy staff gave her some bottled water. Patient requested an ambulance and wanted to be transported.
62 2021-03-03 blood pressure increased Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm coul... Read more
Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm. Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
62 2021-03-03 chest discomfort WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, IT... Read more
WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES. ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS. THE NEXT DAY HAD A VERY BAD HEADACHE. ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS. HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION. ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.
62 2021-03-04 blood glucose increased Blood sugar rose to 501one hour after vaccine. It was 166 in the am Never has been that high Left a... Read more
Blood sugar rose to 501one hour after vaccine. It was 166 in the am Never has been that high Left arm vaccine rm tingled and numb all the way to finger tips
62 2021-03-04 chest discomfort I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day... Read more
I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.
62 2021-03-05 pallor 15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card,... Read more
15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card, my pocketbook, felt pretty disoriented. I remember someone telling me to sit down and eat something. (I had already had lunch and a snack). That evening I started to have a bad headache. Thursday morning I had a very difficult time getting up and was extremely fatigued; felt hot. I felt exhausted all day and looked pretty tired and pale. Friday morning still tired, had some bouts of energy, but they didn't last long. Body aches were worse and I also had some stomach discomfort Saturday felt like I had a sore throat, felt weak, and still pretty tired. I had some problems catching my breath when climbing stair and and at one point felt hot and clammy. Headache was better.
62 2021-03-05 blood pressure increased Pt felt light headed, had Elevated BP 177/1106, HR 86, Pulse Ox 98% on room air, very anxious, place... Read more
Pt felt light headed, had Elevated BP 177/1106, HR 86, Pulse Ox 98% on room air, very anxious, placed on cot, feet up, with OS symptoms improved as did blood pressure
62 2021-03-05 heart rate increased Within about 5 minutes after the injection, I experienced the following symptoms, in this order: 1) ... Read more
Within about 5 minutes after the injection, I experienced the following symptoms, in this order: 1) Light headedness 2) Increase heart rate 3) Hands tingling 4) Upper Lip numbness
62 2021-03-07 heart rate increased Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable he... Read more
Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6201), via an unspecified route of administration on 05Feb2021 at 08:15 on the left arm at a single dose for COVID-19 immunization. Medical history included sleep apnea from an unknown date and unknown if ongoing and meningioma removal on an unspecified date, 3 years ago. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rapid heart beat, jitteriness, fatigue and sore arm on 05Feb2021 at 10:00. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
62 2021-03-08 hypertension C/O feeling like her BP was high, had patient first drink water and lay down, then sent her to ED, t... Read more
C/O feeling like her BP was high, had patient first drink water and lay down, then sent her to ED, they transferred her to hospital for admission.
62 2021-03-08 blood pressure increased Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my ... Read more
Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.
62 2021-03-08 heart rate increased Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of... Read more
Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of being high lasting 10 minutes, elevated heart rate, dizziness and weakness for 1-2 minutes length, blurred vision and "brain fog" lasting for about 24 hours
62 2021-03-08 fainting Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT... Read more
Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT came to my aid and took vitals all looked OK. I stayed in place until I felt better about 30 minutes. For the rest of that day and the next day I was extremely tired, a little nauseous, and kind of out of it. The third day I had very sore left arm at site and very sore and tender lymph notes on left side of Arm and trunk. Six days after the shot I came suddenly down with a massive headache and diarrhea. Al has since resolved and I am on day eight.
62 2021-03-09 blood pressure increased Patient received vaccination at pharmacy and then went to office in back of store to work. received ... Read more
Patient received vaccination at pharmacy and then went to office in back of store to work. received call from back about 1 hour later stated patient was feeling unusual. Went to back of store and checked patient. Patients blood pressure was elevated at 180/100. Patient temperature was normal. Discussed with patient and she decided that she would like to go to clinic to be checked
62 2021-03-10 palpitations Inside of body felt like it was on FIRE!! Mouth burning! Heart racing with minimal movement, shortne... Read more
Inside of body felt like it was on FIRE!! Mouth burning! Heart racing with minimal movement, shortness of breath,
62 2021-03-13 palpitations, heart rate increased Day1 & 2 sore arm fatigue Day 3 swollen lymph nodes, Day 18 palpitations
62 2021-03-13 heart rate increased dizziness, elevated HR. Evaluated by EMS-Cleared
62 2021-03-14 chest pain A couple of days after at 10:30 PM I had a fever of 101.5 with a headache in the front on top of my ... Read more
A couple of days after at 10:30 PM I had a fever of 101.5 with a headache in the front on top of my forehead. I stayed home from work the next day and my fever was 100.0. Tylenol helped. I felt tired but better. It became difficult to breath. It felt like I had chest pains especially on exertion. It improved if I sat down. It lasted aa week. My doctor sent me for a chest x-ray and blood tests. I had contracted Covid-19 on the third week after my first dose of the vaccine. Positive test results on 01/11/2021.
62 2021-03-14 chest discomfort Approximately 15 minutes after vaccination, patient began feeling bumps on lip and swelling under ja... Read more
Approximately 15 minutes after vaccination, patient began feeling bumps on lip and swelling under jaw. Soon after, she felt flushed with itching in feet and swelling of feet. I observed a mild redness to face and upper chest. I saw no swelling of neck, lips or oral cavity. I ordered 25 mg. benedryl po be administered at 3:10 PM. A few minutes later, she felt tightness in chest. At that point (3:15 PM) an EMT tried to inject an Epipen but only left the pen in for less than 1/4 second before she withdrew the pen. I then administered another Epipen directly after and the pen was in her thigh for over 3 seconds. The patient was transferred light and sirens to ER. She received no further Epi in the ER and received steroids, benedryl, and famotidine according to the ER Resident. She was doing well 90 minutes after vaccination per Dr.
62 2021-03-14 palpitations On day 3 after the injection, I started experiencing heart palpitations. That lasted for about an ho... Read more
On day 3 after the injection, I started experiencing heart palpitations. That lasted for about an hour and didn't happen again until the next evening, around 5pm. That episode lasted for hours, and I finally went to bed at 9pm due to being so tired. The palpitations stopped sometime in the night. The next afternoon, I decided to lay down for a bit as I was still feeling quite a lot of fatigue and SOME body aches since the day after the injection. When I laid down, palpitations started again within just a few minutes. I got up, and they stopped in a few minutes. Since that last episode, I have only had the occasional "flip-flop" in my heart. I've never had palpitations prior to this, (beta blocker is for a too fast heart rate with no palpitations)so thought it might be a reaction. I'm scheduled for the 2nd dose on 3/27 and want to make sure it is safe for me to get that. Contacted my Doctor's office this morning, but haven't heard back as yet.
62 2021-03-14 excessive bleeding she felt something in her foot (right foot) under the toes like she had sept on something like the l... Read more
she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown. Information on lot/batch has been requested.
62 2021-03-15 chest discomfort Allergic-Anaphylaxis Itching 17 min after administration, redness, rash, chest pressure under heart.... Read more
Allergic-Anaphylaxis Itching 17 min after administration, redness, rash, chest pressure under heart. Facility called 911 administered Benadryl via IV transported to ER Once in ED given Epipen at 2:21 and Decadron @ 6:05, discharged at 6:60 pm
62 2021-03-15 chest discomfort, heart rate increased Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting... Read more
Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting within 1/2 hour. I am four days into symptoms. I still have some chest heaviness and still having asthma issues which includes coughing. I also had side effects of sore arm, chills, fatigue. Did not seek treatment. I had no idea how long this would last. I wish I would have read the paperwork for severe allergic reaction, but I didn't. I would have gone to the ER. I have suffered with this since Saturday.
62 2021-03-15 blood clot Pfizer-BioNTech Covid vaccine, first shot developed a blood clot in a superficial vein the day after... Read more
Pfizer-BioNTech Covid vaccine, first shot developed a blood clot in a superficial vein the day after the vaccine, was diagnosed by a doctor as "superficial thrombophlebitis, pain swelling in leg. Treatment of ibuprofren started. Wondering if I should take my second shot which is scheduled for MArch 26
62 2021-03-15 chest pain Reported chest pain, shortness and of breath, and headache. Transferred to the ED. Symptoms resolved... Read more
Reported chest pain, shortness and of breath, and headache. Transferred to the ED. Symptoms resolved. Followed up with PCP.
62 2021-03-17 chest discomfort, chest pain, blood pressure increased I had chest pressure and chest pain. 160/100 - blood pressure when I checked it. I just didn't feel ... Read more
I had chest pressure and chest pain. 160/100 - blood pressure when I checked it. I just didn't feel good. I went to my doctor - they increased my blood pressure med dosage. Next day, I saw a cardiologist (16th) and he had another medication: Hydroclorothyrozide - HCTZ - 12.5 mg daily. Eventually they had to increase the HCTZ about two weeks ago and now my blood pressure is normal.
62 2021-03-18 chest discomfort About 30 minutes after vaccine, started to have a hard time breathing, short of breath & "chest fe... Read more
About 30 minutes after vaccine, started to have a hard time breathing, short of breath & "chest felt heavy" while at work at desk. Called an ED response- taken to ED was monitored for 4 hours, then released to home. That evening experienced fatigue, headache, muscle/body aches, feverish, which continued on 1/19 ,1/20, 1/ 21. felt better on 1/22/21 afternoon.
62 2021-03-18 low platelet count, platelet count decreased Patient was found in house by EMS with agonal respirations. Patient was intubated on scene and broug... Read more
Patient was found in house by EMS with agonal respirations. Patient was intubated on scene and brought to ER. At ER, patient presented with a HR of 55, BP of 80/43, O2 of 99%, and a rectal temperature of 107.3F. Further work-up revealed thrombocytopenia with a platelet count of 63, WBC of 13.7, and an elevated lactate of 2.2. Imaging shows a kidney stone obstruction of the right ureter. Diagnosis of sepsis was made with patient admitted to the hospital. Repeat rectal temp after acetaminophen suppository and external cooling continues to be 107. Care is ongoing at time of this report.
62 2021-03-18 hypotension, very slow heart rate Sudden onset one hour after vaccine of severe irritable bowel. Became diaphoretic, bradycardic and ... Read more
Sudden onset one hour after vaccine of severe irritable bowel. Became diaphoretic, bradycardic and hypotensive and extreme abd pain. Was taken to the Emergency Room by coworker (I work in the hospital)
62 2021-03-19 chest discomfort tingling in legs, nausea, headache, pressure in chest, back pain
62 2021-03-20 blood pressure increased, fainting No symptoms after the vaccination on the day of or the day after getting the vaccine. Two days afte... Read more
No symptoms after the vaccination on the day of or the day after getting the vaccine. Two days after the vaccine, while at orthopedist (for a Rotator Cuff Surgery), I began to feel dizzy. I sat down for a few minutes, drank some water, and then resumed my therapy. After the first set of my 4th exercises I began to get dizzy, I sat down on the PT table, then laid down and fainted for about 1-2 seconds. My blood pressure plummeted to 60/?. EMT?s and an ambulance were called. I was given an IV and taken to hospital. In the ER, my blood pressure elevated to 205/121. (I think that was it.) I was given a cat scan, ekg, chest X-ray, blood tests, etc. All tests were normal except a very slight (by one number) magnesium level. I was admitted for observation and more tests where performed. My blood pressure remained high, but I had no more dizziness or syncope. I was given many more blood tests, imagining, ultrasound of heart, ultrasound of carotid arteries, ultrasound ?bubble test,? nuclear heart treadmill stress test. All tests were normal. The only change in my health that can be attributed to this episode is the Covid vaccine.
62 2021-03-21 heart rate increased 3/22/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screeni... Read more
3/22/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: rapid heart rate. And clammy Assessment : Time of assessment 1613 Alert and oriented. Actions taken: Vs taken at 1613 BP- 121/69 P- 72, water offered Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/22/2021 3:36 PM 0.3 mL 12/11/2020 Intramuscular
62 2021-03-21 chest pain AFTER VACCINE, WHILE IN OBSERVATION AREA PATIENT HAD SUBSTERNAL CHEST PAIN FOR AT LEAST 5 MIN. REFUS... Read more
AFTER VACCINE, WHILE IN OBSERVATION AREA PATIENT HAD SUBSTERNAL CHEST PAIN FOR AT LEAST 5 MIN. REFUSED TRANSPORT TO HOSPITAL VIA EMS
62 2021-03-21 chest discomfort Developed chest tightness shortly after vaccine. Denies shortness of breath. Patient was taken to ... Read more
Developed chest tightness shortly after vaccine. Denies shortness of breath. Patient was taken to urgent care for evaluation, but ultimately did not need any further work-up. Questionable if patient even needed to be taken to urgent care based on our adverse reaction algorithm for COVID vaccination, but since she was transferred there, do feel obligated to submit report. Patient has had a history of reactions to other medications (primarily chemotherapeutic agents) that have manifested similarly to this. Discharged in stable condition.
62 2021-03-21 blood clot blood clot formed in left arm; This is a spontaneous report from a contactable consumer (patient). A... Read more
blood clot formed in left arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient, not pregnant at time of vaccination, received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198), via an unspecified route of administration, on right Arm on 27Feb2021 0100, SINGLE DOSE for covid-19 immunisation. Medical history included Diabetic, High blood pressure, both from an unknown date. Concomitant medications included glipizide, metformin, fenofibrate. The patient previously took sumatriptan succinate (IMITREX) and experienced drug allergy. After vaccination 6 days later (05Mar2021) a blood clot formed in left arm. Shot was given in right arm. Hospitalization followed and now on blood thinners. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 2 days. The outcome of the event was not recovered. Eliquis was given as treatment for the event. No covid prior vaccination. Not covid tested post vaccination.
62 2021-03-21 fainting syncopal episode shortly after receiving vaccine.
62 2021-03-22 heart flutter About 7 hours after injection, I had a large flutter feeling in my chest that lasted about 3-5 secon... Read more
About 7 hours after injection, I had a large flutter feeling in my chest that lasted about 3-5 seconds. It happened again about 10 minutes later, nothing after that.
62 2021-03-22 hypertension Headache at 5 pm, then severe difficulty swallowing and breathing and HBP started at 7:00 pm, went t... Read more
Headache at 5 pm, then severe difficulty swallowing and breathing and HBP started at 7:00 pm, went to ER, release at 2 am still having symptoms, not as severe. After 48 hours all symptoms gone.
62 2021-03-22 chest pain Intense enough Chest pain; jaw pain; back pain; nausea; This is a spontaneous report from a contacta... Read more
Intense enough Chest pain; jaw pain; back pain; nausea; This is a spontaneous report from a contactable consumer. A 62-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm, on 18Feb2021 at 14:00 (Batch/Lot Number: EL9267) as SINGLE DOSE for covid-19 immunisation Medical history included hypertension and allergy to penicillin. Concomitant medication and pravastatin (PRAVASTATIN. On 19Feb2021 at 100am, the patient experienced chest pain and jaw pain where she seriously considered going to the ER. Also, the other common side effects of back pain and nausea. The outcome of the events was recovering. The patient was not hospitalized nor was treatment received.
62 2021-03-22 heart rate increased Patient had a seizure blood pressure and pulse elevated. Known history of seizures. Went to ER
62 2021-03-22 chest discomfort Waited 30 minutes. A little dizzy. Son drove me home. Arrived home 450. 5 pm eyes and cheeks swellin... Read more
Waited 30 minutes. A little dizzy. Son drove me home. Arrived home 450. 5 pm eyes and cheeks swelling throat felt like olive stuck in it I called Kaiser. Talking to them chest began stinging hurting pressure. Told to call 911. I hung up walked two blocks to urgent care. Chest really hurting feeling dizzy face eyes swelling throat lump getting larger. My breathing rate normal , blood pressure normal , oxygen normal. They took me back gave me epinephrine and depo modral shot in right buttock cheek. After few minutes felt better chest stopped increasing in pain throat started feeling better, face still swollen. Told me good thing I walked instead of waiting for 911. Very scarey. Told to remain up for 24-48 hours give epi if needed again. Taking 180-360 mg 24 hr Allegra daily. I stayed up 36 hours drank water . Told can not take second shot. No vaccines until I get tested for what caused allergic reaction. Today March 23 face still off and on swelling and eyes. Seems when I begin to move around swelling starts again.
62 2021-03-23 loss of consciousness Chills, nausea, passed out, muscle aches
62 2021-03-23 fast heart rate, chest discomfort, heart rate increased I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer ... Read more
I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer vaccine #1--flushed/hot, strong metallic taste, chemical smell, tachycardia (156-158), nausea, some chest discomfort and dizziness. BP 158/85 (my normal is 100/60). O2 sats 98%. I did not feel anxious until heart rate would not come down to baseline. Clinic staff monitored me and did not treat. Allowed heart rate to decrease over time. Took over 20 minutes to get below 120. At 35 minutes, it was below 100. Stayed at clinic for one hour and released. Still had metallic taste (over 3 days now), loss taste, loss of appetite, headache, and fatigue.
62 2021-03-23 chest pain, heart attack Patient received first COVID-19 dose on Jan 14th, 2021 and then developed chest pain and diarrhea 1 ... Read more
Patient received first COVID-19 dose on Jan 14th, 2021 and then developed chest pain and diarrhea 1 day later. On Jan 17th, she presented to hospital and was found to have an non-ST elevated MI and apical ballooning syndrome.
62 2021-03-23 pallor Pt received 2nd dose pfizer @ 0800 Pt found by observer @ 0802 with increased WOB, pale skin, pt una... Read more
Pt received 2nd dose pfizer @ 0800 Pt found by observer @ 0802 with increased WOB, pale skin, pt unable to speak in full sentences due to SOB. Lungs sounds assessed and noted to be wheezy, x1 does Epi administered, 911 called. 0803- BP 100/60, HR-100, RR 32, SPO2- 92, Pt breathing improved after 2 mins, pt verbalizes decreased WOB. Second set of vitals- BP 110/70, HR 106, RRR- 20, SpO2, 96%. 0809- AMR arrives and assumes care of pt
62 2021-03-23 chest pain, troponin increased, heart rate increased Within 30 min of shot, starting feeling itchy tongue and throat. Drank water and within a few minut... Read more
Within 30 min of shot, starting feeling itchy tongue and throat. Drank water and within a few minutes got a full body heat flush and starting shaking all over. Heart beating fast and having some pain in chest. Drove to her work place and was assessed by MD and RN on staff. BP was 220/120, pulse over 100. She took a Claritin and was monitored in the work place. She became lethargic and chest pain continued so she went to the closest Emergency Room.
62 2021-03-24 loss of consciousness Felt the vaccine immediately in arm, Got a funny taste in my mouth, Started feeling dizzy before I s... Read more
Felt the vaccine immediately in arm, Got a funny taste in my mouth, Started feeling dizzy before I stood up, Moved to a different chair from injection chair location. Passed out. Never vomited but become very nauseated. These symptoms all occurred within five minutes of the injection. Ran low grade fever all day on March 24 (day after).
62 2021-03-24 chest pain ON 3/12/2021 I received vaccine at 12:15 pm. After it was administered I waited 15 minutes to see i... Read more
ON 3/12/2021 I received vaccine at 12:15 pm. After it was administered I waited 15 minutes to see if I got an reaction to it. I was fine until about 3:00pm in the afternoon that I started to feel fatigue, body aches, also had chest pains on left side and in shoulder. pain stayed rest of the night. subsided on Saturday and returned on Sunday. Went to Hospital Sunday Night qround 7:00pm to get heart check out.
62 2021-03-24 loss of consciousness Severe nausea for 5 days. Dizzy. Headaches. Severe pain all the way down my right arm to my finger t... Read more
Severe nausea for 5 days. Dizzy. Headaches. Severe pain all the way down my right arm to my finger tips, hand cramping off and on for 2 days. Not able to eat. Had to start taking Zofran on 4th day to be able to start slowly getting soft food in system.
62 2021-03-24 lightheadedness, hypertension Within 15-minutes of vaccination, the patient reported dizziness. EMS evaluated the patient on-site.... Read more
Within 15-minutes of vaccination, the patient reported dizziness. EMS evaluated the patient on-site. The patient was hypertensive (175/97) with a FSBG of 152 mg/dl. EKG demonstrated NSR, rate 86bpm, no ST elevation. EMS transported the patient toEmergency Department for further evaluation. In the ED, the patient reported dizziness, lightheadedness, near-syncope, aching headache, generalized fatigue, and weakness. Physician administered 25mg PO Meclizine. Upon reevaluation, the patient reported improvement and was discharged with diagnoses of Vaccine reaction and Dizziness.
62 2021-03-25 heart rate increased, palpitations, blood pressure increased Three hours after the injection I felt my throat getting sticky / constricting and my heart started ... Read more
Three hours after the injection I felt my throat getting sticky / constricting and my heart started pounding. Resting pulse got up to 112 bpm, and when I arrived at the ER, my blood pressure was 202/85.
62 2021-03-25 blood pressure increased c/o severe itching at injection site that then extended to legs and both arms. Vitals: at 1040 BP 1... Read more
c/o severe itching at injection site that then extended to legs and both arms. Vitals: at 1040 BP 199/110, HR 68, RR 14, O2 SAT 100%, Alert/oriented. Pt given Benadryl 25mg@1042a, pt initially declined Benadryl 50mg po as recommended; A 2nd dose of Benadryl 25mg po was given at 1054a for worsening itching. Care transfered to on-site EMS, remaining Vitals per EMS. At 1100a INT placed to Lt AC area. At 1108a Solumedrol 125mg IV given per EMS for worsening itching. Paramedics arrived @ 1128 to transport patient; they departed to the hospital at 1129a in route to NSH Duluth.
62 2021-03-26 hypertension Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pr... Read more
Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pressure
62 2021-03-26 palpitations Heart palpitations for 3 hours (11:30-2:30), dizziness, slight headache that morning, soreness at in... Read more
Heart palpitations for 3 hours (11:30-2:30), dizziness, slight headache that morning, soreness at injection site. I left work early and went home to lay down. I took 2 aspirin. I slept for 20 minutes and woke up feeling better. My doctors office was closed since this happened on a Friday. I consulted with a friend that is a RN and she advised going to emergency room. I have horrible health insurance so I didn?t want to pay 650.00 to go to emergency room. I?m not sure I want to get the second shot since I have heard that adverse reactions increase with the second shot.
62 2021-03-26 chest discomfort Pain in neck, especially, has increased over the past couple of days. Very tired, aching, lethargic,... Read more
Pain in neck, especially, has increased over the past couple of days. Very tired, aching, lethargic, don't want to be bothered. Loss of appetite started today. Feel pressure in chest, but no cough to speak of.
62 2021-03-26 blood pressure increased, palpitations Patient returned to the pod at 1219 after receiving her vaccine at 1201. pt states when she got to ... Read more
Patient returned to the pod at 1219 after receiving her vaccine at 1201. pt states when she got to her car she began to feel dizzy and lightheaded. pt is also now having heart palpitations. no shortness of breath. no other symptoms. pt was assessed and vitals taken. bp is elevated at 189/120. all other vitals normal. additional rig was called for transport at 1243 due to rig on scene being dedicated to the standby. pt was further treated with an iv 20 gauge saline lock left forearm, and a 4 and 12 lead on the cardiac monitor. pts 12 lead showed a sinus rhythm with right bundle branch block. pt states she has no cardiac hx. kunkel medic 6 arrived at apprx 1255 and transported her to at 1300.
62 2021-03-27 chest pain, increased heart rate Pt was admitted on 3/27/2021 with c/o chest pain and new sob and new sinus tachycardia x 3 days. saw... Read more
Pt was admitted on 3/27/2021 with c/o chest pain and new sob and new sinus tachycardia x 3 days. saw pcp who felt she had an abnl ekg and sent her to ER. troponin was neg. She was found to have new sinus tachycardia with out cause associated with chest pain. she will be following up with cardiology for echo and stress test.
62 2021-03-28 deep vein blood clot, pulmonary embolism 1 week later, left calf pain, SOB
62 2021-03-28 chest discomfort, chest pain Second day tired and head ache 3rd and 4th day i felt good Friday tired and tight chest, continued... Read more
Second day tired and head ache 3rd and 4th day i felt good Friday tired and tight chest, continued on Saturday Woke up sunday after sleeping 14 hours straight tight chest and head ache continues Monday headache and tight chest and pain onleft side of upper chest.
62 2021-03-30 chest pain I had the normal flu like symptoms for 2-3 days; whole upper left quadrant of my body. This includes... Read more
I had the normal flu like symptoms for 2-3 days; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; my neck arm and shoulder were killing me; my neck arm and shoulder were killing me; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; This is a spontaneous report from a contactable consumer. A 62-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 18:45 (at the age of 62 years old) as SINGLE DOSE for covid-19 immunization. The facility in which the vacation was given was a Pharmacy or Drug Store. Medical history included hypertension, blood cholesterol increased and covid-19 (prior to vaccination). The patient has no known allergies. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient 'was' diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 04Mar2021 at 00:00, The patient experienced flu like symptoms for 2-3 days, Pain chest, Neck pain, Arm pain and Pain. No Treatment was given. The clinical course was as follows patient had the normal flu like symptoms for 2-3 days. Then noticed that her neck arm and shoulder were killing me. Now it is the whole upper left quadrant of her body. This includes the chest area around where my heart is. It is very painful and I do cry out with a pain sound if I move a certain way. No treatment was given for the events. The clinical outcome of the event was not recovered. Information on the lot/batch number has been requested.
62 2021-04-06 heart flutter large flutter in my chest; This is a spontaneous report from a contactable consumer. A 62-year-old f... Read more
large flutter in my chest; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot number: EP6955, via an unspecified route of administration, administered in left arm on 20Mar2021 10:00 as single dose for covid-19 immunisation. Medical history was not reported. Concomitant medications included vitamin D3 and biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (MULTI B "BIOSYM"). On 20Mar2021, 7 hours after Covid vaccine, the patient experienced a large flutter in her chest, lasting about 5 seconds. It happened again after about 5 minutes. No treatment has been received. The outcome of the event was recovered on an unspecified date. Information about lot/batch number has been requested.
62 2021-04-09 lightheadedness I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; F... Read more
I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
62 2021-04-10 fibrin d dimer increased 2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days... Read more
2 days after i received the vaccine had difficulty breathing shortness of breath and on 5 and 6 days also then had chills hand tremors loss of appetite nausea this continued for 2 more months. I went to Urgent care and on March 26 then found a clot in my right lung. I am on warfin now and none of these symptoms did I have prior to the vaccine. I had 5 covid tests to see if I had COVID but all the tests were negative.
62 2021-04-11 troponin increased, pulmonary embolism Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19... Read more
Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19, then found obtunded due to pulmonary embolus resulting in death within 24 hours of receiving 2nd dose
62 2021-04-13 heart rate increased Extremely high heart rate that lasted for more then 8hours
62 2021-04-15 transient ischaemic attack Extreme dizziness and vomiting occurred 4/10/21. Diplopia and numbness began on 4/11/21 and continue... Read more
Extreme dizziness and vomiting occurred 4/10/21. Diplopia and numbness began on 4/11/21 and continued. MRI and CT scans confirmed that the patient experienced a transient ischemic attack (TIA) and Veretebral artery dissection (HCC) between 4/10 and 4/11.
62 2021-04-15 fibrin d dimer increased, chest pain Pfizer-BioNTech COVID-19 Vaccine EUA: six days after immunization patient presents with shortness of... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: six days after immunization patient presents with shortness of breath, myalgias, cough, headache, and chest pain. Hospitalized with acute hypoxemic respiratory failure secondary to COVID-19 infection: administered steroids, antivirals, and anticoagulation. Patient currently hospitalized.
62 2021-04-16 chest pain * On 4/2/21 - Fever 103.2, Fatigue, No appetite, Dizziness. * On 4/5/21 - Severe chest pain. Went t... Read more
* On 4/2/21 - Fever 103.2, Fatigue, No appetite, Dizziness. * On 4/5/21 - Severe chest pain. Went to ER. Transferred to clinic in. Admitted to clinic on 4/5/21: - Test: Ultrasound, Xray, Lab Tests, Electrocardiogram - Outcome: Pericardial enhancement adjacent to the left ventricle with no effusion - Treatment: Motrin 400 mg/4 times a day, Protonix 40mg/day to protect stomach
62 2021-04-17 atrial fibrillation After initial two days of side effects of temp and fatigue, nausea, continued side effects of extrem... Read more
After initial two days of side effects of temp and fatigue, nausea, continued side effects of extreme fatigue, nausea low grade temp for ten days, fatigue got worse; resulting in extreme shortness of breath. i went to the emergency room where i was diagnosed with AFIB. I spent 6 days in hospital. No previous condition of AFIB. An exam and physical in July did not reveal any health issues.
62 2021-04-17 loss of consciousness eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy ... Read more
eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
62 2021-04-17 heart rate irregular, loss of consciousness passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs... Read more
passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.
62 2021-04-17 chest pain, inflammation of the pericardium starting at 930 pm the day of vaccination I started to have SOB and chest pain. I tried to take 2 pu... Read more
starting at 930 pm the day of vaccination I started to have SOB and chest pain. I tried to take 2 puffs of my ProAir inhaler, this did nothing to help the SOB. Within the hour I could not get a full breath at all. the chest pain was only tolerable if I was leaning forward. My husband took me to the ER. They did testing and found that I had Pericarditis and Pleuritis. They informed me that I should NOT get any further COVID vaccines because it could kill me.
62 2021-04-18 nosebleed, haemoglobin decreased, chest discomfort Adverse reaction: Sudden severe shortness of breath when I exerted myself, severe constant headache ... Read more
Adverse reaction: Sudden severe shortness of breath when I exerted myself, severe constant headache that tylenol couldn't dull, fatigue and weakness, weak shoulders could keep them raised for more than a few seconds, swelling of abdomen, rapid fluid retention, lack of appetite, chest felt constricted, nose bleeds, black sticky stools Treatment: 2 units of blood, ferrouse sulfate IV, saline IV, protonix IV, endoscopy Outcome:health back to normal, after blood transfusion, will continue to take pantoprazole for six weeks and Iron Note: used to have ulcers years ago due to H. Pylori bacterium suspect Pfizer mRNA vaccine interacted with H. Pylori antibodies as has been found in other patients with H. Pylori.
62 2021-04-19 heart attack, cerebrovascular accident Resident was given the vaccine on 4/8/21. She had a stroke/heart attack when she was being taken to... Read more
Resident was given the vaccine on 4/8/21. She had a stroke/heart attack when she was being taken to the bathroom on 4/13/21 around 8:30pm. She was admitted to the hospital and at this time I believe she is still hospitalized. We were unsure if this was related to the vaccine or her general health condition as she is recently started dialysis and they discovered a pituitary cancer when doing a scan for the stroke on 4/13/21 or 4/14/21. We talked with our Medical Director and thought it would be best to report this since it happened shortly after her first vaccine dose.
62 2021-04-24 heart rate increased, palpitations, heart rate abnormal, heart flutter heart was fluttering and beating out of her chest; Elevated heart rate/The highest was 130; she felt... Read more
heart was fluttering and beating out of her chest; Elevated heart rate/The highest was 130; she felt her heart racing; Heart rate goes up and down; could not do anything and was laying in bed or on the couch; white blood cell count is higher than it should be; has allergies to medications but not what was in the Pfizer shot. She adds that maybe she had a reaction to the chemicals in there.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6206 and expiry date: was not provided), via an unspecified route of administration, in arm left, on 10Mar2021 at 03:30 PM, as a single dose for COVID-19 immunization, at hospital. The patient was not pregnant at the time of vaccination. The patient was tested for COVID-19, before the vaccination, however, results not provided. The patient has not been tested for COVID-19, after the vaccination. Patient's medical history included breast cancer survivor, chronic lymphatic leukemia. Patient had known allergies with penicillin and sulfa. Concomitant medications included calcium, colecalciferol (D3), macrogol 3350 (MIRALAX), multi vitamin, and ibuprofen (ADVIL DUAL). The patient previously took ciprofloxacin (CIPRO) and morphine: and had allergies with both drugs. The patient reported that on 11Mar2021, her heart was fluttering and beating it out of her chest with elevated heart rate which goes up and down. She also felt her heart was racing. It was very erratic. The highest heart rate was 130 (non-sustained). It was started since morning after the vaccination and was still happening now and wanted to know that it was a normal side effect. She had a cardiac work up and couldn't find anything however, everything was normal. Her heart rate went up to 130, 140, 150 and went to 80. This was happened over a period of 5 or 6 days. She felt like she could not do anything and was lying in bed or on the couch for three days. Her white blood cell count was higher that it should be. She went to her regular doctor who did the EKG, however, results not provided. Further, she went to a Cardiologist and they did another EKG and wore a monitor for a week and did echocardiogram and blood work all results were normal. She was wondering, if this could possibly be a side effect from the vaccine because it did occur in the morning after she got vaccinated. She also reported that she had allergies to medications but not what was in the vaccine and that maybe she had a reaction to the chemicals in the vaccine. She was supposed to get the second shot of vaccine which was scheduled on 31Mar2021 and had concerned about getting the second shot because she had some allergies and now this happened. She was very frightening and thought that she was going to die. It was very scary for her. The product complaint was not reported. The patient did not receive any treatment for the event. Outcome of the event Allergy to chemicals was unknown and for all other events it was recovered on an unknown date in Mar2021. No follow-up attempts possible. No further information expected.
62 2021-04-26 cerebrovascular accident had a stroke after getting the Pfizer vaccine; weakness left arm and left leg; Headache; Dural venou... Read more
had a stroke after getting the Pfizer vaccine; weakness left arm and left leg; Headache; Dural venous sinus thrombosis; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 62-years of age) dose 2 via an unspecified route of administration, administered in arm right on 01Apr2021 10:20 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation (to not get Covid). Medical history included ongoing multiple sclerosis which was diagnosed back in the early 90's and the doctors saw no new reasons on any part of the MRI of the brain, neck, and spine, there were no new lesion and she has had no problems for 30 years; and she had sinus pressure. There were no concomitant medications. Historical vaccine included BNT162B2 (Batch/lot number: EN6208) dose 1 in her left arm on 11Mar2021 (at 61 years of age) for COVID-19 immunisation. It was reported that the patient had a stroke after getting the Pfizer vaccine. She stated that she was in the ICU for 3 days. They tested every part of her body and couldn't find a reason. She added that she had a clot in her brain with a small bleed and they told her it was highly unusual to happen in that part of the brain. It was stated that it was where the blood goes from the brain to the heart. She mentioned that it was a dural venous sinus thrombosis. She was in the neuroscience ICU for 3 days and her left leg and left arm are still weak and she will start PT. She wanted to talk about reporting and let us know this was happening and that the neuroscience team reported it to the CDC online while she was in the hospital. She wanted to talk about her concerns and see if we are seeing this with other people. She added that she was tested, and they found nothing. She mentioned that she got the vaccine in a Thursday morning and by Friday she had weakness in her left arm and left leg and a headache. She added that there was a high probability that it was related, that it was a new vaccine and it was hard to say it definitely happened from that but it was a high probability. She had other questions, she has heard from other people with other vaccines and people with Covid experience blood clots. She stated that she was wondering what if it was with the vaccine that is reacting to what it thinks is Covid, or is it the body's response. She was wondering if Pfizer comes out with a booster with the variant, should she not take the booster. She stated that it could have killed her if they had not caught the blood clot in her brain and had she not gone to the ER it could have killed her and she was concerned about taking a booster. She provided that she had the Pfizer vaccine on 01Apr2021 in the morning and had a headache that same day and who knows when on Friday morning she had weakness in her left leg and left arm, so within 24 hours. She provided that she went to the ER Saturday 03Apr2021, that she wasn't sure about it and you don't go running for everything. Stated she was admitted 03Apr2021 and was discharged 05Apr2021 or 06Apr2021. She clarified that her headache was totally gone, that she had sinus pressure that was not related and had it as a constant in her life, it was normal for her and happens with changes with the weather. The patient was hospitalized for had a stroke after getting the pfizer vaccine (cerebrovascular accident) from 03Apr2021 to 06Apr2021. The patient underwent lab tests and procedures which included blood work constantly, CAT scan of her torso, several CAT scans of her brain, had MRI's and CAT scans constantly, brain MRI, MRV of the brain all on an unknown date with unknown results. The events resulted from Emergency Room Visit. The outcome of headache was recovered on an unknown date while not recovered for weakness left arm and left leg. The outcome of other events was unknown. Information on the lot/batch number has been requested.
62 2021-04-26 fainting, hypotension on the verge of fainting; blood pressure was was 82/48/blood pressure remained low; felt faint/extre... Read more
on the verge of fainting; blood pressure was was 82/48/blood pressure remained low; felt faint/extremely light-headed; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 19Jan2021 06:45 (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. Medical history included hypertension, diabetes (well controlled), and fatty liver disease. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide; olmesartan medoxomil (BENICAR); and omeprazole (PRILOSEC); and vitamin B complex. The patient previously took the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 28Dec2020 06:30 (Batch/Lot Number: EL1284) at the age of 62 years old as single dose for COVID-19 immunisation. On 20Jan2021 09:15, the patient experienced felt faint and extremely light-headed and on the verge of fainting. The patient laid down and then took her blood pressure. It was 82/48. Her blood pressure remained low throughout the day and did not return completely to normal until 3 days later. No treatment was received for the events. Outcome of the blood pressure was 82/48/blood pressure remained low was recovered on 23Jan2021 while of the remaining events was recovered on 2021.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of an association of the suspect drug administration with the reported events, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
62 2021-04-27 deep vein blood clot, blood clot Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee... Read more
Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.
62 2021-04-27 cardiac arrest My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. T... Read more
My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. The following morning at 7:00 am, Patient said that she felt real sick. She also, complained of having a real bad Headache, Not long after that, she felt like throwing up. She tried to throw up. Except, nothing came out and she felt very nauseous because of the vaccine. When she came call to bed, I offered to make her some breakfast to help her feel better. Unfortunately, she felt, too, I'll to try and eat an food because of the way she felt. So, I laid next to her with the hope that all would be well. Because, the pharmacist who administered the second dose. Assured my partner, that it was normal to feel flu like symptoms the next day. So, we never doubted what the pharmacist advised. All of sudden, she suffered a cardiac arrest in my presence and died in front of me.
62 2021-04-30 inflammation of the pericardium Pericarditis; Pleuritis; This is a spontaneous report from a contactable consumer, the patient. A 62... Read more
Pericarditis; Pleuritis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0162), via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 62-years-old) as a single dose for COVID-19 immunization. Medical history included thalassemia minor, fibromyalgia, migraines, depression, Barrett's Esophagus, hiatal hernia, restless leg syndrome (RLS), asthma, hypothyroidism, moderate sleep apnea, osteoarthritis, valvular heart disease, hyperlipidemia, degenerative disc disease (DDD), osteopenia, benign essential tremor, hypertension (HTN). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported, but the patient did receive other unspecified medications within two weeks of the vaccine. The patient did not receive any other vaccinations within 4 weeks of the vaccine. The patient previously took morphine, pregabalin (LYRICA) and methylphenidate hydrochloride (CONCERTA) and experienced allergies. On 15Apr2021 at 21:30, the patient had shortness of breath and chest pain and could only tolerate leaning forward. She went to the emergency room and was admitted to the hospital for pericarditis and pleuritis. She was informed not to take the second vaccine as it would kill her. The patient was hospitalized as of an unspecified date for 2 days and treated with steroids, anti-inflammatory and pain medication. Since the vaccination, the patient was tested for COVID-19 via nasal swab on 16Apr2021 with negative results. The clinical outcome of pericarditis and pleuritis was resolving.
62 2021-04-30 blood pressure increased blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85; really bad vertigo ... Read more
blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85; really bad vertigo and dizziness; really bad vertigo and dizziness; facial palsy; vision in her right eye got fuzzy; face got numb on the right side; hot electrical nerve zinging entire right arm, right shoulder blade and right calf; sore arm; feel sick; hangover; vomiting; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 16Apr2021 11:15 (Batch/Lot Number: EW0162) as single dose (at the age of 62-years-old) for COVID-19 immunisation. Medical history included anaphylaxis: carries an epi pen, and has allergies to wasps. The patient also took unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient got her first vaccine dose on 16Apr2021 and reported having a history of anaphylaxis and carried an epi pen. She stayed at the vaccination facility for an hour and a half and she got facial palsy and her vision in her right eye got fuzzy. Then her face got numb on the right side. It took 4 hours for it to go away but by dinner she felt ok. She added that immediately after the shot (16Apr2021), she experienced hot electrical nerve zinging entire right arm, right shoulder blade and right calf that lasted 30 minutes; blurry vision right eye started 15 minutes after shot, recurred off and on for 6 hours; facial palsy on right side that started about 30 minutes after shot that lasted 4 1/2 hours; vertigo/dizziness that started 7 hours after the shot; and blood pressure (BP) was usually 110/70 however 8 hours after shot BP was 145/85. She filed a report online when her symptoms began to subside. A couple hours later, she began to feel sick again and went to bed. When she walked to her mailbox, she was feeling ok but when she bent over to get the mail, that made it all worse. She woke up feeling as if she had a hangover and reported vomiting right away after getting out of bed. She had really bad vertigo and dizziness. She also had a sore arm (unspecified which arm) and stated that she was "experiencing everything on the freaking list." The patient wanted to know if this was normal and asked if she should get the second dose. She was advised that if she had a severe allergic reaction after a previous dose of the vaccine, she should not get the Pfizer-BioNTech Covid-19 vaccine. She also wanted to know if her symptoms got worse over the weekend and wanted to know what were the signs if she should go to the hospital. The patient did not receive any treatment for the adverse effects. The patient did not have COVID prior to vaccination and was not COVID tested post vaccination. The patient recovered from hot electrical nerve zinging entire right arm, right shoulder blade and right calf 16Apr2021 11:45; face got numb on the right side on 16Apr2021 15:15 and facial palsy on 16Apr2021 16:15. The outcome of the remaining events was unknown.
62 2021-04-30 fainting, hypotension felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell h... Read more
felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself). This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events. Information on the lot/batch number has been requested.
62 2021-05-03 loss of consciousness She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy;... Read more
She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy; body aches; She felt like she was on a boat/ she was not feeling right; had soreness in her arm; has zero energy; She fell asleep in her sunroom and got up around 3:00PM; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158; Expiration Date: Jul2021, NDC not known), via an unspecified route of administration, administered in right arm on 16Apr2021 at 10:00AM (at the age of 62-year-old) at single dose for prevent Covid 19, she wanted to feel safe traveling. No additional administered vaccines administered on same date with the Pfizer vaccine considered as suspect. Medical history included ongoing rheumatoid arthritis and prior to receiving her Covid 19 vaccines she reached out to her rheumatologist to see if she would be ok getting the Covid 19 vaccine while taking her medications, her rheumatologist told her she would be ok to receive the Covid 19 vaccine. Ongoing concomitant medications included methotrexate injection and hydroxychloroquine. No prior vaccinations within 4 weeks. The patient previously was made to get a flu vaccine for work about 20 years before for immunization, the flu vaccine made her violently ill, she ended up having to go to an Urgent Care, she had to call her mother to come get her, she could not even get out of bed, she had to stay home a week from work because she was sick; she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 (at the age of 61-year-old) at single dose for COVID-19 immunization and experienced fever, everything in her body ached, every time she bended over, if her head got below her shoulders to pick something up she would black out and vertigo. When she received her second Covid 19 vaccine her symptoms started again on 16Apr2021. She felt like she would pass out if she didn't feel the black out sensation coming on. She didn't know how long she blacks out for. She tried to grab a hold of something, for example, she was in the shower shaving her legs and she reached down to shave her legs and she could feel herself starting to pass out. She had a ledge or seat in her shower and she grabbed the shower wall and lowered herself to a sitting position on that ledge in her shower. The feeling passed and she tried to shave the other leg and the same thing happened again. When she's sitting on her sofa and she bended down to the floor to pet her small dog, all of a sudden she could feel herself moving forward like she was going to fall forward. Her husband grabbed her arm and pulled her to an upright position and asked her if she was ok. She reported her normal body temperature was 96.9 degrees Fahrenheit on an unspecified date. She was not someone who ran 98.6 degrees Fahrenheit. She reported her temperature had been about 98.8-98.9 degrees Fahrenheit on an unspecified date and that to her was a fever. She was still running a fever. She reported she had been afraid to drive because she was afraid she would pass out. She knew she did not have vertigo. She did a have a yearly check up with her primary care doctor and she was going to talk to her doctor about what's happening. She received her Covid 19 vaccine with her husband at about 10:00AM. Shortly after when she and her husband were driving home, she told her husband she was dizzy on 16Apr2021. She felt like she was on a boat. Even if she looked up or bent over was when she got dizzy. Her fever started right away after her vaccines on 16Apr2021. She also had soreness in her arm and everything in her body aches on 16Apr2021. She had zero energy on 16Apr2021. She was still feeling this way now. She fell asleep in her sunroom and got up around 3:00PM on 16Apr2021. Not any adverse events required a visit to Emergency Room nor Physician Office. The outcome of the event fell asleep was unknown, outcome of the other events was not recovered.
62 2021-05-06 chest pain vomiting; chest pain; stomach pain; nausea; chills; body ache; stomach pain more intense; acute panc... Read more
vomiting; chest pain; stomach pain; nausea; chills; body ache; stomach pain more intense; acute pancreatitis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER2613, second dose) solution for injection intramuscular in the left arm on 23Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included ARMD (age-related macular degeneration), high blood pressure, and anxiety. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and AREDS vitamins. The patient had no known allergies. Historical vaccine included BNT162B2 (first dose, lot EN6202) for COVID-19 vaccination on 02Mar2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 at 07:00, the patient experienced stomach pain, nausea, chills, and body ache. On 26Mar2021, the patient experienced vomiting and chest pain. In Mar2021, the patient experienced acute pancreatitis and stomach pain more intense. The events resulted in emergency room/department or urgent care visit and hospitalization for 10 days in 2021. Lab test in Mar2021 included CT scan: revealed acute pancreatitis. Treatment for the events included antibiotics, fluids, and oxygen. The outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.
62 2021-05-11 blood pressure increased Her blood pressure went over 220; Migraine; Her balance was off as well; She has been experiencing e... Read more
Her blood pressure went over 220; Migraine; Her balance was off as well; She has been experiencing excessive hot flashes; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included hot flush. The patient's concomitant medications were not reported. Patient mentioned that about 45 minutes after getting it, her blood pressure went over 220. Her normal blood pressure is 132/72 or 74 or 76. After she was released from the ER in the hospital, they asked her to take migraine medications for the migraine she has experienced afterward in Apr2021. She mentioned that she cannot get rid of the migraine and she has been experiencing excessive hot flashes, more than what she was having before. Her balance was off as well. She was asking if this has been reported and for what to do. She was also asking if this will most likely happen during her 2nd shot as well as she was not looking forward to it. She has consulted several doctors already. Patient still have a migraine that has been ongoing for 2 weeks and states it's "not a fun thing." She states she spoke with a neurologist who has gotten phone calls from people who have received Pfizer's and other's COVID-19 vaccines and are experiencing "headaches for days." Caller states that there was nothing medically wrong with her. She states that her blood pressure "never spiked" like that before. She reports that she has taken migraine medication and Percocet for the headaches and was also prescribed Prednisone as a "hope to try to get rid of the headaches." Outcome of the event migraine was not recovered, whereas unknown for other events. Follow-up attempts are completed. Information about lot/batch number cannot obtained.
62 2021-05-11 palpitations, blood clot To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; ... Read more
To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.
62 2021-05-12 fainting, hypertension having faint spells; blood pressure is a little bit higher than normal; Feeling kind of funny; had s... Read more
having faint spells; blood pressure is a little bit higher than normal; Feeling kind of funny; had severe headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8727, second dose) solution for injection intramuscular in the left arm on 25Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disease (diagnosed with probably 20-21 years ago) and blood pressure increased (takes blood pressure medicine). Concomitant medication included hydrochlorothiazide for blood pressure increased began taking this 4 or 5 years ago. Historical vaccine included BNT162B2 (first dose, lot EN6200) for COVID-19 vaccination on 04Mar2021 with no adverse effect reported. On 25Mar2021, the patient was feeling kind of funny and had a severe headache. In Apr2021, the patient had faint spells and blood pressure was a little bit higher than normal at 137/80 which began after the second dose Pfizer Covid Vaccine. The patient stated she never felt like fainting before in her life. Her blood pressure was never over 150 and can't keep blood pressure under 130 for some reason. The outcome of the events feeling kind of funny and headache was unknown. The outcome of the events faint spells and blood pressure was a little bit higher was not recovered. Information on batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event faint spells and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-01-03 chest discomfort, hypertension Tightness on the chest Blood Pressure was high 185 or 198 Dry Mouth Hard time to breath After 1 ho... Read more
Tightness on the chest Blood Pressure was high 185 or 198 Dry Mouth Hard time to breath After 1 hour I started itching
63 2021-01-06 hypertension, fainting HYPERtension, Syncope Hx. HTN and did not take BP meds in the morning. also anxious about immuniatio... Read more
HYPERtension, Syncope Hx. HTN and did not take BP meds in the morning. also anxious about immuniation. Narrative: History of recent stress test with pending results. pt. c/o lightheadedness while seated in recliner during observation. Per pt., she feels anxious after witnessing another person have a syncopal event. BP 240/98, P 76, R 22, O2 sat. 99% at 0935. RRT in the area so they assessed the pt. and convinced her to go to ED to be checked out. D/c'd per w/c to the ED with RRT. ED reported BP 190/108 in the ED. States she did not take BP meds in the morning and was anxious about her immunization today. ED reported she took her Losartan at 4pm. Discharged from the ED. Recorded on employee medical file on database.
63 2021-01-06 fainting Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, c... Read more
Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency. Tested + for COVID on 1/4/21 Narrative: Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency, sees hematology. Currently taking prn tylenol, scheduled to see hematology. Tested positive for COVID on 1/4/21.
63 2021-01-07 blood pressure increased 20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness... Read more
20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness. BP 151/93, 10 minutes later BP 130/83. Severe Dizziness and intense anxiety attacks commenced within 24 hours and lasted for 7-8 days. These were accompanied by sensation of pressure in brain and headache. Treatment with hydroxyzine 25mg once or twice a day reduced intensity of anxiety attacks but did nothing to help with the dizziness. Headaches were intermittent during this period. Almost all dizziness subsided by day 12 post vaccine. Headaches subsided by day 5.
63 2021-01-07 heart rate increased heart rate in the 120's which last 15 minutes while at rest; Left arm deep aching; This is a spontan... Read more
heart rate in the 120's which last 15 minutes while at rest; Left arm deep aching; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in the left arm on 30Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included pulmonary embolism (PE's x 2) and left nephrectomy for kidney cancer (CA). Concomitant medications included apixaban (ELIQUIS), losartan and hctz. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020 18:00, the patient experienced heart rate in the 120's which lasted 15 minutes while at rest and left arm deep aching for 2 days. Outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
63 2021-01-09 fast heart rate Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine... Read more
Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine was administered. The tachycardia resolved without medical intervention within 2 minutes. The remainder of the symptoms remained the rest of the day, along with profound fatigue and intermittent self limited tachycardia. The headache was managed with Tylenol. I slept most of the day and through the night. The following day, I had a headache, which was mild. Fatigue remained. I also noted intermittent tachycardia with mild exertion, self limited, less than 1 minute. Mild soreness at injection site.
63 2021-01-10 chest discomfort Three hours after the vaccine I started developing chest pressure that lasted 45 minutes. After an h... Read more
Three hours after the vaccine I started developing chest pressure that lasted 45 minutes. After an hour after I had disnea rest which last 55 hours. I put a call into my patient care provider and went it to get a Coivd test that came back negative. I was told If it got worse to go to the emergency room . After the 55th hour I was back to normal.
63 2021-01-11 blood pressure increased Blood Pressure shot up to 170/100. took 3 hours to return to normal.; This is a spontaneous report f... Read more
Blood Pressure shot up to 170/100. took 3 hours to return to normal.; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), via an unspecified route of administration in the left arm on 05Jan2021 07:00 at a single dose for covid-19 immunization. Medical history included arthritis, allergy to plants and arthropod sting. the patient was not pregnant at the time of the reporting. The patient's concomitant medications were not reported. On 05Jan2021 07:00, the patient's blood pressure shoot up to 170/100. It took 3 hours to return to normal. The outcome of event was recovered. No treatment was required/given due to the event. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
63 2021-01-11 fast heart rate Tachycardia, shortness of breath, and nausea with second dose of Pfizer-BioNTech COVID-19 vaccine 0.... Read more
Tachycardia, shortness of breath, and nausea with second dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. vitals stable. Monitored in clinic for 1 hour and then sent to ED for further evaluation. ECG normal. Patient able to discharge in stable condition.
63 2021-01-12 palpitations 11:45: C/O: HEART RACING REALLY FAST. EMS ON SCENE. VS: 02 SAT R.A.: 97%; P: 72; BP: 159/90 (... Read more
11:45: C/O: HEART RACING REALLY FAST. EMS ON SCENE. VS: 02 SAT R.A.: 97%; P: 72; BP: 159/90 (FSBS: 257); 12:00 SYMPTOMS IMPROVED- VS: 144/73; P: 68; LEFT FACILITY, NO COMPLAINTS
63 2021-01-12 nosebleed After the Pfizer injection I started to have a nose bleed, I saw ER doctor in place of my work, who ... Read more
After the Pfizer injection I started to have a nose bleed, I saw ER doctor in place of my work, who examined me and told me that the room I was in was so dry and that my allergies were getting bad. I am scheduled to have my second dose 01-14-2021.
63 2021-01-12 cerebrovascular accident She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face ... Read more
She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face weakness. She did recover fully. She already has known CAD and risk factors for CVD. It is possible, but by no means certain, that the vaccine was an indirect cause of the event. Since the vaccine provoked an immune response, as it was supposed to, it is possible that this inflammation may have set up a metabolic predisposition that may have contributed to the event, which was 12 days later.
63 2021-01-13 lightheadedness 30 seconds of near syncope
63 2021-01-13 deep vein blood clot Developed DVT in left leg around January 9. Developed pain, redness and swelling in left calf
63 2021-01-15 chest discomfort, palpitations, chest pain Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I w... Read more
Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I was taken to the Emergency Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed prednisone and Benadryl. I was diagnosed with Anaphylaxis.
63 2021-01-16 hypertension 2.5 hours after receiving vaccine, I started getting dizzy and vomiting. I vomited 6 or 7 times. I w... Read more
2.5 hours after receiving vaccine, I started getting dizzy and vomiting. I vomited 6 or 7 times. I was so dizzy I couldn't open my eyes without getting sick. We called ER and explained that we thought I was having a reaction to the vaccine, and their response was they had never heard of that type of reaction. I was sick all night, called my primary Dr in the am and they told me to go to ER. We had to call ambulance to take me there because I was so sick and couldn't open my eyes without having to vomit. Room spun in circles. My arrival at ER, they did MRI, EKG, blood work. My blood pressure was very high, so they connected me to a heart monitor. I had low Magnesium due to vomiting so much. I was treated with Valium and anti-vert medication and fluids. I stayed overnight in hospital- had PT Jan 13th for DX of Vertigo. Then referred to Outpatient PT for Vertigo. Dr's felt it was a "coincident" that I got Vertigo shortly after vaccine, and strongly felt it was not related. . Today is Jan 17th, and I am still dizzy, but feeling better. I have an appointment with my primary Jan 18th and not sure if I should take the 2nd dose. That is the question.
63 2021-01-17 chest pain, chest discomfort Severe chest pain ( like a vice was tightening around chest). Lasted 20-25 minutes. No nausea. Had... Read more
Severe chest pain ( like a vice was tightening around chest). Lasted 20-25 minutes. No nausea. Had to go to ER, Labs all negative, could find no reason for pain. Went home after approximately 3-4 hours in ER. Also arm pain x 1 month now
63 2021-01-20 chest discomfort, heart rate increased itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight ... Read more
itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.
63 2021-01-21 chest discomfort I was okay during the 30 minute observation period, and was discharged. Between 1 and 1:30 am, abou... Read more
I was okay during the 30 minute observation period, and was discharged. Between 1 and 1:30 am, about 15 hours after receiving the vaccine, I woke up from my sleep suddenly, with an acute episode of chest tightness, cough, severe running nose and lacrimation. I did not have hives or lip/throat itching or swelling. I felt a little warm in the face. I took Ventolin inhaler two puffs twice 30 minutes apart + Aller-flo nasal sprays. I began to feel a bit better and then took Benadryl 25 mgms (because of my history of Angioedema) around 2:30 am. I feel better now, which is 12 hours after onset of episode, but had to take Ventolin inhaler this morning for a bit of chest tightness. I do not have a history of asthma, but have had seasonal allergies in past years. But if this is seasonal allergy, it is very unusual, since I have never had an acute episode like this without any early milder symptoms. And I haven't needed Ventolin in a couple of years. I am now concerned about taking the second dose.
63 2021-01-22 heart rate increased, hypertension Throat and back of tongue swelling, hot flushes in head and face. High blood pressure and pulse.
63 2021-01-24 heart rate increased Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, s... Read more
Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.
63 2021-01-25 chest discomfort lost a lot of weight, but still plump; tightness in chest; Upper chest tightness with post nasal dri... Read more
lost a lot of weight, but still plump; tightness in chest; Upper chest tightness with post nasal drip, like the flu; got Covid virus/ Covid PCR testing: positive; got Covid virus/ Covid PCR testing: positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EJ1685) via an unspecified route of administration on left arm on 24Dec2020 11:00 at single dose for COVID-19 immunisation. Medical history included ongoing asthma, ongoing allergies. She was asthmatic and believed that the virus would have affected her differently if she didn't get the vaccine. If she was to catch the virus and didn't have the vaccine she may not have come out of it. The patient's concomitant medications were not reported. The patient denied getting any other vaccines that day or 4 weeks prior. No problems with vaccines in past. Received the COVID vaccine at her workplace. The patient got COVID virus on 07Jan2021. It was also reported that the patient lost a lot of weight, but still plump, coughing, tightness in chest, upper chest tightness with post nasal drip, like the flu, body aches, all on an unspecified date. Emergency room visit needed for the events (body aches, runny nose). The patient underwent lab tests and procedures which included Covid PCR testing: negative on 04Jan2021, positive on 07Jan2021, rapid COVID testing: negative on 01Jan2021. The outcome of the event (got COVID virus) was not recovered, of other remain events was unknown. Clinical course: The patient received the first dose of BNT162B2 on 24Dec2020, and a couple weeks later she got the COVID virus (07Jan2021). Mentioned she lost a lot of weight, but still plump. Probably be in the hospital now. Still had some coughing, tightness in chest, but it's not as bad. Upper chest tightness with post nasal drip, like the flu, runny nose in throat that goes down into the lungs and when it goes down she coughs and hacks to get rid of it. Went to the doctor office on the 01Jan2021 and did a rapid test and it was negative. Then on 04Jan2021 she did another PCR Covid test and it was negative. On 07Jan2021 she had symptoms and was insistent on getting another test since having body aches, runny nose. Got the re-test and it came back positive when she went to the emergency room. Got the PCR test. The patient thought that the way they were testing is how it's spreading. Did the testing on the 04Jan2021 and they used a swab bigger than a cue tip, it was huge and couldn't get far up enough instead of the tiny ones. On the 07Jan2021 at her job, emergency room, they had the tiny ones and was able to go further up and that's when she tested positive. Mentioned using salbutamol (ALBUTEROL) nebulizer, over the counter cough syrup, prescription azelastine hydrochloride;fluticasone propionate (DYMISTA) nasal spray, and pseudoephedrine hydrochloride (SUDAFED). When has the dry cough she uses the ALBUTEROL nebulizer with the machine and vials at home and that slows down the coughing a lot and the other stuff with the lungs. Not taking any steroids. Using SUDAFED to stop the runny nose from post nasal drip from going into lungs.
63 2021-01-26 chest pain About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking ... Read more
About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking for a tums. I didn't have any. I asked a coworker because my chest felt like I had heartburn. It was really bad. Protonic - a coworker gave it to me to see if that would help. And I took it. Diaphoretic - sweating - coworker noticed that I was sweating. I had pain in my jaw. I thought I was showing signs of a heart attack. A doctor came over and we told her what was happening with me. He recommended that I should be seen right away. Next thing I know, nurse is wheeling me down to ER in wheelchair as my chest pains weren't going away but ER told me I had to go through triage and wait. Finally got seen and I had an EKG - which was good. CDU unit - was admitted to and checked Troponin levels and did blood work. Everything came back fine. My EKG was being monitored all night. At one point I was feeling something and they gave me a dose of Nitro. It gave me a headache. There all night and then I did a stress test in the morning. And I was released that day. That was my day off so I was off all work. I went back to the work the day after. My granddaughter came to stay with me over Christmas and she started having symptoms of COVID. She wasn't feeling well. /She tested positive.Symptoms for COVID began for me on December 26th and was tested for COVID on December 27th - cough; sore throat; headache, fever, not got chills or lose my taste or smell (until after those symptoms were finished); belching - lots; diarrhea; upset; nausea. Extremely tired and muscles aches, joint pain - settled in my lower back and my hip. I still struggle with those joint pain and tiredness today. They put me off work until January 12 2021. I was scheduled to get the dose 2 at 9th but didn't get it that day because of COVID illness.
63 2021-01-27 loss of consciousness Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been ... Read more
Patient received her vaccine on Thursday, 1/21/21. From then until Saturday afternoon she had been experiencing extreme fatigue. On Sat. around 5:00 PM she was standing at her flat-top stove cooking dinner. A wave of very extreme fatigue came over her, so she leaned over to turn off the burner. When she did this, she passed out leaning forward with her hand on the burner and touching the frying pan. When she came to, she went to the couch and laid down - not realizing for 10 minutes that her hand and right breast were burned. The resulting injuries lead to her having to see her PCP on Monday, and then a General Surgeon on Weds 1/27/21. Injuries sustained include a second degree burn on her right breast, On the right arm, laterally above the wrist is a small superficial partially healed burn. On the dorsal aspect of the right fifth finger there is a longitudinal burn that goes from the MCP joint to almost the tip of the finger. She has limited range of motion due to discomfort and swelling. The blister encompasses the entire dorsal lateral aspect of the finger. The fourth right finger has a less extensive blistered area on the PIP joint. The burn on the fifth finger is deep second degree.
63 2021-01-28 chest pain, chest discomfort 8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest... Read more
8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-01-28 chest discomfort Chest "fullness" going up to neck and head. BP 141/82 Pulse 83 O2 98% R 18 Assessed by APN at time... Read more
Chest "fullness" going up to neck and head. BP 141/82 Pulse 83 O2 98% R 18 Assessed by APN at time of incident. Pt declined ER. Will follow up with PCP
63 2021-01-28 chest discomfort, oxygen saturation decreased heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing h... Read more
heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing heaviness in chest/Shortness of breath; difficulty breathing heaviness in chest/ heaviness in chest with right flank pain; Chills; Sensitive skin; Super Thirsty; Fever 100.7/Low grade fever 99.9/ Low grade fever 99.0; Joint Pain; Congestion; Right arm injection site severe pain; This is a spontaneous report from a contactable other healthcare professional (Patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 06Jan2021 10:30 at single dose in Right arm for COVID-19 immunization. Medical history included hypertension. Concomitant medication included benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ, 10-12.5 MG Tablet), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER). The patient previously took codeine and experienced allergy. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient did not have covid-19 tested post vaccination. On 06Jan2021 20:00, the patient experienced Fever 100.7, Joint Pain, Congestion, Right arm injection site severe pain. On 07Jan2021, the patient experienced Chills, Fever 100.7, Sensitive skin, Super Thirsty. On 08Jan2021, the patient had Temperature 98.8, No Chills, Thirsty. On 09Jan2021, the patient was Some relief, no fever, no chills, no joint pain. On 10Jan2021, the patient experienced low grade fever 99.9, Pulse oximeter 89%, difficulty breathing heaviness in chest. On 11Jan2021, oxygen was 92%, Low grade fever 99.0. On 12Jan2021, vital signs stable no fever 97.7, oxygen 96%. On 13Jan2021, Vital Signs stable. On 14Jan2021, the patient experienced Shortness of breath, heaviness in chest with right flank pain, lots of phlegm, Temperature 98.0, Oximeter 96%. Coricidin HBP taken to relieve Congestion. Therapeutic measures were taken as a result of all reported events. The outcome of event chills was recovered on 08Jan2021, outcome of event Fever (event onset date: 06Jan2021 20:00) was recovered on 09Jan2021, outcome of event Low grade fever (event onset date: 10Jan2021) was recovered on 12Jan2021, outcome of event Joint Pain was recovered in Jan2021. The outcome of the other events was recovering.
63 2021-01-28 pallor starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved -... Read more
starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved - now dizzy when standing; fatigue - arms feels heavy when taking shower; pale; remains very weak and tired; dizzy - feels like anemia - tried to work last night but broke out in cold sweat and pale so sent home from work last night - sxs are not worsening
63 2021-01-29 fainting Pt received her 2nd dose of the pfizer vaccination on 1/29/2021 and 5 hours later, developed a fever... Read more
Pt received her 2nd dose of the pfizer vaccination on 1/29/2021 and 5 hours later, developed a fever of 102F, muscle aches and had a syncopal episode.
63 2021-01-31 loss of consciousness Patient reported feeling dizzy and passed out at home when she was alone. She was able to call a fri... Read more
Patient reported feeling dizzy and passed out at home when she was alone. She was able to call a friend when she woke up. The friend came to pick her up and drove her to the patients primary care physician. The physician found all labs and vitals to be normal and told the patient to return home and rest.
63 2021-02-03 heart rate abnormal 1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,... Read more
1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,nausea,chills 4th day - headache, chills and feeling hot, nausea,skin rash , itching, tired,aches 5th day - headache,chills and feeling hot, nausea,rash and uncontrollable itching, tired.
63 2021-02-03 hypertension 8:20 pm - Patient received Pfizer COVID-19 dose 2 vaccine at 3:41 pm. Came in to c/o severe headache... Read more
8:20 pm - Patient received Pfizer COVID-19 dose 2 vaccine at 3:41 pm. Came in to c/o severe headache, dizzy, vomiting, and chills. BP high initial 176/81 P: 76, 97.7, O2: 99%. Patient has hx of HTN ans took medicine in the am. IMT called 8:25 pm, assessed vitals retaken (BP: 189/84; P:82 right arm; BP: 188/86, P: 82 left arm, and transported via wheelchair to Emergency Center for evaluation.
63 2021-02-10 chest discomfort Very sore arm Tightness in high chest, near collarbone only on right side Felt like I needed to co... Read more
Very sore arm Tightness in high chest, near collarbone only on right side Felt like I needed to cough but couldn?t. No true shortness of breath.
63 2021-02-10 heart rate increased, hypertension my lips were tingling followed by naushia , high blood pressure and heart rate. the ambulance was c... Read more
my lips were tingling followed by naushia , high blood pressure and heart rate. the ambulance was called i was then transported to hospital. where i had two sezuires. i was given adavan and sent home. with the instructions i was not allowed to have a follow up shot
63 2021-02-11 cardio-respiratory arrest Left side swelling to include face, arm, hand, trunk, legs and feet. Noted to be +3 pitting edema. ... Read more
Left side swelling to include face, arm, hand, trunk, legs and feet. Noted to be +3 pitting edema. On 2/5 @ 1307 start having seizure activity that lasted for over 20 minutes. Per hospital policy code blue was called. This resulted in an ER send out.
63 2021-02-11 chest discomfort pt c/o of chest pressure @ 1510. chief called at 1514. ems/911 arrived at 1527. pt axox3. no loc. @... Read more
pt c/o of chest pressure @ 1510. chief called at 1514. ems/911 arrived at 1527. pt axox3. no loc. @ 1514 bp 130/70. hr 79 RR 18. o2 96% RA. pt assessed and observed for 15 min for reaction. EMS did EKG in ambulance. pt signed out AMA. drove off in personal vehicle.
63 2021-02-14 chest discomfort Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild... Read more
Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild headache; pain in my toes feeling like they were broken; chills; sweating. Lasted from 3-7 pm although 4-7 I was in a sound sleep but aware of the symptoms I was feeling. It was a very unusual feeling of unconscious then conscious delirium feeling.
63 2021-02-15 chest pain Chest pain and burning in the chest and lungs, body aches, diffuse joint pain, and body stiffness
63 2021-02-15 chest pain My body was stiff and sore all over, for about 3 days ran fever 100.7 couldnt go to work 24 hours ,... Read more
My body was stiff and sore all over, for about 3 days ran fever 100.7 couldnt go to work 24 hours , and chest pains for 5 days and unable to lay on side while sleeping chest was enflamed, shortness of breath
63 2021-02-16 fainting Experienced syncopal episode following vaccine. Epinephrine 0.3mL administered by EMS at site.
63 2021-02-17 heart rate increased This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.
63 2021-02-17 palpitations tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen fe... Read more
tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious. No follow-up attempts are possible. No further information is expected.
63 2021-02-18 blood pressure increased Patient felt light headed
63 2021-02-18 chest discomfort Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), ... Read more
Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), thumb pain, brief leg "heaviness" (both) and fatigue, brief RLQ pain, increased tinnitus. The next evening: low back and neck (bone?) pain while attempting to sleep, out of character to usual back pain. By day 3 post injection, left nose tingling similar to onset of cold sore, which included left side of mouth the next day. By 7 days post injection, entire mouth area felt tingly similar to Novocaine wearing off. This lasted 3 days. Now improved. (took B-12 p.o.) Other brief episodes of chest discomfort, gum irritation, and anxiety. Vaccine #2 scheduled for 2/19/2021
63 2021-02-22 nosebleed, chest discomfort, chest pain 2/9 NEXT DAY IN AM 99.7 FEVER; SORE ARM MUSCLE TO MOVE ARM. 2/10 DAY TWO 48 HRS 3-6:00PM TIGHT BU... Read more
2/9 NEXT DAY IN AM 99.7 FEVER; SORE ARM MUSCLE TO MOVE ARM. 2/10 DAY TWO 48 HRS 3-6:00PM TIGHT BURNING CENTER CHEST PAIN TOOK TYLENOL; WATER. 2/11 DAY 3 - TIGHT BURNING CHEST PAIN INTERMITTENT ALL DAY - TOOK TYLENOL; HYDRATED WITH WATER. 2/12 DAY 4 - NO DISCOMFORT; GOT COVID TEST TO RULE OUT - NEGATIVE. 2/13 DAY 5 TIGHT CHEST PAIN 1:00PM TOOK TYLENOL SUBSIDED ONE HOUR. 8:00PM BLOODY NOSE 30 MINUTES. OK THERE AFTER.
63 2021-02-22 chest discomfort, palpitations Client received dose of vaccine at approx 1225. Was sitting in parking lot for monitoring. Summone... Read more
Client received dose of vaccine at approx 1225. Was sitting in parking lot for monitoring. Summoned attendance d/t report of heart racing, slight SOB, "weird feeling in chest". RN and NP were called. By their arrival, pt reported s/sx beginning to resolve. At 1240 BP 100/78, HR 72. At 1250: BP 100/78, HR 80. At 1300: BP 108/70, HR 72, R 18. Pt was instructed to go home and rest. Was allowed to leave site. RN called pt at 1435. Pt reported all symptoms had resolved. Was doing fine. RN
63 2021-02-23 pallor Patient received 2nd dose of Pfizer COVID vaccine. Blanching, erythematous, somewhat serpiginous ras... Read more
Patient received 2nd dose of Pfizer COVID vaccine. Blanching, erythematous, somewhat serpiginous rash to L arm and hand with blister present on medial aspect of proximal forearm. Not pruritic, not painful. Area with blister is tender to the touch. Rash is not present on the L shoulder, R arm, or back. Denies fevers. 2nd dose of COVID vaccine to L arm last Thursday. The rash seems to originate from the vaccination site and does not extend upwards. The rash was noticed only today during an office visit. Patient has an intellectual disability, and very independent. always wears a long sleeve and her caregivers had not noticed it until today when rash extended down to her hands below the long sleeve.
63 2021-02-23 skin turning blue, heart rate increased, fast heart rate The injection was at 10:06am. At 10:07am felt nauseated and dizzy. Waited 15 minutes before proceedi... Read more
The injection was at 10:06am. At 10:07am felt nauseated and dizzy. Waited 15 minutes before proceeding home. At 10:31am throat began to close and tongue became swollen. Lips and gums were numb. Breathing became difficult as was swallowing. Rapid heartbeat. Called 911. Pt was taken to the hospital. Administered Benedryl and possibly a steroid. Stayed overnight in the hospital.
63 2021-02-24 chest pain, heart rate increased Lasting effects are increased heart rate, itching, hematomas, head pain, chest pain and heavy lungs
63 2021-02-25 chest discomfort (2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST... Read more
(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST AND IT IS NOTED THAT PATIENT HAS PREVIOUS ISSUES WITH FLU SHOT WITH A HISTORY OF TORUBLE BREATHING. TEACHING IS PROVIDED WITH PATIENT REGARDING POSSIBLE SIMILAR REACTIONS WITH COVID-19 VACCINE AND THAT SHE SHOULD STAY AT LEAST 30 MINUTES AFTER VACCINATION IF SHE WISHES TO PROCEED. PATIENT CONSENT TO PROCEED WITH COVID-19 VACCINATION. VACCINE IS GIVEN AT 1000 INTO RIGHT ARM AND PATIENT IS ASKED TO STAY FOR OBSERVATION. AT 1030 PATIENT REPORTS TO THIS NURSE ITCHING AND HIVES. PATIENT IS OBSERVED TO HAVE HIVES COVERING BILATERAL ARMS AND CHEST. PATIENT DENIES BREATHING TROUBLE AT THIS TIME. EMERGENCY REACTION KIT IS BROUGHT TO PATIENT?S TABLE. AT 1032 ON CALL PROVIDER IS NOTIFIED OF REACTION AND ORDERS ARE GIVEN FOR BENADRYL 50MG IM. THIS IS GIVEN AT 1034 RN INTO GUTEAL AND PATIENT IS OBSERVED AND VS OBTAINED. AT 1040 PATIENT STATES HER THROAT FEELS ?SCRATCHY? AND ?TIGHT.? IT IS RECOMMENDED TO PATIENT SHE SHOULD BE SEEN IN THE EMERGENCY ROOM. PATIENT AGREES TO THIS IF SHE IS ABLE TO DRIVE HERSELF. PATIENT IS FOLLOWED IN HER VEHICLE TO EMERGENCY ROOM FROM OFF-SITE CLINIC (APPROX. 8 BLOCKS). ON CALL PROVIDER IS NOTIFIED AND HOSPITAL EMERGENCY ROOM IS GIVEN REPORT FROM THIS NURSE. UPON ARRIVAL TO ER PATIENT IS SEEN PER MD. PATIENT REPORTS SYMPTOMS OF CHEST PRESSURE, DYSPNEA, LIGHT HEADEDNESS, ABDOMINAL PAIN, RASH, REDNESS, WARTHM AND ITCHING. PATIENT IS GIVEN 0.4 MG SUBCU ADRENALINE AND 40 MG PREDNISONE ORALLY. PATIENT IS OBSERVED IN EMERGENCY ROOM x 1 HOUR. PATIENT REPORTS SHE IS STARTING TO FEEL BETTER. PATIENT IS DISCHARGED TO AT 1206 FROM EMERGENCY ROOM.
63 2021-02-25 hypertension Dizzy short of breath hypertensive
63 2021-02-25 chest discomfort, chest pain Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Detai... Read more
Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Patient stated she was experiencing some \"pressure and swelling under her upper ribcage\" and that she has had this reaction in the past when she accidently inhaled some chemicals. Patient was given one dose of Epinephrine IM into her left thigh and felt relief in pressure after 3 minutes. Patient was advised that if she experiences other symptoms to go to the ER.
63 2021-02-25 heart rate increased anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning s... Read more
anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on 20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.
63 2021-02-26 fibrin d dimer increased Cold chills, diarrhea, vomiting, shortness of breath, muscle soreness, light headed
63 2021-02-26 blood pressure increased Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific.... Read more
Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific. Went to be early at 9:30 and awoke at one a.m.on February 26 with splitting headache. Could not get back to sleep well and felt terrible all that day with headache, nausea, and foggy thinking, not funcional after about 2:30 p.m. Took Ibuprofen at 3 p.m., called doctor and went to ER at Medical Center. Was seen at ER a few hours later. Slept some in waiting room. Had sore throat, the worst splitting migraine type headache ever, and was extremely foggy headed, couldn't process thoughts, eyes had difficulty focusing, nausea. My temperature was a little high for me, I am normally low and it was 99. My blood pressure is usually low and it was 105/59, pulse was 82 and respiration was 16 with 96 % Oxygen Saturation. They did tests and had an ophthalmoligist give me an exam also. They said I could go home with the same meds they were giving me in the hospital since they were working to alleviate my painful headache, 600 mg of ibuprofen, reglan and benadryl. Before I left they gave me the potassium chloride. I am continuing my medications today, two days after my vaccine.
63 2021-02-28 chest discomfort, hypertension PATIENT HAD A SEVERE ALLERGIC REACTION TO THE VACCINE. A COUPLE OF HOURS AFTER THE VACCINE, SHE HAD ... Read more
PATIENT HAD A SEVERE ALLERGIC REACTION TO THE VACCINE. A COUPLE OF HOURS AFTER THE VACCINE, SHE HAD SHORTNESS OF BBREATH, CHEST TIGHTNESS, NAUSEA AN VOMITING, FACE NUMBNESS AND TINGLING, AND HIGH BLOOD PRESSURE.
63 2021-02-28 palpitations heart start palpitating and racing; kind of warm; This is a spontaneous report from a contactable co... Read more
heart start palpitating and racing; kind of warm; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 26Jan2021 11:00 at a single dose for Covid-19 immunization, and potassium chloride ER, via an unspecified route of administration from an unspecified date at 10 mg, daily (every day) for low potassium. Medical history included anxiety and was afraid to take her anxiety medicine; hypertension, and iron deficiency; all from an unknown date. Concomitant medications included amlodipine besilate (NORVASC) for hypertension, and colecalciferol (VITAMIN D [COLECALCIFEROL]). It was reported that when the patient got the shot it did not hurt but when she sat down for about a minute (26Jan2021), her heart start palpitating, and racing and then she got kind of warm and then it went away. She didn't pass out, had no shortness of breath. She just wanted to know if it was one of the side effects and that's why she need to report this. The patient was looking at the ingredients that Pfizer have like potassium and stuff. The patient takes potassium every day. She added that maybe she should have not taken her potassium at the same day, would make your heart raise that's why she was wondering. Otherwise the patient felt fine. She just needed to report this. Furthermore, patient stated that maybe because she was nervous, she was scared to take certain anxiety medicines (unspecified medications) she did not know would had it though. The outcome of the events was recovered.
63 2021-03-01 chest pain I woke up at 2 am to intense chest pains. They radiated from my left shoulder blade through to my le... Read more
I woke up at 2 am to intense chest pains. They radiated from my left shoulder blade through to my left breast. Pain was worse when I breathed. I at first suspected indigestion, so sat on couch, took an antacid and that did not help. My husband awoke at 4 and gave me 3 baby aspirin which helped some what. Laid down for awhile, woke about 10 am to severe pain. Ended up in the emergency room at noon thinking it was a heart attack. My blood pressure was only slightly elevated and I have no history of heart problems. At the hospital all heart related tests came back okay. I was given morphine for pain and zofran. The medicine helped to ease pain and brought my blood pressure back to normal. I was released 4 hours later with no diagnosis for what caused the pain, the hospital told me to take Tylenol for pain as needed. When asked what caused it, they said that they didn't know. When I asked if it could have been the vaccine, they said they didn't know.
63 2021-03-01 chest pain, chest discomfort Sharp deep pain in the center of chest, feeling of constriction around chest; pain and tingling in b... Read more
Sharp deep pain in the center of chest, feeling of constriction around chest; pain and tingling in both feet
63 2021-03-02 chest discomfort COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot ... Read more
COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot nausea Day four of shot back and joint pain Day five of shot sick feeling aching all over. Muscle and joint pain and fatigue. Chest pressure, cough, Hoarse voice Day six of shot headache fatigue pain through right eye. 2/5Temp 96.6, 98.6, 1:00pm SPO% 93% Resting heart rate 90 6:30pm SPO% 89%-91% Resting heart rate 102 Tylenol 100 mg 9:00am, 3:30pm TEMP 4:30pm 99.7* Symptoms of the freezing chest and cough as well as headache and feeling poorly kept rising several times a week. Covid 3/1/21 Covid symptoms return just like after Covid 19 1st vaccine. Body aches, joint pain, Chest pain, muscle aches, frozen feeling in lungs, cough, abdominal pain,eye ache, headache and fever. Temp 95.5 SPO 89% - 94% Resting heart rate 92 - 95 (After Covid shot 89%SPO, RHR 105, temp 99.7) 12:25pm temp 99 2/2/21 Feeling a little better. Still fatigue and ill feelings. At nighttime cough comes back with freezing lung feeling. Also started and body aches and joint stiffness. Went to bed took ibuprofen. 2/3/21 Still feeling ill . Woke with productive cough a little looser. Headache fatigue just feeling crummy.
63 2021-03-03 hypertension, chest pain Chest pain radiating to back with associated nausea, transient hypertension
63 2021-03-03 fainting, lightheadedness Patient with no history of fainting after receiving vaccines reported feeling faint 15 minutes after... Read more
Patient with no history of fainting after receiving vaccines reported feeling faint 15 minutes after receiving first COVID vaccine. When patient was unable to clearly answer the pharmacist, 911 was called. Patient was assessed by EMS and it was determined patient experienced a vagal response. Patient remained in pharmacy until she felt better, approximately 1 hour after the side effect initially occurred.
63 2021-03-05 heart rate irregular, blood pressure increased, palpitations fast heart beat (102), raised blood pressure (175/105) 6:00 pm to 12:00 am. Stayed in emergency ro... Read more
fast heart beat (102), raised blood pressure (175/105) 6:00 pm to 12:00 am. Stayed in emergency room for observation till numbers decreased. Palpitations as diagnosis. Released aprox 12:30 am.
63 2021-03-06 chest discomfort Pressure in chest, trouble breathing, facial flushing
63 2021-03-07 heart rate increased Increased heart rate; Feeling very dehydrated; This is a spontaneous report from a contactable nurse... Read more
Increased heart rate; Feeling very dehydrated; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization and lisinopril, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for hypertension. Medical history included patient was prediabetic. The patient's concomitant medications were not reported. On an unspecified date in 2021, patient was having a little bit of concern, she just had side effects that were a little scary. She have had like an increased heart rate and now, feeling very dehydrated. The action taken in response to the events for lisinopril was unknown. The outcome of the events was unknown. Information on the lot/batch number has been requested.
63 2021-03-07 palpitations intermittent palpitaitons
63 2021-03-08 body temperature decreased Diarrhea for 4 hours Chills and Low Body Temperature (below 96 degrees) for 4 Hours
63 2021-03-08 cerebrovascular accident Patient reports having slurred speech beginning 2000 the evening following vaccination. She presente... Read more
Patient reports having slurred speech beginning 2000 the evening following vaccination. She presented to the ER on 02/11/2021 and admitted to hospital for Acute CVA. Discharged on 02/14/2021. Patient's PCP recommended completion of series.
63 2021-03-09 fast heart rate Tachycardia (HR 100 on arrival, was higher at home), numbness/tingling of lips and mouth, ? mouth sw... Read more
Tachycardia (HR 100 on arrival, was higher at home), numbness/tingling of lips and mouth, ? mouth swelling started at 5pm on day of vaccine. Took Benadryl 50mg PO prior to arriving at ED. Felt improved compared to home. Was given Ativan in ED X 2 doses and Benadryl 25mg IV 3 hours after arrival for complaints of eye swelling and itching. Symptoms resolved.
63 2021-03-10 chest discomfort (Note; after 1st dose on February 1st had some tongue and lip tingling within 30 minutes, took Bena... Read more
(Note; after 1st dose on February 1st had some tongue and lip tingling within 30 minutes, took Benadryl 25 mg with relief). Prior to second dose, took Benadryl 25 mg at 310pm.... at 350pm, received second dose of Pfizer vaccine.... tingling of lips and tongue within 10 minutes, took Benadryl 25 mg at 4pm...?. progression of tingling of tongue to some numbness of tongue, towards back of throat, some difficulty swallowing, throat hoarseness, chest discomfort, sporatic spot itching of eyeballs - shoulder-forehead-top of right arm. Went to Emergency room around 5pm.... given corticosteroid and Pepcid IV... with relief. Left Emergency room around 730 with minimal tingling of tongue....no other symptoms. Took Benadryl 25 mg by mouth before bed. 3/6/21- woke up with no symptoms.
63 2021-03-10 palpitations HA and muscle pain at injection site within 1 hour, joint pain at shoulders/hips/ feet starting at... Read more
HA and muscle pain at injection site within 1 hour, joint pain at shoulders/hips/ feet starting at 14 hours post dose and lasting for 36 hours. all treated with tylenol and NSAID. Moderate fatigue requiring rest for 24 hours. palpitations for 30 minutes at 14 hours post dose - no treatment, self-resolved
63 2021-03-10 heart rate increased Jittery, elevated HR, cleared by EMS
63 2021-03-10 chest pain Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced c... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced chest pain radiating down left arm, shortness of breath, and nausea. Patient also endorses numbness to left upper arm and left lower leg. Denies any wheezing, throat swelling, facial swelling, diarrhea, urticaria. Vitals: BP 104/65, Pulse 78, SpO2. On chart review, she had similar symptoms in the past with full stroke workup that was ultimately determined to be conversion disorder. Admitted for observation to rule out ACS. EKG and serial troponin unremarkable.
63 2021-03-10 palpitations patient reported feeling heart racing. Patient did experience heart rate above 100 with elevated B... Read more
patient reported feeling heart racing. Patient did experience heart rate above 100 with elevated BP of 155/91. Patient was observed Additional 15 minutes until BP and HR was stable (BP 132/80 and HR 85).
63 2021-03-10 chest discomfort pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness... Read more
pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness under eyes, checks, and inside her mouth. She had some pinching feelings in her chest which she said this may be acid reflux. Her right leg was hurting near her ankle and foot. Nurse at vax site checked her stats and everything was normal. She was given Benadryl. These symptoms subsided. After getting home she had some tickling in her throat. Pt only has soreness and redness in her left arm today.
63 2021-03-10 heart attack, pulmonary embolism pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; S... Read more
pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown. Information on lot and batch number has been requested.
63 2021-03-11 chest discomfort All over body aches and soreness, headache, heaviness in lungs with shortness of breaths, cough, an... Read more
All over body aches and soreness, headache, heaviness in lungs with shortness of breaths, cough, and hypersensitivity on skin. Took tylenol and rested. Lasted about 4 days.
63 2021-03-11 blood pressure increased Immediate pain from injected arm, across back up the neck, causing headache and going across to ot... Read more
Immediate pain from injected arm, across back up the neck, causing headache and going across to other arm, down arm and making left hand tingle. Sensitivity to use of finger on left hand. That went away next day. Residual effects pain in my jaw and teeth sensitivity, continues to date. Hot flashes, shooting pains in foot, arm, hand, eye, leg randomly. raised blood pressure.
63 2021-03-11 palpitations, fast heart rate extreme dizziness, nausea and vomiting for 9 hours fast heartbeat, palpitations for 9 hours overlapp... Read more
extreme dizziness, nausea and vomiting for 9 hours fast heartbeat, palpitations for 9 hours overlapping headache
63 2021-03-12 heart rate increased Instant headache, fast heartbeat, instant face and headache flush, instant joint pain and very sever... Read more
Instant headache, fast heartbeat, instant face and headache flush, instant joint pain and very severe dizziness and lightheaded.
63 2021-03-12 chest discomfort On 01/09/2021 & 01/10/2021 I was feeling itchy on both sides of my neck. On 01/11/2021 I was feeling... Read more
On 01/09/2021 & 01/10/2021 I was feeling itchy on both sides of my neck. On 01/11/2021 I was feeling heat in the breast area. I saw OB/GYN and was prescribed an antifungal cream. On 01/15/2021 the rash had spread to the abdomen, lower back, on the sides of my abdomen, upper thigh and a few on my forarms, so I had a virtual visit and was told to take benedryl and over the counter cream. It took about 2 1/2 weeks to clear up.
63 2021-03-12 palpitations While waiting in the lot, patient stated she experienced sensation of heart racing, slight SOB, mil... Read more
While waiting in the lot, patient stated she experienced sensation of heart racing, slight SOB, mild anxiety. Monitor called RNS and NP. Patient reported to them that s/s were resolving. Vital Signs were monitored. B/P 100/78, HR 72. RN stayed with patient for 20 minutes. Patient ambulated steadily. Denied further s/s. Left lot at approximately 1300. B/P 108/70, HR 72 Respirations 18. Instructed to continue to monitor and to seek medical attention if symptoms return. RN called patient ! 1435. Patient reported no further s/s. Also mentioned that sehhad hypothyroidism and that synthroid dose had been decreased within that past week.
63 2021-03-13 chest pain After 1 1/2 could not stay awake till sunday. Body aches. Chest pain. Headache.
63 2021-03-14 fast heart rate, chest discomfort Tachychardia, chest pressure, belching, hard to take a full breath
63 2021-03-16 chest discomfort Dizzy, headache. Left chest pressure. Said she has an appointment with cardiologist this week. She w... Read more
Dizzy, headache. Left chest pressure. Said she has an appointment with cardiologist this week. She was seen in Emergency room last week with same complaint and was told it was bone or muscle, not heart. All symptoms resolved when she left.
63 2021-03-16 palpitations Had heart palpations last night , today feel like heart is acing , will call the Dr,
63 2021-03-16 chest pain I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hi... Read more
I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hit" by a very intense reaction: metallic taste in mouth, nauseous, burning heat throughout my back, sweating, very hot, very anxious/scared. This quieted down after about 10 minutes, but then I got "hit" again, a few minutes after that. This time with burning heat in my chest and then burning heat traveling down my left arm, sweating, very hot, very anxious/scared. I was under observation for 45minutes before they let me drive home (just 4 miles away). Once I got home, I felt extremely exhausted and foggy headed. This lasted for about 6 hours, and then it began to lift. That night, I was woken from sleep suddenly by pain in my arm (at injection site); it was a sort of pain I've never experienced -- it was sharp and moving around. The following day (today) I'm having lingering fatigue, lingering slight nausea, and a sore arm at injection site.
63 2021-03-16 palpitations patient is a 63 y/o F who had her Covid 19 Pfizer vaccine 1st dose on 3/10/2021 and began feeing bad... Read more
patient is a 63 y/o F who had her Covid 19 Pfizer vaccine 1st dose on 3/10/2021 and began feeing bad that evening , had 1 emesis episode and felt "crummy" with fatigue/weakness/sweats/malaise for 3 subsequent days without recorded fever, rash , change in color of urine but decreased oral intake and began to feel better 3/14 Sun, she then awoke with Heart racing and presented to our ER 0300 3/15 with A fib with RVR which resolved after approx 30 min while receiving IV fluids in ER without other treatment. She was treated and released to followup here today 3/17/21 at our office. I noticed on routine ER labs that she had elevated transaminases (ALT/AST) in 300 unit range (normal up to 40-50) which she has never had on previous panels with normal bili, alk phos , and otherwise normal CMP. At the time of followup her EKG was normal and she has had no further symptoms but transaminases are redrawn and she is advised not to get her second Covid shot. Patient is elderly CHADS VASC score is 1, nonsmoker , family hx of heart disease.
63 2021-03-17 deep vein blood clot, pulmonary embolism Developed extensive DVT with pulmonary emboli 4 days after receiving Covid vaccine. Clot was evacuat... Read more
Developed extensive DVT with pulmonary emboli 4 days after receiving Covid vaccine. Clot was evacuated with thrombectmy but reaccumulated 1 day later, despite being treated with Eliquis.
63 2021-03-18 blood pressure decreased Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous ... Read more
Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm at 63-year-old (not pregnant at the time of vaccination) on 03Mar2021 at 16:00 (lot number: EN6198, expiration date unknown) at single dose for COVID-19 immunization. Medical history included diverticulitis. No known allergies were reported. The patient was not diagnosed with COVID prior vaccination. Concomitant medications were reported as unspecified other medications in two weeks. No other vaccine in four weeks. On 04Mar2021 at 06:00 AM the patient experienced chills stomach pain joints vomit weak blood pressure (as reported). The events resulted in hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 04Mar2021. No COVID tested post vaccination. It was unknown whether treatment was received. The outcome of the events was not recovered.
63 2021-03-18 chest discomfort, palpitations Noted after about 15 minutes, felt "heart racing" and some shortness of breath. BP 148/98; pulse 80;... Read more
Noted after about 15 minutes, felt "heart racing" and some shortness of breath. BP 148/98; pulse 80; p ox 98%. Monitored and gave water; able to swallow fine. Noted 5-10 minutes later, some "heaviness" in chest--between throat and upper 1/2 of sternum. Vital signs remained the same; husband with her. Continued monitoring; still with heaviness 10 minutes later--slightly less. Called Rapid Response team, heaviness improved; heart no longer feeling of racing. Patient refused ED monitoring, stayed another 10 minutes and felt comfortable leaving. Knows to follow up with provider; seek medical attention if symptoms worsen.
63 2021-03-18 loss of consciousness, lightheadedness Patient received the COVID 19 vaccine (Pfizer) at 1700. She became anxious. Nurses lied her down on ... Read more
Patient received the COVID 19 vaccine (Pfizer) at 1700. She became anxious. Nurses lied her down on a cot where she had a vasovagal response with loss of consciousness. Pt was disoriented x 2minutes. VS: BP 124/80, HR 86, O2 sat 100% room air, RR 18. Paramedics were called to evaluate patient. She was medically cleared by paramedics. Pt had a friend drive her home. Pt was stable when leaving.
63 2021-03-18 deep vein blood clot Pt developed a new onset, acute deep vein thrombosis approximately 6-7 days after vaccination in the... Read more
Pt developed a new onset, acute deep vein thrombosis approximately 6-7 days after vaccination in the R lower extremity with extreme pain and inability to bear weight.
63 2021-03-18 blood glucose increased, hypertension Pt started having new onset of left hand swelling of medial pal, and forearm. PT also had weakness, ... Read more
Pt started having new onset of left hand swelling of medial pal, and forearm. PT also had weakness, tremors and high blood pressure (159/98). Pt blood sugar was in the 330s; decrease cap refill. Pt states she did not ear or drink much this morning. EMS assist was called. Pt was transferred to Emergency Room
63 2021-03-18 platelet count decreased Severe low platelets. Dropped to 8,000.
63 2021-03-18 heart rate increased She received the vaccine, and within 4 minutes she got a tingling feeling that swept through her who... Read more
She received the vaccine, and within 4 minutes she got a tingling feeling that swept through her whole body from her head to her toes. They called a doctor to stand by her, and spoke with her, and she was explaining what she had with reactions had a very warm sensation through her body. They have a medic station at the event center, and started taking her VS which her BP was high, and kept an eye on her, and kept talking to her. She still had the tingling feeling through her. She had this similar sensation from bee stings in the past. She then got very cold and started shaking all over and her went to 175/101. At that point she had probably been there for about 2 hours and she was then taken to Hospital. She was monitored at the hospital for her BP and did oxygen levels which were fine, and her heart rate was elevated, but then dropped down to 98-99. She asked for something to drink and something to eat, and they gave that to her, and was only at the hospital for about an hour. They told her that she was okay, and they did not give her any medications as the reaction had passed and her BP was down to 149/87, pulse rate 102, and her respiratory rate was good and they dismissed her. She did have fatigue since coming home from the hospital but is otherwise okay. She is scheduled to see her PCP on Monday, 3/22/21.
63 2021-03-18 nosebleed Sore arm- first vaccine 12/23/20 and after 2nd vaccine- initially sore arm, fever, chills, sinus sym... Read more
Sore arm- first vaccine 12/23/20 and after 2nd vaccine- initially sore arm, fever, chills, sinus symptoms, headaches- continue to have sinus symptoms- "congestion, headaches, nasal drainage daily with bleeding" Not sure if related to the Pfizer vaccine- just have had continuation of sinus symptoms post 2nd vaccine. Nasal bleeding miner however, frequently throughout day when blowing nose- have been using OTC saline gel or spray-
63 2021-03-18 chest discomfort joint pain, chills, nausea, dizziness, HA, chest is heavy, diarrhea X1 episode, spoke to doctor who ... Read more
joint pain, chills, nausea, dizziness, HA, chest is heavy, diarrhea X1 episode, spoke to doctor who stated the symptoms are "normal", clarified if she mentioned the dizziness & heaviness to chest, reported she did and her pcp stated it was again "normal". informed her those reported symptoms should be checked in the ED for potential cardiac events. Caller verbalized understanding.
63 2021-03-19 chest discomfort APPROXIMATELY 20 MINUTES AFTER THE PATIENT RECEIVED THE VACCINE SHE DEVELOPED DYSPNEA, SUBJECTIVE DI... Read more
APPROXIMATELY 20 MINUTES AFTER THE PATIENT RECEIVED THE VACCINE SHE DEVELOPED DYSPNEA, SUBJECTIVE DIFFICULTY SWALLOWING AND MENTIONED TONGUE SWELLING/PARESTHESIA OF THE LIPS. SHE WAS RAPIDLY ATTENDED TO; AN EPIPEN WAS ADMINISTERED IN LEFT THIGH AND SYMPTOMS PERSISTED. EMS WAS CALLED AT 5:20PM. VITAL SIGNS WERE MONITORED AND RECORDED. SHE LATER REPORTED CHEST PRESSURE; EMS ARRIVED AND SHE WAS TAKEN TO THE HOSPITAL.
63 2021-03-19 fainting syncope
63 2021-03-20 chest pain Burning in chest and throat
63 2021-03-21 hypertension, chest discomfort 20 MINUTES AFTER THE SHOT I EXPERIENCED REDDENING OF THE FACE AND NECK. A FLUSHED FEELING ALL OVER ... Read more
20 MINUTES AFTER THE SHOT I EXPERIENCED REDDENING OF THE FACE AND NECK. A FLUSHED FEELING ALL OVER AND TIGHTING OF MY CHEST. I TOOK ORAL BENEDRYL 10 MINUTES AFTER THE SHOT BUT UNFORTUNETLY IT DID NOT HELP. I WAS GIVE IV BENEDRYL IMMEDIATELY AFTER THAT AND WAS MONITORED FOR 4 HOURS AT THE HOSPITAL. ALSO GIVEN TYLENOL FOR A HEADHACHE DURING MY HSPTALIZATION. IT TOOK APPROX. 30 MINUTES FOR THE SYMPTOMS TO SUBSIDE. I WAS RELEASED 4 HOURS LATER.
63 2021-03-21 heart rate increased Fast heart rate twice approximately 2 hours after vaccine. Once more in late evening after going to ... Read more
Fast heart rate twice approximately 2 hours after vaccine. Once more in late evening after going to bed. Each instance only lasted less than one minute.
63 2021-03-21 palpitations racing heart.. dizziness.. felt like she was going to pass out said tongue was swelling and hard to ... Read more
racing heart.. dizziness.. felt like she was going to pass out said tongue was swelling and hard to breath
63 2021-03-22 hypertension Pain at injection site (84.1%) no ? Fatigue (62.9%) yes ? Headache (55.1%) yes ? Muscle pain (38.3%)... Read more
Pain at injection site (84.1%) no ? Fatigue (62.9%) yes ? Headache (55.1%) yes ? Muscle pain (38.3%) some lower back ? Chills (31.9%) no ? Joint pain (23.6%) neck ? Fever (14.2%) no ? Injection site swelling (10.5%) no ? Injection site redness (9.5%) no ? Nausea (1.1%) no ? Malaise (0.5%) yes ? Lymphadenopathy (0.3%) no Blood pressure high on 4th day with accompanying eye pressure. 155/102
63 2021-03-23 palpitations Pt. stated she felt burning sensation in her left arm, one minute after she got vaccinated, and then... Read more
Pt. stated she felt burning sensation in her left arm, one minute after she got vaccinated, and then she started feeling palpitations. Vital signs taken. BP 99/56, HR 68, O2 Sat 95%, R 18. At 2:21 pm pt. stated she is feeling better and refused to go to the hospital. At 2:43 pm pt. stated she is OK and wants to go home.
63 2021-03-23 heart rate increased, heart flutter Rapid or fluttery heart beat beginning 1 day after vaccine. Randomly throughout day. Somewhat milder... Read more
Rapid or fluttery heart beat beginning 1 day after vaccine. Randomly throughout day. Somewhat milder yesterday and today. Vaccine was Pfizer-BioNTech COVID-19 Vaccine EUE
63 2021-03-23 chest pain at 2 1/2 weeks after first injection had severe asthma attack that caused right posterior chest pain... Read more
at 2 1/2 weeks after first injection had severe asthma attack that caused right posterior chest pain, fatigue, chills- increased use of albuterol with nebulizer 3 times per day
63 2021-03-23 atrial fibrillation began A-Fib as I was most the way home. It remained for more than 30 minutes, but seems to have subs... Read more
began A-Fib as I was most the way home. It remained for more than 30 minutes, but seems to have subsided at this time of typing.
63 2021-03-24 heart rate increased, palpitations, pallor, hypotension Pale and shaky; Pale and shaky; Blood pressure bottomed out; Heart was racing, her heart was beating... Read more
Pale and shaky; Pale and shaky; Blood pressure bottomed out; Heart was racing, her heart was beating really hard/pounding chest; Weakness; Fast heartbeat/Pounding chest; Lightheadedness; Insomnia; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 10Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient reported). A 63-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 at unspecified route in left arm on 08Mar2021 11:30 as a single dose (at the age of 63 years) at for COVID-19 immunisation. Medical history included iodine allergy from an unknown date and unknown if ongoing severe allergy , drug hypersensitivity from an unknown date and unknown if ongoing severe allergy , dysphagia from an unknown date and unknown if ongoing , ongoing Sjogren's syndrome diagnosed 33 years ago , ongoing systemic lupus erythematosus diagnosed 3 years ago , ongoing headache , ongoing intervertebral disc degeneration diagnosed with this about 15 years ago , ongoing fibromyalgia diagnosed 10 years ago , Meniere's disease from an unknown date and unknown if ongoing , supplementation therapy from an unknown date and unknown if ongoing Vitamin c (Verbatim): recommended by dentist bone health and teeth. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for supplementation therapy from 2020 and ongoing; vitamin d3 (VITAMIN D3) taken for hypovitaminosis from 2019 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for hypovitaminosis from Apr2020 and ongoing; timolol (TIMOLOL) taken for glaucoma from 2011 and ongoing; alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for dyspepsia from an unspecified start date and ongoing; cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) taken for fibromyalgia from an unspecified start date and ongoing; cetirizine hydrochloride (GENERIC ZYRTEC) taken for hypersensitivity from 2011 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; olanzapine (OLANZAPINE) taken for bipolar disorder from an unspecified start date and ongoing; docusate sodium (COLACE) taken for constipation from an unspecified start date and ongoing; lactulose (GENERLAC) taken for constipation from 2018 and ongoing; acetaminophen (TYLENOL GENERIC) taken for headache, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; tramadol (TRAMADOL) taken for intervertebral disc degeneration, headache from Dec2020 and ongoing; triamcinolone diacetate (TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]) taken for rash from 2018 and ongoing; meclizine hydrochloride (MECLIZINE HYDROCHLORIDE) taken for dizziness, start and stop date were not reported. The patient experienced heart was racing, her heart was beating really hard/pounding chest on 08Mar2021 with outcome of recovered , pale and shaky on 09Mar2021 with outcome of recovered weakness on 08Mar2021 with outcome of recovered , fast heartbeat/pounding chest on 08Mar2021 with outcome of recovered , lightheadedness on 08Mar2021 with outcome of recovered , insomnia on 08Mar2021 with outcome of unknown , blood pressure bottomed out on 09Mar2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 'bottomed out' on unspecified date 09Mar2021, heart rate: 95, heart rate: 98-101, heart rate: fast. Therapeutic measures were taken as a result of , insomnia. No vaccines administered on same date with the Pfizer vaccine. No vaccinations within four weeks prior to the first administration date. No ER visit or physician office visit reported.
63 2021-03-24 loss of consciousness, platelet count decreased Pt presented today for 1st Pfizer mRNA COVID vaccine. She received the vaccine at 11:06am and proce... Read more
Pt presented today for 1st Pfizer mRNA COVID vaccine. She received the vaccine at 11:06am and proceeded to the check out area and scheduled her second appointment and checked out at 11:10am. She was sitting in the secondary seating area, she looked scared, then she indicated to the APP she felt dizzy, eyes fluttered back, and slumped back into the chair and into APP's arms. With the assistance of another RN, we laid her down on the ground and lifted her legs. She was arousable to sternal rub and complained of dizziness. She was able to report her name and that her husband was outside in the car waiting for her, however, she was slow to answer questions and still appeared distressed. We made several attempts to obtain a BP, however, it would not register on machine, O2 sat 100%, HR 42, manual HR 50 at pericordium. Her bilateral upper extremities were cool to touch and appeared mottled. We attempted to give her apple juice just she was only able to take a few sips. We placed her on 100% non-rebreather. Given low HR, unable to obtain BP, and semi-conscious state, we elected to call 911 at 11:30am. Her husband was retrieved and at patient side when EMS responded. He reported that she has fainted in the past with blood draws and has a past medical history of "leaky valve, low platelets" and later it discovered via her medical records that she has a history of seizures and was on vimpat and lisinoril. EMS arrived, assessed the patient, and moved her to stretcher and transported patient at 11:39am.
63 2021-03-24 low blood oxigenation She had the vaccine on 01/07/2021 afternoon. Then morning of 01/08/2021, she had acute onset of hyp... Read more
She had the vaccine on 01/07/2021 afternoon. Then morning of 01/08/2021, she had acute onset of hypoxia/dyspnea. This lasted for several hours requiring supplimental oxygen and clinical monitoring. It subsided without other intervention.
63 2021-03-24 chest discomfort Tightening in left pectoral muscle in the left arm pit which spread across my chest to the right pec... Read more
Tightening in left pectoral muscle in the left arm pit which spread across my chest to the right pectoral within 15 minutes the tightness moved up into my neck. Within one hour it was gone. It was tightness not pain. Doctor at vaccine site recommended transporting me to the ER. Tests were administered, I was released with follow up recommendations. Next day some intermittent chest tightness-agreeing of pressure from both sides and weight on breast bone. One time tightness in left chest during short walk.
63 2021-03-24 chest discomfort Within 2 hrs of Pfizer covid injection I developed chest tightness with difficulty taking a full bre... Read more
Within 2 hrs of Pfizer covid injection I developed chest tightness with difficulty taking a full breath. Significant substernal chest pain radiating to between shoulder blades. Sent to ER around 6:30 pm. Cardiac ez troponin negative, CBC, BMP normal, 2 12 lead EKGs normal, CXR normal. BP and HR slightly elevated but stable. Acetaminophen 650 mg po given. ER physician dx vaccine adverse effect.
63 2021-03-25 loss of consciousness 10 min after: shot rush of blood back to site of injection, 11min after: wanting to cough, next mor... Read more
10 min after: shot rush of blood back to site of injection, 11min after: wanting to cough, next morning: passing out on bathroom floor
63 2021-03-25 heart rate increased Five min. after injection: Pulse raced for short period of time (15 sec), during that time felt pre... Read more
Five min. after injection: Pulse raced for short period of time (15 sec), during that time felt pressure in left wrist, later that day experienced large bruise on the on the left wrist,
63 2021-03-25 fainting, blood pressure decreased I had a vaso-vagal syncope and a very severe drop in Blood pressure.
63 2021-03-25 blood pressure increased patient become diaphoretic and felt like she was going to pass out. pt wheelchaired to bed bp 100/64... Read more
patient become diaphoretic and felt like she was going to pass out. pt wheelchaired to bed bp 100/64. pt never lost consciousness. bp came up to 126/74. pt called husband to come in and drank 2 apple juices. EMS requested at 1615. patient then stated she felt woozy and became diaphoretic again. repeat bp 85/56. it later increased to 109/68, sat 97, hr 82. pt also incontinent
63 2021-03-26 chest discomfort Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest... Read more
Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest, no care attitude, muscle pain, headache, nausea- emptiness in stomach, possibly swollen lymph nodes. This continued until 6pm the next day (3/25/2021) after receiving the covid vaccine. Should I get the 2nd vaccine, scheduled for 4/15?
63 2021-03-26 hypertension Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness... Read more
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Swelling of the injection site, jaw spasm, high blood pressure-Mild, Systemic: Hypertension-Mild, Additional Details: Patient started to have swelled injection site arm after about 30 minutes of vaccination but patient remained responsive. 11:40pm - BP 198/100, HR 72. 12pm- BP 198/100, HR 72 & complained of dystonia symptoms so we called 911 paramedics came within 5 minutes. 12:15pm- BP 240/110, HR 72. Called patient's daughter at 2:01pm (patient still in the ER), at 3:16pm (left message to voice mail). Patient did not mention she has history of dystonia after getting any vaccine when asked prior to vaccination
63 2021-03-27 palpitations, fast heart rate severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss i... Read more
severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss intermittent left eye for 5 minutes at a time ( 5 events over one month), continued to this day intermittent diplopia vertical , with blurring vision and eye fatigue , general fatigue with ADL ( missed multiple days of work), bouts of tachycardia and palpitations ( slowly abating over 6 weeks ) , original neck pain and headache severe in first 2-3 weeks especially after second vaccine 1/29/21 lot number EL3246. multiple MRI's done brain ( white matter and demylination dating back to before 2015) and cervical and thoracic spine showing existing disc disease all old , neurology work up was done for MS and it was ruled out. visual disturbances persist and neuro-ophthomologist appointment schedule for mid april .
63 2021-03-28 chest discomfort Mild tightness in chest, coldness in fingers bilaterally. No SOB. No numbness and tingling in hands ... Read more
Mild tightness in chest, coldness in fingers bilaterally. No SOB. No numbness and tingling in hands Vital Signs: B/P: 140/88 HR:63 Resp.: 20 O2Sat:99 Skin Signs: Warm and Dry Circulation: Cap Refill <2Sec Resp.: Breath Sounds Clear Bilaterally Treatment: 11:40 symptoms subsiding, improvement noted. Reassessment @11:45 Vitals: 132/84 HR:60 Resp.: 20 O2Sat: 99 Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath sounds clear bilaterally Treatment: Advised patient to call 911 if symptoms return or notify PCP. Symptoms resolved at 11:45, encouraged to monitor symptoms, encourage hydration throughout the day. D/C home by self
63 2021-03-30 palpitations feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, n... Read more
feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related.; feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related.; heart rate started pounding; lightheaded and dizzy feeling; shaking all over; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration, administered in arm left on 02Mar2021 12:45 as a single dose (at the age of 63-years-old) for covid-19 immunisation. Medical history included high blood pressure that was treated with metoprolol from an unknown date. The patient had known allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medications included metoprolol succinate taken for high blood pressure, start and stop date were not reported; escitalopram taken for an unspecified indication, start and stop date were not reported. The patient previously took prednisone and ciprofloxacin and experienced drug allergy. At about 25 minutes after receiving the vaccine (02Mar2021 13:15 as reported), the patient had a feeling of extreme warmth or heat in the center of her chest (about where her sternum was). It was a sudden feeling that started radiating outward, seemingly along her arteries and at the same time, her heart rate started pounding, accompanied by a lightheaded and dizzy feeling. The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related. It wasn't a panic attack either. The patient started shaking all over while was driving up and immediately looked for a place to pull over, and began texting someone close by (her brother) to let him know what was happening. No treatment was received for the reported events. The reported events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.
63 2021-03-31 loss of consciousness passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pai... Read more
passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pain; temperature of 99.6; flu-like symptoms; This is a spontaneous report from a contactable Other Health Professional (patient). A 63-year-old non-pregnant female patient received bnt162b2 (Pfizer Brand COVID 19), dose 2 intramuscular, administered in left arm on 26Feb2021 12:00 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination. The patient has no known allergies. Concomitant medication included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer Brand COVID 19), dose 1 intramuscular, administered in left arm on 05Feb2021 11:30 AM, (Lot Number: EM9810) for COVID-19 immunisation. There was no other vaccine in four weeks. On 27Feb2021 07:45, the patient passed out, unfortunately hit head, felt light headed and slightly nauseous. It was also reported that patient had intense right knee pain, a temperature of 99.6 and flu-like symptoms. The events were also described as follows: 18hrs after the injection, I had intense right knee pain that lasted for 24hrs. Also in that same time period, I felt a huge rush of energy come over me and passed out. Unfortunately hit my head. I had a temperature of 99.6 and flu-like symptoms that lasted 24hrs. For 4 days I felt light headed and slightly nauseous but that could have been due to hitting my head. Called 911, EMT evaluation and the patient received treatment for events. Outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events and other events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
63 2021-04-01 hypotension, body temperature decreased, pallor rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso... Read more
rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.
63 2021-04-05 oxygen saturation decreased, very slow heart rate, heart rate decreased Pfizer COVID Vaccine EUA Patient received 1st dose of Pfizer vaccine 3/11/21. 3/27/21: Patient is ... Read more
Pfizer COVID Vaccine EUA Patient received 1st dose of Pfizer vaccine 3/11/21. 3/27/21: Patient is a pleasant 63-year-old female past medical history of anxiety, documented history of hyperlipidemia came in from outside facility with complaints of dyspnea, COVID-19 pneumonia, bradycardia. Clinical picture started on the 17th patient tested positive for COVID-19 at that time was having symptoms myalgia, subjective dyspnea reportedly went to the emergency department, saturations were good she was discharged home with conservative measures. At home became more symptomatic and pulse ox was measuring in the low 80s so she went back to the hospital and was admitted to Hospital on 03/25. Per records patient was started on Eliquis, dexamethasone, azithromycin, remdesivir, p.r.n. Tylenol, p.r.n. Zofran, p.r.n. Toradol along with supplemental oxygen. Oxygen requirement was 5 L at the facility. However overnight and prior to arrival providers at outside facility started noticing bradycardia patient's heart rates were dropping into the 30s. Patient was asymptomatic during these episodes not complaining of any lightheadedness or chest pain. Reportedly cardiologist saw patient QT and QTC were reportedly appropriate recommended monitoring. However overnight heart rate continued to go down into the 30s, reportedly on telemetry was noted to be developing Mobitz 2 second-degree block, patient was administered atropine x2 and heart rates improved to the 70s however a year started going down again to 30s and 40s after a couple of hours. Outside facility requested transfer to another hospital for further management and possible EP intervention. Bedside patient is lying comfortably in bed currently denies any lightheadedness, dizziness, chills, fevers, nausea, vomiting, diarrhea, chest pain, palpitations, paresthesia, swelling of extremities. Though is she gets winded after exertion, is okay/comfortable on supplemental oxygen at rest. Patient was increased to 8 L during ambulance ride, was id saturating however medics increased because of bradycardia. Otherwise denies tobacco, recreational drug/marijuana, over-the-counter/herbal medication use. Social consumption of alcohol will have 1-2 beers a year. She reports sick contact 1 of her close friends was diagnosed with COVID earlier this month, husband also positive. She reports she received 1st dose of COVID-19 vaccination around the 10th or 11th of this month 1 day prior to known exposure. Otherwise no medication changes is only on sertraline. Currently no antihypertensive medication or rate-controlling agents. 4/1: Patient was admitted after developing significant bradycardia after receiving remdesivir for COVID-19 pneumonia. Remdesivir was held and patient received convalescent plasma on 03/28. Dexamethasone was started at the outside hospital on 03/25. With also completed 5 days of empiric doxycycline and Rocephin. Patient CRP and D-dimer were followed and trended down at the time of discharge. EP Cardiology was consulted and initially the patient was on dopamine for the 1st 2 hospital days. Was able to be stopped and the last 2 hospital days the patient had no bradycardia. She will have a Holter monitor as an outpatient. Patient wore her BiPAP at night. Oxygen requirements trended down and was able to be on room air at the time of discharge. Home O2 evaluation was performed and did not require oxygen. She will continue on 5 further days of Decadron 6 mg daily. She will follow-up with her PCP.
63 2021-04-06 cardiac failure congestive Congestive Heart Failure
63 2021-04-08 blood clot, pulmonary embolism Developed blood clots in my lungs. Had a pulmonary embolism performed to dissolve the clots.
63 2021-04-11 deep vein blood clot 12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21. Then on... Read more
12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21. Then on 4-7-21, my left leg calf was very sore and hard for me to walk, Got worse, so on 4-9-21 went into Urgent care and through a vascular ultra sound determined I had a very Large blood clot in my calf. (ACUTE THROMBOSIS OF THE LEFT PROXIMAL PERONEAL VEIN)
63 2021-04-13 deep vein blood clot 2/28/21 Four days after 1st Pfizer vaccine 2/24/21 Severe cramping and swelling in my right leg ... Read more
2/28/21 Four days after 1st Pfizer vaccine 2/24/21 Severe cramping and swelling in my right leg and ankle. 3/9/21 Work clinic advised to seek medical attention 3/9/21 Hospital Emergency Room Diagnosis: Deep Vein Thrombosis (DVT)- Blood Clot 3/10/21 Thrombectomy Surgery & Released 3/11/21 Swelling in right leg and ankle Returned 3/12-16/21 Readmitted - Blood Clot returned Currently under several doctors care.
63 2021-04-13 cerebrovascular accident On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 ... Read more
On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 strokes. I woke up with a throbbing headache and then had difficultly remembering simple things like using the remote control for TV. My vision was also somewhat blurry. I then went to drive and my focus was off making driving difficult so I then went to the emergency room
63 2021-04-14 pulmonary embolism Acute Pulmonary Embolism-Bilateral , Hypertensive Crisis
63 2021-04-14 hypotension, low platelet count Thrombocytopenia AKI (acute kidney injury) Neutropenic fever C. difficile colitis Hypotension, un... Read more
Thrombocytopenia AKI (acute kidney injury) Neutropenic fever C. difficile colitis Hypotension, unspecified hypotension type Sepsis
63 2021-04-15 loss of consciousness Felt dizzy 15 minutes after the shot and dizzy throughout the day on Friday, April 9, 2021 On Saturd... Read more
Felt dizzy 15 minutes after the shot and dizzy throughout the day on Friday, April 9, 2021 On Saturday, April 10, 2021 felt extremely dizzy in morning and passed out in a back room. Fell backwards on the floor and couldn't get up. Was yelling and screaming from the pain. Husband called 911 for an ambulance. I was taken to the Hospital and was admitted to hospital. Was very dizzy. Was not allowed to even get up for 2 days in the hospital because I was considered a serious fall risk. Stayed in hospital until Wed., April 14, 2021 when I was released to go home.
63 2021-04-17 hypertension blood pressure went up over 210/110; This is a spontaneous report from a contactable consumer report... Read more
blood pressure went up over 210/110; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6205/expiration date: not provided), via an unspecified route of administration, on 06Mar2021 at 13:45 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included high blood pressure. The patient had known allergies to sulfa drugs and sulfamethoxazole and trimethoprim (BACTRIM). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included olmesartan medoxomil 20mg, naproxen, and fexofenadine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 at 03:00, the patient experienced blood pressure went up over 210/110. The clinical course was as follows: within 3 days of having the vaccine, her blood pressure went up over 210/110 (as measured by EMT). The patient was on blood pressure medication but have never had a blood pressure reading that high before. One reading during that same day was 247/100 but dropped to 160/90 when she took a second reading. The patient took blood pressure medicine but remained high. The event blood pressure went up over 210/110 was considered serious (medically significant). The event resulted in an Emergency Room visit. Treatment was received for the event blood pressure went up over 210/110, which included additional blood pressure medication and diazepam (VALIUM). The outcome of the event blood pressure went up over 210/110 was recovered on an unspecified date in Mar2021. Since the vaccination, the patient had not been tested for COVID-19.
63 2021-04-17 heart rate irregular, atrial fibrillation has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart ra... Read more
has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart rates; She'll have a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night.; When probing for specific event information she reports it's kind of like she coughs a little more and she is a little more short of breath and it's happening more often; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 63 years, via an unspecified route of administration on 27Mar2021 04:06 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history included asthma, hysterectomy, dark chocolate or red dye (she starts coughing and has an allergic reaction and shortness of breath), bursitis (in her right). The patient's concomitant medications were not reported. The patient previously took penicillin, experienced allergy and had really ad hives (several years ago) she was given a cream to put on. She had to get another medication and she doesn't remember the name. That medication made her dizzy and she couldn't even get out of bed so they had to half the dosage. When she had her hysterectomy she learned she couldn't take any types of "cillins" medications. The patient had been watching her heart rate with a device and since getting the Covid 19 vaccine she's noticed her heartrate was always higher than it normally is. Her heartrate was going crazy, the device was not recording right. She reports that for the last 2 days the device has been telling her she has possible atrial fibrillation. This is worrying her. She doesn't feel anything different. She was usually hyper. Her resting heartrate was higher. Normally her resting heartrate was in the 80s (beats per minute) Now it's going up to the 90s (beats per minute) then her heartrate drops to 40 something (beats per minute) Then the device said her heartrate was 118 and 107 and she's not even doing anything. She hasn't even worked out yet. She doesn't like to take medicine. Medications don't work out with her. She had a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night. It was reported that she feels fine. She has no other symptoms. She's been reporting online. Clarified she's reporting online through the V check through the CDC. She's been trying to get the Covid 19 vaccine forever. She did research on all the Covid vaccines and she felt more confident with the Pfizer Covid 19 vaccine. Her daughter was against the Covid 19 vaccine. Her daughter thinks the vaccine was just going to kill her. She reports she was healthy and she works out 6 days a week. She recently tried to get a CT scan for her heart. Her husband's cardiologist recommended her husband have a CT scan of his heart and she decided she needed a CT scan too. She's also watching her heartrate on her watch. Her husband's heartrate is completely normal and stable on the device so she knows the device isn't messed up. It was also reported that the device will tell her she has too much muscle movement and she's standing completely still. Then she'll get the device to record her heart rhythm and it goes sporadic. The device tells her 90 beats per minute at resting then over 100 beats per minute. Her heartrate on the device was going up and down a lot. When she's been watching the device record her heart, it looks like it's going crazy. Her heartrate goes way up and way down like in the 40s (beats per minute) She noticed when her heartrate is in the 40s (beats per minute) and she's never had her heartrate go down that far, it's really really weird. She thinks maybe she'll get back to normal. She keeps watching hear heartrate. She reports she noticed her heartrate right away on Saturday evening after she received the Covid 19 vaccine. Her heartrate was higher than normal for resting, it was in the 90s (beats per minute). Her resting heartrate is usually in the 60-80s (beats per minute) and it was the in 90s. Now the device says possible atrial fibrillation. It was further reported that she received the Covid 19 vaccine in her left arm because she has bursitis in her right. If she hit her arm the second day after the Covid 19 vaccine, her arm would hurt. Her arm felt better the next day. She clarifies, on Sunday, 28Mar2021, she noticed her arm felt like a bruise and that was it. Then the next day on Monday, 29Mar2021, the feeling was gone. She didn't have any redness. The outcome of the events her arm felt like a bruise and arm would get hurt was recovered on 29Mar2021, irregular heart rates, dyspnea, cough was not recovered and unknown outcome for has possible atrial fibrillation. Information on the lot/batch number has been requested.
63 2021-04-18 heart flutter, heart rate increased Woke up around 3:30 am on 02Apr2021 with a rapid heart rate; rush through her body from feet to head... Read more
Woke up around 3:30 am on 02Apr2021 with a rapid heart rate; rush through her body from feet to head, very rapid heart rate (fluttering); tongue-tingling; This is a spontaneous report received from a contactable nurse (patient) reporting for herself. A 63-year-old female patient received the first dose of BNT162B2 (Lot Number: ER8733), via an unspecified route of administration, administered in right arm on 01Apr2021 08:45 (at the age of 63-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history included exercise-induced asthma, SVT (Supraventricular tachycardia). Concomitant medication included sotalol. The patient previously took ciprofloxacin and diazepam (VALIUM) and had allergies to both. Approximately 5 minutes after receiving vaccine on 01Apr2021 (08:50), the patient experienced a rush through her body from feet to head, very rapid heart rate (fluttering) which lasted approximately 1min, tongue-tingling which lasted approx. 8 hours. Woke up around 3:30 am on 02Apr2021 with a rapid heart rate. She notified her PCP and cardiologist's office that morning. There was no treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event tongue-tingling on 01Apr2021 16:50. The outcome of the event rapid heart rate was not recovered.; Sender's Comments: Based on the information currently available and known vaccine safety profile, the causal association between the event of a rush through her body from feet to head, very rapid heart rate (fluttering) is assessed as unrelated to the usage of the vaccine BNT162B2 and more likely due to the possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
63 2021-04-18 hypertension, oxygen saturation decreased shortness of breath, wheezing, coughing, low oxygen levels, high blood pressure
63 2021-04-20 fast heart rate Also had .34 Troponin level; Atrial Flutter episode; Heart racing at 165 BPM; This is a spontaneous ... Read more
Also had .34 Troponin level; Atrial Flutter episode; Heart racing at 165 BPM; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 19Mar2021 at 16:00 (batch/lot number: EP7534) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included prucalopride succinate (MOTEGRITY) taken for an unspecified indication, start and stop date were not reported. Nine days post vaccine (as reported; pending clarification), the patient had a atrial flutter episode with heart rate at 165 bpm. She went to ER and the atrial flutter was confirmed via EKG. Also had .34 troponin level. She was kept overnight and multiple test were run. She was healthy, active with no other risk factors. The start date of the adverse events were reported as 03Apr2021 (as reported; pending clarification). The adverse events resulted in emergency room/department or urgent care. Treatment was received for the adverse events which included blood thinner, Lipator (as preventative). The events were assessed as serious with the serious criteria of hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, COVID-19 swab taken at ER on 04Apr2021 with negative test result. The outcome of the events was recovered on an unspecified date.
63 2021-04-24 cerebrovascular accident, fainting Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; ... Read more
Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.
63 2021-04-24 hypertension, palpitations some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headach... Read more
some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
63 2021-04-26 fast heart rate tachycardia within 1 week of vaccine #1
63 2021-04-28 cerebrovascular accident Stroke; MRI showed Pontine Stroke; left arm was weak; her writing looked like a baby's scribble/she ... Read more
Stroke; MRI showed Pontine Stroke; left arm was weak; her writing looked like a baby's scribble/she cannot write or type; arm was sore; she sounded different; they said her speech sounded slurred; was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4; was not able to walk at first; her arm was cold; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 24Feb2021 08:00 (at the age of 63-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included high blood pressure that was diagnosed 2-3 years ago, diabetes; she was prediabetic, heart;cholesterol has been high for about 30 years; since she was in her 30s; all from an unknown date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 02Feb2021 (at the age of 63-years-old) for covid-19 immunization. The patient had no prior vaccination in four weeks. Concomitant medications included rosuvastatin taken for blood cholesterol and takes 20mg once a day prior to stroke and in the hospital they increased it to 40mg once a day and ongoing; ramipril taken for blood pressure and she was prescribed with this medication for a while prior to her stroke. It was discontinued in the hospital. Stated that she did not take it everyday because she was allergic to it; and sitagliptin (JANUVIA [SITAGLIPTIN]) taken for diabetes from an unspecified start date and ongoing and stated that she has been taking for quite a while. On 24Feb2021 she had her second shot. She said that everything was fine that morning; that afternoon her arm was sore. Stated she thought nothing of it. That evening she entertained guest. They were saying she sounded different; they said her speech sounded slurred. She had gotten her vaccine at around 08:00. Again, she didn't think anything about her speech. On 25Feb2021, she got up and did some laundry going up and down the steps. Stated that it was difficult because her arm was still sore. She cleaned the house. At around 15:30 she was doing bills and noticed that her writing looked like a baby's scribble. On 26Feb2021, she noticed that her left arm was weak and was told by her doctor to go to the Emergency Room where they told her she had a stroke. She added that it seemed like her arm was cold for a number of weeks. Stated she was the type to wear t-shirts in the winter because she was always hot. During those weeks she was wearing heavy clothes and was under blankets. She was just now starting to feel more like herself and not so cold all the time. The patient was unable to recall time frame when this symptom began. The events did require a visit to emergency room and physician office. The patient was hospitalized for 4 days due to the events from 26Feb2021 to 01Mar2021. During hospitalization, the patient saw a cardiologist, neurologist, her primary care provider, and the hospitalists who all said it was very suspicious that her stroke happened right after her vaccine. Before she got her second vaccine, she was doing embroidery and everything she normally does; nothing was wrong. They did a CAT Scan that showed nothing. Then the MRI of the brain showed a Pontine Stroke on 26Feb2021. Cardiologist put a heart monitor on her and could not find anything. They were looking for A-Fib or something like that when she was on the heart monitor in the hospital; but it never showed anything irregular. She had a loop recorder implanted to monitor her heart and they haven't found anything wrong on it. She had heart tests, carotid artery tests, ultrasound of her heart and nothing was found on those tests. They pretty much told her in the hospital that they couldn't find a reason for her stroke. She kept asking about the vaccine. They did not rule it out as a cause, but they also did not say it was the cause. All the doctors said they could not pin her stroke on the vaccine. They stated it was suspicious and that they had seen 2-3 other patients with a similar situation. One of the doctor's told her he would not rule it out. They did an ultrasound of her carotids and heart and did not find anything on those tests that would have caused her stroke. She was having lasting effects related to her stroke. Her arm was still sore at times, stated it was a different kind of sore and could be related to all the therapy she does now. The lingering effects after stroke was reported as she was not able to walk at first. She's been doing therapy focused on her left side. Stated that her left side was the dominant side and she cannot write or type. She couldn't do the report online due to the difficulty with typing. She wanted to make sure this was reported. The patient has been doing therapy for 7 weeks, twice a day; and stated she likely still has months more of therapy to try and get her left side back to normal. She said that simple daily duties are difficult. The patient also stated that she was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4. She doesn't know what made it go up. Then states she doesn't know if the vaccine made it go up or not. She has a follow up with the neurologist soon. The patient also reported medications she has been taking since her stroke and hospitalization; but not prior to her vaccine which included Amlodipine-Benazepril: 5-20mg once a day and Aspirin: 325mg once a day. The patient stated that stroke and heart problems do not run in her family. The outcome of the events was unknown.
63 2021-04-29 vaginal haemorrhage 4/27/21 started having scant/light vaginal bleeding dark in color that persisted through that day re... Read more
4/27/21 started having scant/light vaginal bleeding dark in color that persisted through that day resolving. Spoke with her liver specialist who ordered CBC, PLT which was interpreted by MD Liver as normal. Follow up with gyn
63 2021-04-30 chest discomfort stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has... Read more
stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has a rash about the size of a quarter at the injection site; temperature of 102 degrees/fever; tightness in her chest; She threw up five times; She felt nauseous; Nightmares; She started coughing; muscle weakness; Her arm is sore; She could barley lift her arms; very very weak; delirious; restless; her head was pounding; has been sleeping an enormous amount.; headache; restless; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm right on 12Apr2021 15:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included Neuropathy, Blood pressure abnormal, and allergic to cats, dogs, and everything outside. Concomitant medications included clonazepam taken for neuropathy peripheral, start and stop date were not reported; captopril taken for blood pressure abnormal, start and stop date were not reported; cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 23Mar2021 15:40 (Lot number: EH6204, She has difficulty reading the handwriting, she stated that the second character H, may not be an H.) (at age of 63-year-old) in right arm for Covid-19 immunisation and she felt like she got hit by mac truck, she was that tired and She felt like she could hardly move. There was no additional vaccines administered on same date of the Pfizer suspect or prior vaccinations (within 4 weeks). On the weeks that she received the first and second dose of her COVID vaccine, she skipped getting her allergy shot that week. She normally got her allergy shots every week. Patient weight: 176-178 pounds. It was reported that the patient was fine after she received the second dose, until about 11:00PM on 12Apr2021. She started to get muscle weakness. She was delirious on Monday night (12Apr2021). She also felt restless on 12Apr2021. Her head was pounding on 12Apr2021. She felt nauseous on 13Apr2021, very very weak began on 12Apr2021 23:00 and had tightness in her chest on 13Apr2021. She has only thrown up three times in 50 years. She threw up five times on Tuesday, 13Apr2021. She started coughing Tuesday morning, 13Apr2021. She thought maybe she was coughing because she needed to throw up. She does not know why she is coughing. Over the past few days, she has stayed in her pajamas so she did not look for a rash. She noticed she has a rash about the size of a quarter at the injection site. She did not really pay the rash much attention since she was so sick. She has a rash about the size of a quarter at the injection site, She noticed it on 14Apr2021 whenever she took a shower and took of the band aid. Clarified that it is about the size of a silver dollar. There was also a knot. She began running a fever on 13Apr2021. Yesterday (14Apr2021), she had a fever of 102 degrees. She has been taking 2,000-3,000mg of Tylenol and it has not been helping her fever. Yesterday (14Apr2021), her temperature was the same, and her head was pounding. She was able to eat a little bit, she drank a lot. She has been sleeping an enormous amount from 12Apr2021. Last night (14Apr2021) her temperature was at 100 degrees. It started to come down, before she got up. She normally does not sleep eight hours a night. She has been sleeping more than eight hours. Before she got up out of bed this morning (15Apr2021), she checked her temperature and it was 98.6 degrees. She knows that most people do not consider that a fever, but for her that is. Her temperature is usually 97 something degrees. 98.6 degrees is still sick to her. She was going to work from home today (15Apr2021), but whenever she sat at the keyboard to type, she could barley lift her arms. She could barley lift her arms began about 11:00PM on 12Apr2021. She has not tried to work. She still has a bit of a headache, and her fever broke, so she thought she could work today (15Apr2021). She felt extremely weak. Her stomach was cramping. She drank some tea, and ate a banana. She would describe it as stomach abdominal cramping. She was not expecting to feel this way. Her arm was still sore. Her arm was sore began about 11:00PM on 12Apr2021. She was going to see her doctor next week for a semi annual check up appointment.She was restless all day yesterday (14Apr2021). She has a back back, and has back pain. Whenever she has muscle weakness, her back is bad, and makes her hurt every where. Yesterday (14Apr2021), she was still restless and could not sit still. It is better today (15Apr2021), but has not gone away. On the morning of 13Apr2021, she felt nauseous. Now she feels a different type of nauseous. Before the nausea was in her chest, she thought she was going to have a heart at-tack. She called her husband at work, and asked him to come home because she was so scared. Whenever she threw up, it relived the pressure in her chest. She vomited four times and it gave her immediate relief. She vomited one more time later that evening after trying to eat some chicken broth. She just drank liquids after that. Nauseous intestinal: It feels more intense today (15Apr2021). It feels like it is moving down. Clarified that this is the same feeling as stomach abdominal cramping. She has issues with IBS, and diver-ticulitis. But this is different. She has not eating anything. With IBS, it is eating and the diarrhea. This is more like gassiness. She has had bowel movements, they are more intense with abdominal con-tractions. Very weak: Began about 11:00PM on 12Apr2021. She knew that night that she was not going to be able to go to work the next day. It is better. She thought that is was resolved this morning (15Apr2021), but then she could not get up the stairs. Her office is upstairs. Whenever she got to her office, she lifted her her arms to type and it was hard for her to hold her arms up. She has been sleeping an enormous amount: She did not do anything but drink, use the bathroom and sleep on 13Apr2021. Whenever she was sleeping, it was not a good sleep. Her temperature was 102 degrees, and her head was pounding. She was having nightmares. She was in a constant state of dreaming that she could not get out of. She still has been sleeping a lot. She has been trying to walk around. She put on a lidocaine patch, and is wearing a back brace. She was sleeping less than she was but it is still an enormous amount for her. She normally sleeps about five to six hours a night. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken. The outcome of events muscle weakness, restless, 'Her head was pounding', Weakness, cough, was recovering, of delirious was recovered on 14Apr2021, of 'tightness in her chest' was recovered on 13Apr2021, of nightmares was recovered on 14Apr2021, of other event was unknown.
63 2021-05-03 loss of consciousness passed out at home; Migraine; chills; aches; tired; slight temp; This is a spontaneous report from a... Read more
passed out at home; Migraine; chills; aches; tired; slight temp; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in right arm on 12Apr2021 (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included High cholesterol, hypothyroidism. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2, at the age of 63-year-old, via an unspecified route of administration, administered in left arm on 20Mar2021 18:30 (Lot Number: ER8727) as single dose for covid-19 immunisation. The patient was not pregnant. The patient experienced migraine, chills, aches, slight temp and tired on 13Apr2021 10:00; passed out at home 22:30 13Apr2021. No treatment received. The outcome of the events was recovered in Apr2021.
63 2021-05-07 deep vein blood clot DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right sh... Read more
DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.
63 2021-05-07 chest discomfort incredibly horrible itching under her Fitbit; whelp; her lips had started swelling; her tongue was t... Read more
incredibly horrible itching under her Fitbit; whelp; her lips had started swelling; her tongue was tingling; she thinks that it was the beginning of anaphylactic reaction; she was just tired; type 1 hypersensitivity; a little soreness; It was like heaviness on her chest; having trouble breathing; allergic contact dermatitis; This is a spontaneous report from a contactable consumer (patient) and a physician. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 10:00 (lot number: EP7533) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing nickel allergy for decades which was under control and panic attacks. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021, it was reported that the patient didn't have any of the normal side effects such as fevers or chills but she was just tired and went to sleep early that night. She woke up on 15Apr2021 at 05:00 with incredibly horrible itching under her Fitbit that she wears to bed. She has a history of nickel allergy and she bought this particular Fitbit on purpose because it doesn't have any nickel in it that touches her skin and she has had no problems all year with the Fitbit. The itching was unbelievably bad and when she took the Fitbit off she had a horrible whelp under a tiny piece of metal that isn't even supposed to touch her skin. She thought well if it has exacerbated her nickel allergy then maybe it is doing something else to her body. On that day (15Apr2021), she thought that she had a panic attack and upon reading some information online, she thinks that it was the beginning of anaphylactic reaction because the symptoms are the same. She was thinking that the vaccine is doing something with her nickel allergy. It had used to be bad until she got it under control and she had it under control for many years. But with the things under the Fitbit she was blaming or associating it with the COVID vaccine so she took it off and then finally fell asleep again. But when she woke up in the morning, just a few hours later (15Apr2021), the bad whelp was still there and then her lips had started swelling and her tongue was tingling so she decided to look some more on google and she thinks that this is another version to an allergic reaction. She has had panic attacks before and she knows what they are now and she has learned through a therapist on how to get past and manage them but this was different for her. It was like heaviness on her chest and it felt like something was on top of her chest and she was having trouble breathing; both on an unspecified date in 2021. Her husband knows when she has a panic attack but this one was different she can't really explain it. She asks, what is the difference between a panic attack breathing and this type of breathing and later mentioned that she also had a little soreness (2021). In addition, the physician also called to report that this patient was complaining about 2 types of symptoms. The first was more an allergic contact dermatitis (2021) which the physician is not worried about. The second was lip swelling and tongue tingling which could be a type 1 hypersensitivity (2021). The physician is more concerned about the latter and would like to know if it is okay to pre-medicate the patient with Benadryl before getting the second dose. The outcome of the event 'she was just tired' was recovered on 14Apr2021; incredibly horrible itching under her Fitbit; whelp was recovering; her lips had started swelling and her tongue was tingling was recovered on 15Apr2021. The outcome of the other events was unknown.
63 2021-05-10 low platelet count Hypo-osmolality and hyponatremia Thrombocytopenia, unspecified
63 2021-05-10 nosebleed had the worst nose bleed she ever had; had the worst nose bleed she ever had/gets nose bleeds but us... Read more
had the worst nose bleed she ever had; had the worst nose bleed she ever had/gets nose bleeds but usually lasts for 5-10 minutes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 24Apr2021 13:15 (Batch/Lot Number: EW0176) 2nd dose single for covid-19 immunisation. The patient medical history includes nose bleeds (patient states she is susceptible to nose bleeds). There were no concomitant medications. The patient previously received first dose of BNT162B2 for Covid-19 immunization on unspecified date and Shingles shot for immunization on unspecified date. The patient experienced had the worst nose bleed she ever had on 24Apr2021 22:30. It lasted until a little after 03:00 AM on the 25Apr2021, noting it took five hours to stop. The patient reported that she gets nose bleeds but usually lasts for 5-10 minutes. The patient added she was going to go to the ER if it had not stopped. The patient also reported that she gets nose bleeds but they usually stop in ten minutes. Patient was not sure if this was a side effect or a coincidence. The patient was not sure that this has anything to do with the COVID shot. The outcome of the events recovered on 25Apr2021.
63 2021-05-11 nosebleed, platelet count decreased Platelet count of 4, bleeding (nose, urine. stool), petechiae & bruising over body. Patient given p... Read more
Platelet count of 4, bleeding (nose, urine. stool), petechiae & bruising over body. Patient given platelet transfusion, high dose dexamethasone and IVIG. Platelet count rose to 29. Discharged and follow-up with hematology
63 2021-05-12 atrial fibrillation, hypertension 3-4 weeks after the 2nd dose experienced intermittent atrial fibrillation for over 3 weeks, then de... Read more
3-4 weeks after the 2nd dose experienced intermittent atrial fibrillation for over 3 weeks, then developed hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure; hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure; This is a spontaneous report received from a contactable nurse (patient). A 63-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 01Mar2021 15:00 (Batch/Lot Number: EN6200) as 2ND DOSE, SINGLE for covid-19 immunisation. No pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included Hypothyroid. No known drug allergies. Concomitant medication included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included BNT162B2 for COVID-19 Immunization [{product=COVID 19, brand=Pfizer, lot_number=EL9262, lot_unknown=False, administration_date=08FEB2021, administration_time=03:00 PM, vaccine_location=Right arm, dose_number=1}. Prior to vaccination, the patient was not diagnosed with COVID-19. Adverse_event was reported as 3-4 weeks after the 2nd dose experienced intermittent atrial fibrillation for over 3 weeks, then developed hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure. Adverse event start date: 29MAR2021, adverse event start time: 07:30 PM. Event treatment included telemetry monitor and 2 High BP Meds. Events resulted in: Doctor or other healthcare professional office/clinic visit. Event outcome was not recovered. The case was reported as Serious: No. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Atrial fibrillation,uncontrolled hypertension. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
63 2021-05-12 pulmonary embolism a blot clot discovered in lung within 2 weeks of first shot.; This is a spontaneous report from a co... Read more
a blot clot discovered in lung within 2 weeks of first shot.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number En6202, on 28Feb2021 10:45 at single dose in right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no covid prior vaccination. The patient had not tested covid post vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a blot clot discovered in lung within 2 weeks of first shot on 11Mar2021. The event resulted in Physician Office Visit. Treatment included blood thinner for blood clot. The outcome of the event was unknown. The event is serious with hospitalization and disability. Follow-up attempts are needed. Further information is expected.
64 2021-01-04 heart rate increased Vaccine given on 12/17/20 went to ER on 12/18/20 . Started having diarrhea at 4am on 12/18/2020. Cam... Read more
Vaccine given on 12/17/20 went to ER on 12/18/20 . Started having diarrhea at 4am on 12/18/2020. Came in to work and felt short of breath and heart rate increased. She went to the ER. She was given a liter of fluid 0.9% NACL IV, and per employee all symptoms resolved and she was discharged. She reports no further problems.
64 2021-01-06 lightheadedness Flu-like illness (fevers, rigors, chills) and one episode of presyncope due to orthostatic hypotensi... Read more
Flu-like illness (fevers, rigors, chills) and one episode of presyncope due to orthostatic hypotension upon getting up the day after the vaccine
64 2021-01-06 palpitations Post COVID vaccination (received on 12/14) Had MULTIPLE episodes of palpitations lasting several min... Read more
Post COVID vaccination (received on 12/14) Had MULTIPLE episodes of palpitations lasting several minutes. These palpitations started the evening of 12/14 and continued throughout 12/15/2020
64 2021-01-07 heart rate increased, hypertension Sever hot flash raising heart rate high blood pressure 192/112 the paramedics stay with me for an... Read more
Sever hot flash raising heart rate high blood pressure 192/112 the paramedics stay with me for an 1hr in a half I had high blood pressure it started 20min after the vaccine
64 2021-01-08 fast heart rate, hypertension Dizziness, HYPERtension & Tachycardia Narrative: 5 min after vaccine administered L arm felt dizzy. ... Read more
Dizziness, HYPERtension & Tachycardia Narrative: 5 min after vaccine administered L arm felt dizzy. 170/100, HR 133, 97% RA at 1220. Reported poor sleep and mild anxiety. 115/76, HR 116, 96% RA at 1234. At 1237 denies any dizziness or other adverse effects.
64 2021-01-10 hypertension 20 min after injection; BP 192/112, hot flushing, dizziness, blurred Lt eye. Hypertension continue... Read more
20 min after injection; BP 192/112, hot flushing, dizziness, blurred Lt eye. Hypertension continued for 1.5 hrs, however hot flush, dizziness and blurred vision Lt eye resolved.
64 2021-01-10 heart rate increased, blood pressure increased As per RN documentation, Pt with hx of anaphylaxis with the 4th infusion dose of Rotuxin a couple ye... Read more
As per RN documentation, Pt with hx of anaphylaxis with the 4th infusion dose of Rotuxin a couple years ago. PCP discussed benefit to prevent complications of COVID vaccine outweighs risk to get COVID vaccine. Discussed this as well with patient. She agrees to get the vaccine.   I stayed with the RN and patient for 30 minutes post vaccination and she had no symptoms other than BP and Pulse elevated further to 150s/90s. P upper 80s. She was transitioned to anther office with plan to continue observation for another 15 mins and recheck her BP.   About 45-50 mins post vaccine, she reported her lower arms and right side of her neck felt swollen but had no SOB or mouth swelling or itching. She was talking in normal sentences. Her face became more flushed as well as the posterior aspect of her forearms and she said the neck felt more swollen. Epi Pen was administered at 8:40 am and EMS was contacted. Her BP was 160/100, pulse ox 96%, RR 26, Pulse 88.   Transferred to ED.
64 2021-01-11 heart rate decreased, palpitations Customer rec'd COVID-19 vaccine at 0907 in facility and transferred to post vaccine observation. At ... Read more
Customer rec'd COVID-19 vaccine at 0907 in facility and transferred to post vaccine observation. At 0917 customer called out to provider. Customer reports "a funny feeling" and states that she has commonly felt this feeling prior to allergic reactions. She appears anxious. Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports "heart racing." BP 205/100, HR 121, 02 98%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 0920. Customer monitored at site. Over the course of the next 5 minutes she reports feeling better and more relaxed. HR decreases to 78, BP 190/78 @ 0930. Customer reports full resolution of symptoms. Reports having this type of reaction before to oral medications and has previously been monitored in the ED. She denies ever having to receive EPI, and is unsure what treatments were given in ED to resolve symptoms. She has never been admitted for one of these types of reactions, and reports this reaction as a mild compared to others. Customer's husband called to bedside. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1005, ambulating independently with steady gait, no obvious s/sx of distress.
64 2021-01-11 excessive bleeding Her INR was 5.8 (normal range 1 to 2)/increasing INR; Scratched arm; Scratched arm and bled through ... Read more
Her INR was 5.8 (normal range 1 to 2)/increasing INR; Scratched arm; Scratched arm and bled through 3 shirts, it kept bleeding; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EC1284), via an unspecified route of administration administered to left arm/deltoid on 29Dec2020 13:15 at single dose for COVID-19 immunization at a research medical facility; and received warfarin sodium (COUMADIN, strength 2 mg), oral (by mouth) from an unspecified date in 2017 and ongoing at "3 1/2 tablets once daily in the evening at 5:30pm (total 7mg)" for metal heart valve. The patient's medical history included had the surgery (for her metal heart valve), about 01Mar in 2017 (about 4 years ago) and so she thought she had been on Coumadin for about 4 years, had been on the 7mg dose for over a year; and has a history of metal heart valve and takes Coumadin for the metal heart valve. Denied illness. Denied family medical history relevant to event. There were no concomitant medications. The patient previously received Shingrix vaccine in past and remenbered she had the usual side effects from it, had mild symptoms. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not receive any other vaccines the same date of the Pfizer Suspect or 4 weeks prior. On Jan2021, the patient experienced scratched arm and bled through 3 shirts, it kept bleeding. On 04Jan2021, her international normalised ratio (INR) was 5.8 (normal range 1 to 2). The events did not lead to emergency room visit, however led to physician office visit. The events were reported as serious medically significant. The nurse got the first Pfizer COVID-19 shot on 29Dec2020 because she is a healthcare provider. She wanted information on increasing INR. The nurse has a history of metal heart valve and takes Coumadin. Her INR was typically 1.7 to 2.3. She reported her last INR, before the covid-19 vaccine was given, was "some time ago" but it had not varied much over the years. Normally she got her INR run and it was about 2. She had to be scheduled for her INR on the 04Jan2021 and it was 5.8 (normal range 1 to 2) and they asked about anything that may have changed and the only thing was that she got her first shot. The nurse reported not having any changes in her medications, food, or life style to account for the change, other than receiving the COVID-19 vaccine. The patient stated that it could be a serious problem if she had an accident or fell and started bleeding. A normal person's lab result is between 1 and 2, but they like to keep people with the metal heart valves between 2 and 3. She had been bleeding. She had barely scratched her arm the other day and went through 3 shirts because she kept bleeding. This is more than unusual for her, it's kind of unusual. Getting the vaccine is the only variant she has had since getting her last INR. The patient underwent lab tests and procedures which included INR (normal range 1 to 2): typically 1.7 to 2.3 on an unspecified date; it's about 2 on an unspecified date: and 5.8 on 04Jan2021. The action taken in response to the events for warfarin sodium was dose not changed. The outcome of the event INR was 5.8 was not recovered, for the other events was unknown. The nurse (patient) assessed the event "INR was 5.8; it's normally about 2" as related to the COVID-19 vaccine.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of International normalised ratio increased and wound hemorrhage due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-01-12 hypertension Immediately felt "strange" after receiving the vaccination. Developed hypertension, muscle aches, e... Read more
Immediately felt "strange" after receiving the vaccination. Developed hypertension, muscle aches, extremity swelling.
64 2021-01-12 fast heart rate PAIN INJECTION SITE,TIRE,MUSCULAR PAIN,JOINT PAIN,COUGH AND TARDICARDIAC.
64 2021-01-12 blood pressure increased felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous repor... Read more
felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous report from a contactable other HCP (patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided) via an unspecified route of administration (vaccination location: left arm) on 06Jan2021 09:30 at SINGLE DOSE for COVID-19 immunisation. Medical history was reported as 'none'. It was also reported that patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, and prior to vaccination, the patient was not diagnosed with COVID. The patient has no allergies to medications, food, or other products (no known allergies). The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899; expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 18Dec2020 18:00 at SINGLE DOSE for COVID-19 immunisation. It was reported that patient received second dose of Pfizer Covid vaccine on 06Jan2021 at 09:30 am. One hour after the 2nd dose (10:30 am), patient experienced dull occipital headache. Patient took paracetamol (TYLENOL). At 10:45 am, patient felt flushed. The nurse took patient's vital signs and noted no fever, normal heart rate and respiratory rate. BP elevated 226/97 (reported at 10:30, no unit provided; normal BP: 130's/80's). At 12:45, patient was taken to ED. CT scan and lab work were reported as all normal. BP continues to be elevated. Amlodipine (NORVASC) 10 mg was given at 17:00. BP slowly came down. Twenty-four hours later, BP was normal at 137/72 (no unit provided). No additional medication taken. It was reported that patient continues to have dull headache. No arm soreness or other symptoms. It was also reported that since the vaccination, the patient has not been tested for COVID-19. Outcome of the events 'BP elevated 226/97' and 'felt flushed' was recovering, outcome of the event 'dull occipital headache/dull headache' was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, the Company considers the reported event blood pressure increased is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-01-13 chest discomfort Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion;... Read more
Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion; chest tightness by day 3- increased swelling of arm with redness; hot to touch; increased pain radiating to under arm.
64 2021-01-13 fainting Systemic: Fainting-Mild
64 2021-01-14 oxygen saturation decreased Observed in her room having seizure activity and unresponsive to stimuli. BP of 200/120, oxygen leve... Read more
Observed in her room having seizure activity and unresponsive to stimuli. BP of 200/120, oxygen level dropped to 86%, HR was 116. She was transferred from Hospital A and later transferred to Hospital B and placed on a ventilator. This remains her current status
64 2021-01-14 heart rate increased, chest discomfort burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizzi... Read more
burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizziness; fast heartbeat; tiredness; Had a hard time swallowing at night from the dryness; bitter taste; her mouth went completely dry; patient received 0.45 mL, single dose (225mcg) of PFIZER-BIONTECH COVID-19 VACCINE; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 23Dec2020 15:00 at 0.45 mL, single dose (225mcg) at left arm to prevent COVID. Medical history included a bout of dry mouth about 7 years ago, no other relevant medical history (including any illness at time of vaccination). The patient's concomitant medications were not reported. There's no adverse events following prior vaccinations. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. From the time she got the vaccine her mouth went completely dry on 23Dec2020 and she kept thinking it would go away and she still had it. Event was reported as serious per medically significant. Had a hard time swallowing at night from the dryness. Patient had the bitter taste was also on 23Dec2020, but it went away. It lasted about 5-6 hours. Then after that the dry mouth started right after. It is tolerable but she still had it. Mentioned she had a bout of dry mouth about 7 years ago and it did go away, but she never got a diagnosis for it. Patient thought that something underlying may have triggered it again. Patient also experienced burning of the tongue, tiredness, headaches, pressure in the chest area similar to difficulty in breathing, nausea, dizziness, and a fast heartbeat on unspecified date. Outcome of event dry mouth was not recovered, outcome of event bitter taste was recovered on unspecified date in Dec2020, outcome of other events was unknown. No family medical history relevant to adverse events. No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Relatedness of Pfizer BioNTech Covid-19 vaccine with dry mouth and bitter taste per primary source reporter with method of assessment of global Introspection was related. Reporter seriousness for event bitter taste was not serious.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of dry mouth cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-01-15 fast heart rate shakiness, subjective feeling of tongue and throat swelling. mild tachypnea tachycardia = 80 no BP... Read more
shakiness, subjective feeling of tongue and throat swelling. mild tachypnea tachycardia = 80 no BP changes no rash no observed facial swelling or lip swelling but patient has dense right facial hemiparesis with preexisting asymmetry Epi pen administered, transferred to ED> solumedrol and Benadryl given IV and observation x 2 hours. home with oral prednisone x 5d dx "anaphylactoid reaction"
64 2021-01-17 blood pressure increased, chest discomfort, palpitations After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart... Read more
After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart was pounding check my BP 150/80 laid back down. I woke up around 5pm my BP had elevated to 160 (don't remember diastolic reading) pulse rate normal limits. I informed my spouse of what was happening called 911. At the hospital checked vitals, EKG, CT Scan, Chest X-ray, Blood work and Potassium was low took 2 Potassium pills. I went back home on 12/31 returned to work did fine that day. On New Years day everything started back again discomfort went back to ER. I felt like force in my chest the doctor collected my information and I was placed on a low dose BP medication until I return to my PCP, cardiologist(stress test). I followed up with PCP via Telehealth about my BP concerns, my dosage was increased to 25 mg and due to my symptoms I was placed on leave from work 2 wks. I also have a appointment scheduled with Neurologist.
64 2021-01-18 blood pressure increased, chest discomfort Employee felt flushed within 2 min of vaccine administration. Heart rate varied 56-68 Employee was... Read more
Employee felt flushed within 2 min of vaccine administration. Heart rate varied 56-68 Employee was observed and offered fluids and pretzels. 12:40- Bp 138/65, HR 62 100 % o2 sat. 14:00 156/80 68 100% on RA Lungs CTABL rrr no murmer. Employee was discharged to home. 1/15 Called employee for follow up and employee reported that she experienced intermittent chest pressure x approx 2 days at home and elevated BP which resolved on 1/1/21 had taken losartan 25 in the morning, thend again after COVID vaccine and again before bed. Employee was referred to contact PMD to assist in determining if secondary dose is okay to receive or if she will need cardiac eval. Employeee was referred to Oc health clinic, examined and discharged with recommendation to double losartan before next vaccine and talk to PMD before second dose of covid vaccine. Employee was also provided with the PFIZER number to report this to Pfizer.
64 2021-01-18 blood pressure decreased, blood pressure fluctuation Patient received the vaccine at 8:01 and at 8:10 patient felt lightheaded (like she was going to pas... Read more
Patient received the vaccine at 8:01 and at 8:10 patient felt lightheaded (like she was going to pass out.) Patient was given ice packs and continued to feel same. Patient was lowered to the floor (BP 79/55, HR 83, O2 sat 98%). Patient felt much better supine. with legs elevated BP 110/69. Patient feeling much better and was put sitting in chair. BP 122/81. Felt much better, did not want to go to ED. Patient given juice and snack. Pt stated she felt fine. Time increased for observation. at 8:40 patient began to feel lightheaded again. Lowered to floor, BP 78/58 HR 65 o2sat 98%. Patient stated felt fine. Rapid response called and patient transferred to Emergency Department. BP 98/72, HR 71, O2sat 100%.
64 2021-01-19 loss of consciousness Pt passed out & shaking (possible seizure) shortly after injection. 911 called. Pt conscious after ... Read more
Pt passed out & shaking (possible seizure) shortly after injection. 911 called. Pt conscious after 1-2 minutes. Declined transport to ER. Monitored by RN and pharmacist for 45 min. Pt's husband drove her home when status returned to normal
64 2021-01-20 lightheadedness, pallor Vaccine recipient c/o near syncope to RN monitor in the vaccination clinic. Cool, pale, dry skin. ... Read more
Vaccine recipient c/o near syncope to RN monitor in the vaccination clinic. Cool, pale, dry skin. She placed her head on the table and asked for help. RN monitor requested assistance. Patient had strong pulse, no respiratory difficulties, no hives noted but was unable to stand. ED Charge nurse notified and ED RN transported patient to the ED via gurney without incident.
64 2021-01-24 chest pain, hypertension Pain/deep pain in the chest, hypertension, SOB. Was seen at Hospital ER where they did lab work, EK... Read more
Pain/deep pain in the chest, hypertension, SOB. Was seen at Hospital ER where they did lab work, EKG, and CXR. Employee's symptoms resolved while in the hospital and employee was realeased home and back to full duty.
64 2021-01-24 chest discomfort, blood pressure increased, palpitations forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most... Read more
forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation. Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
64 2021-01-25 chest discomfort Heaviness in chest; Chills; Headache; Body aches; 20 Hours after vaccination; fever of 100.5; This i... Read more
Heaviness in chest; Chills; Headache; Body aches; 20 Hours after vaccination; fever of 100.5; This is a spontaneous report from a contactable Nurse reported for herself. A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 16:00 at single dose on left arm for COVID-19 immunisation. Medical history included Anxiety, GERD, gluten and lactose intolerant, no known allergies, no COVID prior to vaccination. There were no concomitant medications. There were no other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 in Dec2020 13:00 in Left arm for COVID-19 immunization. About 20 Hours (as reported) after vaccination, on 14Jan2021 at 11:00 AM, the patient experienced fever of 100.5, headache, body aches, heaviness in chest, chills. No treatment was received for the events. The patient had not recovered from the event. The patient didn't test COVID post vaccination. Information on the lot/batch number has been requested.
64 2021-01-26 fast heart rate 45minutes to an hour after the vaccine I went into SVT. I went to the emergency room and got adenosi... Read more
45minutes to an hour after the vaccine I went into SVT. I went to the emergency room and got adenosine. Don?t know if this was a reaction or coincidence. I waited the 15 minutes and walk Ed to my car and went into SVT.
64 2021-01-26 chest discomfort At 9:53am patient reported "pressure" in her chest. Patient described pressure as if what she may ex... Read more
At 9:53am patient reported "pressure" in her chest. Patient described pressure as if what she may experience with asthma. Patient denied chest pain. Vitals taken every 5 minutes. Patient declined supplemental oxygen. Patient declined IM Benadryl. Patient administered 50mg of oral diphenhydramine at 9:55am . Patient refused to go to ER. Patient was alert and oriented x4.
64 2021-01-26 loss of consciousness, blood pressure increased, fainting Became unresponsive and was unarousable to sternal rub. A code blue was called and she woke up. Her... Read more
Became unresponsive and was unarousable to sternal rub. A code blue was called and she woke up. Her BP was elevated (176/120) and HR 45, o2 sat 100%, RR 16. About 15 minutes later, she had a repeat syncopal episode and was transferred to the emergency dept
64 2021-01-26 blood pressure increased Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving d... Read more
Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving dose, felt extreme coldness from shoulder to tips of fingers for about 30 mins and then resolved. Then afterwards, started to develop redness/itching/hives on back. Patient also felt very lightheaded and blood pressure taken and elevated at 188/84. (20-25 mins after injection). Injection site did swell and got red after. Also had mild HA after arriving home but didn't last long & nauseous feeling the whole day after getting vaccine. Patient did not take any medications and all symptoms resolved on own.
64 2021-01-26 cardiac arrest cardiac arrest - no warning signs
64 2021-01-27 heart rate increased Approximately five minutes after receiving a COVID vaccine patient c/o heart beating fast. She had n... Read more
Approximately five minutes after receiving a COVID vaccine patient c/o heart beating fast. She had no complaints of trouble breathing, tongue or throat swelling, or rash. There were no hives, rash, wheezing, flush. Patient was alert, NAD. BP 116/74, P74 O2 sat 94%. Patient observed for 40 minutes. No further episodes of rapid heart rate. BP upon discharge was 135/73, P 64 and O2 Satu 96%
64 2021-01-28 heart rate increased High heart rate, 125. high respiration, 110, severe coughing. They started IV OF SODIUM CHLORIDE... Read more
High heart rate, 125. high respiration, 110, severe coughing. They started IV OF SODIUM CHLORIDE, GAVE ME STERIODS, AND LORATIDINE, AND SOMETHING ELSE. WAS IN EMERGENCY FOR 4 HOURS. STILL COUGHING, HEADACHE, FEVER NOW 24 HOURS LATER
64 2021-01-28 fast heart rate Patient experienced tachycardia/anxious during 15 minute monitoring period after receiving first dos... Read more
Patient experienced tachycardia/anxious during 15 minute monitoring period after receiving first dose of Pfizer lot# EK9231. Patient was kept for an additional 15 minutes and improved within 10 minutes of the dose. Patient received vaccine on 1/15/2021.
64 2021-01-28 chest discomfort She described feeling of shortness of breath and self-administered Albuterol inhaler (home med). Con... Read more
She described feeling of shortness of breath and self-administered Albuterol inhaler (home med). Continues feeling short of breath, now with chest heaviness. BP 148/74, HR 123, RR 26, p.ox 100%. Sent to critical bed immediately on report of chest heaviness. Treated with Prednisone, Claritin, Famotidine
64 2021-01-29 chest discomfort COVID- 19 Vaccine. She was experiencing chest tightness, SOB, and dizziness. 50mg of Benadryl and 20... Read more
COVID- 19 Vaccine. She was experiencing chest tightness, SOB, and dizziness. 50mg of Benadryl and 20mg of famotidine was administered around 1410. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3mg of epinephrine was administered at 1420. EMS was called. Breathing improved. Pulse ox 100%, HR 68, BP 130/89. EMS arrived and assumed patient care. Pt seen in Emergency Room 1/16/2021 1513 CHIEF COMPLAINT: reaction to COVID vaccine HISTORY OF PRESENT ILLNESS: Patient is a 64y F with PMHx significant for Myopericarditis, Anxiety and HTN who presents to ER after developing tongue swelling, wheezing, tunneled vision and shortness of breath. Patient states that she was getting first shot of COVID19 Pfizer vaccine at 2:00 pm. After getting vaccine she waited 15 minutes like she was told and recalls room getting very hot at approximately 6 minutes after getting vaccine. She also states that her tongue felt swollen. She then noticed her vision started to turn dark and then she felt dizzy. She told pharmacist about symptoms and then she was given one pill of Benadryl. This did not help and actually made her symptoms worse. She recalls wheezing. She was given another pill of what she believes was Benadryl. She also recalls pharmacist measured her BP and her husband, who was present, reported that her blood pressure was in the 140s This did not improve so she was given 0.3mg IM epinephrine shot. This significantly improved her symptoms. However, she was sent to ER. She denies any hx of recent UTI or GI infection. She denies fevers, chills, nausea, diarrhea, chest pain, generalized itching, vomiting, abdominal pain, generalized swelling, headache or syncopal episode. She denies any past reactions to vaccines. She denies current SOB and feels like her symptoms resolved. Denies hx of COPD or asthma. Physical exam did not show any recurrent signs of wheezing or tongue edema. Her SaO2 was 100% on RA and BP was within baseline 140-160s. Given episode, we decided to obtain tryptase levels. We also observe patient to ensure she did not have any recurrence of symptoms. She remained hemodynamically stable and SaO2 remained in mid 90s to 100. She was given a rx for epinephrine pen should symptoms recur though this is highly unlikely as she remained stable throughout ER stay. She was also given instructions to pick up OTC Benadryl and Pepcid. She does have antihistamines listed as an allergy but patient states that she gets tachycardic upon taking tabs, so this could just be a side effect. We will follow up with tryptase levels but even if tryptase levels return as normal, it does not mean she did not have an anaphylactic reaction to vaccine. Her clinical picture puts this diagnosis high in the differential. Teaching and instructions were given to patient and her husband. She was advised to return to ER if symptoms recur. IMPRESSION: Anaphylaxis Anxiety attack
64 2021-01-29 heart flutter Chills, fatigue, heart flutters
64 2021-01-29 fast heart rate, hypotension Pharmacy was called by outpatient provider, Dr regarding a reaction in a patient who received their ... Read more
Pharmacy was called by outpatient provider, Dr regarding a reaction in a patient who received their 2nd dose of the Pfizer Covid-19 vaccine (lot EL3247) on 1/21 at LMC. On 1/22, the patient reported with tachycardia, hypotension and arm numbness. Dr was concerned that the injection was given too high on the patient's arm and potentially into the shoulder joint. Patient was directed to the LMC ED for treatment. The patient was given fluids and was discharged home. The ED provider did not believe the vaccine was given into the joint.
64 2021-01-31 blood pressure increased Approx 8 minutes after receiving the vaccine client started c/o feeling pressure behind her eyes. Sh... Read more
Approx 8 minutes after receiving the vaccine client started c/o feeling pressure behind her eyes. She has had this problem before and thinks it is because her blood pressure is elevated. Client was not feeling well enough to drive home so her husband came and got her. She said after she was home for a few minutes she felt better. She was able to pick her car up within 2 hours of the incident. She did call her PCP and let them know.
64 2021-01-31 chest discomfort, chest pain Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever ... Read more
Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever of 99, fatigue, pronounced pain in arm and shoulders
64 2021-01-31 blood clot Superficial blood clot in right medial knee area. Aspirin, elevate right leg, compression and heat.
64 2021-02-01 heart rate increased, chest discomfort, cardiac arrhythmia Normal sinus rhythm but throwing PVCs; Elevated pulse with chest tightness; Elevated pulse with ches... Read more
Normal sinus rhythm but throwing PVCs; Elevated pulse with chest tightness; Elevated pulse with chest tightness; A little atelectasis in lower left lung; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left deltoid on 14Jan2021 09:00 at single dose for covid-19 immunization. Medical history included ongoing does not have a thyroid; allergies/intolerance to gluten and dairy, allergies to molds, dust and some seasonal allergies; all ongoing. Concomitant medication included levothyroxine from Feb2013 to unspecified date, from unspecified date and ongoing for "does not have a thyroid". The patient previously took codeine and experienced allergic reaction occurred at 13 years of age with unknown cough syrup with codeine, levaquin and experienced allergic reaction occurred probably while she was in her 20s (age in years). She had fallen asleep on the couch about 9:00 pm on 14Jan2021. She woke up about 9:30 pm on 14Jan2021 and had an elevated pulse with chest tightness. She had to go to the emergency room in response to elevated pulse with chest tightness. In the emergency room they were not able to do anything other than hydrate her and all of that but it took about 12-13 more hours for her elevated pulse to come down (15Jan2021). Her biggest question was that she saw where some reactions are fast heart beat but she was kind of surprised at how long after the dose was administered that she had onset of the elevated pulse. She saw Cardiologist 18Jan2021 related to this event and the Cardiologist was a little baffled by the event. She reported event as improved, although she still has a little bit of tightness in her chest which goes in a little bit of phases. The Cardiologist told her to still take the second dose as scheduled of the Pfizer COVID-19 Vaccine. She did not see her family doctor, she saw the Cardiologist only as referred after emergency room visit. She was not admitted to the hospital; she was treated and kept under observation in the emergency room for about 5.5 hours. She has a stress test scheduled for next week. She is planning to still get the second dose as scheduled of Pfizer COVID-19 Vaccine but she is a little scared to get it due to this adverse event. She thought the events were related with the vaccine, she had no problem prior to getting the vaccine. On 14Jan2021, pulse was 146 beats per minute which she checked with a pulse oximeter machine she has at home so she knows it is accurate; Chest x-ray: She reported that result of a little atelectasis in lower left lung was a little weird. On 18Jan2021, the EKG result was Normal sinus rhythm but throwing PVCs. She reported she knows her thyroid lab is normal because it was checked in the emergency room during visit starting 14Jan2021. The outcome of the events elevated pulse with chest tightness was recovering, other events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-02-01 blood pressure increased, chest pain felt really sick; chest pain; bad headache; it spiked blood pressure the very first day/Her blood pr... Read more
felt really sick; chest pain; bad headache; it spiked blood pressure the very first day/Her blood pressure spiked the first day; This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on left arm on 28Dec2020 at single dose for COVID-19 prophylaxis. The patient medical history included: Chronic hypertension and elevated cholesterol levels. Concomitant medication included ongoing acetylsalicylic acid (BABY ASPIRIN) for chronic hypertension and elevated cholesterol levels, then developed GI problems and she skipped days. On 28Dec2020 she received the 1st dose of the Pfizer vaccine. She was scheduled for her 2nd dose on 22Jan2021 (Friday). The patient developed a bad headache on 28Dec2020 that evening was better by the next morning then came back, it spiked my blood pressure the very first day, it usually responded to the medication but this time it didn't. The patient's blood pressure stayed like that for 2 to 3 days, she felt really sick on unknown date, on the 3rd day on 31Dec2020 the patient had some chest pain, but later that day she was feeling back to normal. Right now she felt fine, her blood pressure was back to my normal, baseline. Weight 153-154 lbs. Reporter said that what concerned her most was that her blood pressure spiked. She said that has never happened in the past that with her blood pressure before. Her blood pressure did not respond to her medication. The patient was trying to research the high blood pressure and hadn't been able to find any information and want to know if there was any information can provide. The patient wanted to take the vaccine, she just wanted to be sure she would be okay. The outcome of event headache was not recovered. The outcome of events blood pressure increased and chest pain was recovered on unknown date. The event of rest event was unknown.
64 2021-02-02 blood pressure increased, palpitations Flushing 10 min after injection followed by heart palpitations then increased blood pressure. I too... Read more
Flushing 10 min after injection followed by heart palpitations then increased blood pressure. I took 2 loratidine tablets and symptoms slowly subsided over the next 50 min. The next day had chills and nausea for 8-10 hr. The nausea lasted another 3-4 days.
64 2021-02-02 chest pain, chest discomfort Pt reported chest pressure and pain 1 hour after receiving her 2nd Pfizer vaccine. Negative cardiac... Read more
Pt reported chest pressure and pain 1 hour after receiving her 2nd Pfizer vaccine. Negative cardiac work up in emergency department but she has a history of pulmonary embolism so she was admitted to the hospital for observation and further work up with no definitive diagnosis
64 2021-02-02 fainting faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a sponta... Read more
faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a spontaneous report from a contactable physician (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3426, expiration date: unknown), via an unspecified route of administration on the left arm on 16Jan2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included cardiac hypertrophic cardiomyopathy. The patient has no known allergies. Concomitant medications were not reported. No other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 24Dec2020 at the age of 64 years old, lot number: Ek9231. On 16Jan2021 at 11:00 PM, the patient experienced faintness, fevers at 101.5 and 102.7 (on day 3), myalgia, fatigue, tracheitis for 3.5 days- stopped around 4AM on Wednesday, and respiration rate of 40. The patient has no COVID prior vaccination and has not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.5 on 16Jan2021, heart rate (HR): 80 on 16Jan2021, respiration: 40 on 16Jan2021 and body temperature: 102.7 on 20Jan2021. No treatment was administered for the events. The patient recovered from the event tracheitis on 20Jan2021 at 04:00 while recovering from the rest of the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Faint cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-02-02 hypertension, blood pressure increased muscle swelling; welts/hives; muscle pain; eyes swelling; tongue swelling; shut throat; blood pressu... Read more
muscle swelling; welts/hives; muscle pain; eyes swelling; tongue swelling; shut throat; blood pressure elevated; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiration date not reported), via an unspecified route of administration on 17Dec2020 15:15 at single dose on right arm for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. No Known allergies to the patient currently. The patient was not pregnant. Concomitant medication in two weeks included Rosuvastatin. The patient received the vaccine in hospital. No other vaccine administered in four weeks. The patient experienced muscle swelling, welts/hives, muscle pain, eyes swelling, shut throat/tongue swelling, and blood pressure elevated hospitalization continued symptoms now for 35 days. All adverse events (AEs) started on 17Dec2020. AEs resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization for two days. Patient received treatment (medications, IV's EKG many test) for AEs. No COVID prior vaccination. Patient did COVID tested post vaccination, COVID test post vaccination included Nasal Swab on 02Jan2021 with result of Negative. The outcome of events was not recovered.
64 2021-02-03 lightheadedness at 3:22, Pt waved down (EMT) on site. Clt sitting in vaccination observation area. C/o feeling hot,... Read more
at 3:22, Pt waved down (EMT) on site. Clt sitting in vaccination observation area. C/o feeling hot, dizzy, and lightheaded with vasovagal like symptoms. Pt moved to reclined position, and reported immediate relief. Vitals taken at 3:35: BP 132/90, 66 HR. Denies other s/s allergic reaction. Clt sat up 8 min later, states symptoms resolved. Clt completed Vaccine observation period, ambulated self to bathroom and left site at 3:46 pm.
64 2021-02-03 heart rate increased more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; Th... Read more
more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine), intramuscularly on 15Jan2021 at single dose into the left arm for COVID-19 prophylaxis. Medical history included asthma; blood pressure abnormal (she takes blood pressure medication); palpitations at times; having mild chest discomfort, had experienced this before, that she was attributing to her wearing a mask, she wore 2-3 masks; stated that she had Covid once and she did not want it again. Concomitant medications included some blood pressure medication, and salbutamol (ALBUTEROL) inhaler periodically. Caller is a LPN nurse that was calling about the Covid-19 vaccine and reported that she received it Friday 15Jan2021 and just wanted to report some mild side effects. Caller clarified that she was more tired, had weakness, had diarrhea for 2 days, increased heart rate, and a runny nose, soreness at the injection site . She stated that she was not in a lot of distress. More tired started from 17Jan2021 and soreness at the injection site started from 16Jan2021. Weakness started from 17Jan2021: She stated that went home straight from work and went to the couch and slept about 6 hours. She had been up since 0300 and it was almost 1200 now. She stated that her energy level and weakness was pretty good right now. Diarrhea started from 16Jan2021: She said that she had the urgency to go and it was definitely soft and foul like when you had the flu. She stated that she has had it once since this morning. It was semisolid. Increased heart rate started from 17Jan2021: she felt palpitations at times. She said that she did not know if they were related, but stated that they were aggravating yesterday. She stated that she took blood pressure medication. She stated that she used a inhaler albuterol. She was using her inhaler periodically and said that it could be because of the albuterol inhaler. Runny nose started from 15Jan2021: Runny nose started about 8-10 hours after her injection. Stated that it was not bad, she would just have to blow her nose really good every so often. She said that she has not had to blow her nose today since she had been up. She said that the vaccine was sitting on the table and they just told her it was the Pfizer BioNTech vaccine. She did not have her vaccination card with her at the time of the call. The patient had recovered from weakness on 18Jan2021, recovered from increased heart rate and soreness at the injection site on 17Jan2021; she was recovering from more tired, runny nose, and she had not recovered from diarrhea. Reporter seriousness for increased heart rate, runny nose and soreness at the injection site was not serious. The reporter (nurse) considered the events more tired, weakness, diarrhea, runny nose and soreness at the injection site were related to bnt162b2, and relatedness of bnt162b2 to reaction increased heart rate was unknown. Information on the lot/ batch number has been requested.
64 2021-02-04 heart rate irregular Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tirednes... Read more
Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tiredness & fatigue, foggy brained, extreme body aches and pain, unable to walk from weakness, nausea, excruciating headaches, irregualar heartbeat, nausea. Reddness and swelling in arm for over 1wk. Nausea about 10 days.
64 2021-02-05 palpitations Dizzy Heart Palpitations Shortness of Breath Tingling of Lips & Tongue Swollen Face Head Pain Throa... Read more
Dizzy Heart Palpitations Shortness of Breath Tingling of Lips & Tongue Swollen Face Head Pain Throat Tightness
64 2021-02-08 fainting, palpitations 37 hours after Pfizer injection, experienced severe abdominal pain that caused me to have vasovagal... Read more
37 hours after Pfizer injection, experienced severe abdominal pain that caused me to have vasovagal syncope. Started sweating, and I lost my vision, then must have fallen on the floor. When I came to, felt very headachy and nauseous. went to urgent care - they ordered an abdominal scan for 2/8/21 but scan did not reveal the cause of the pain. 8 hours later on 2/5/21, started feeling asthma like symptoms. Throat felt tight, voice became hoarse, kept having to cough because airway was starting to feel thickened. went to ER, they took vitals and told me that i wasn't having an allergic reaction because my symptoms were outside the time frame for an allergic reaction. After 3 hours there, they sent me home. Next morning felt like I was having heart palpitations. that feeling eventually went away if I walked around. But the following two mornings, I had the same feeling.
64 2021-02-10 chest discomfort, blood pressure increased Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; ... Read more
Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl most likely contributed to the events as the patient is known allergic to antihistamine tabs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
64 2021-02-14 heart rate increased fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, ... Read more
fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, back of the neck/headaches and pain, disoriented, injection site swelling, tenderness, and hot to the touch, fever, sinus infection like symptoms ( stuffiness, difficulty breathing, ear pain, sinus/facial pain )
64 2021-02-15 palpitations At 6:30 p.m. I began with palpitations of heart, lasted about 90 minutes. The palpitations were in... Read more
At 6:30 p.m. I began with palpitations of heart, lasted about 90 minutes. The palpitations were intermittent. The night and next day I had musculoskeletal pains, and tiredness. The primary thing I would like to report is that starting on Saturday, Feb. 13th around 8 pm, I began with a cold sore, or fever blister of upper lip. Over the course of the next 24-36 hours, I developed at least 4 more fever blisters. I am not prone to fever blisters, and have never in my life had more than one, infrequently. They are on upper and lower lip, and one is even immediately below my lip, on my skin that is not mouth mucosa. They are painful .
64 2021-02-16 heart rate decreased patient was vaccinated at 0801. After 15 minutes patient started feeling light headed and weak. Vita... Read more
patient was vaccinated at 0801. After 15 minutes patient started feeling light headed and weak. Vital taken. patient was monitored until 0842 with little improvement in symptoms and pulse was low. Patient was transferred to urgent care , and checked in for further evaluation,
64 2021-02-18 heart rate irregular, heart rate increased Symptoms: Nausea; Rapid and Skipping Heartrate. Duration: 3 Days
64 2021-02-19 chest pain, palpitations, hypertension, heart rate increased, heart rate abnormal Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simulta... Read more
Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simultaneously I felt my heart racing and feeling flush. I raised my hand to alert attendant. Took pulse and it was very high. They called EMT. Upon connecting me to heart monitor is was erratic, Very high blood pressure. When they touched chest it hurt more. They said I was bright red. They transported me via residue to Hospital. Residual mild rash under skin for several days. Had severe headache for 14 hours.
64 2021-02-22 blood pressure increased 10 mins after 2nd dose, pt started having upper back itchy feeling. Came to nurse observation area.... Read more
10 mins after 2nd dose, pt started having upper back itchy feeling. Came to nurse observation area. no rash observed. BP elevated.
64 2021-02-22 heart rate increased C/o feeling hot flush heart rate 104. Denies no dizziness, nausea, chest pain, or SOB. EMS evaluate... Read more
C/o feeling hot flush heart rate 104. Denies no dizziness, nausea, chest pain, or SOB. EMS evaluated P 94 148/99. Ok to walk with husband as nd left for home w husband 12:26 pm.
64 2021-02-24 increased heart rate, hypertension Lightheadedness, Dizziness, HTN, patient with severe anxiety, EKG done via EMS, Sinus Tachycardia.
64 2021-02-24 chest pain Radiating sharp pain that started in neck, then went to L of chest to L upper arm. Evaluated by EMS... Read more
Radiating sharp pain that started in neck, then went to L of chest to L upper arm. Evaluated by EMS, cleared.
64 2021-02-25 blood pressure increased, transient ischaemic attack In 4 hours, started getting getting very dizzy, then throwing up, and nauseous by 7:30pm felt Luke o... Read more
In 4 hours, started getting getting very dizzy, then throwing up, and nauseous by 7:30pm felt Luke on worse six flag ride. Blood pressure went up to 166/106. Called 911. Diagnosed with possible reaction and developed TIA
64 2021-02-25 hypertension Patient started having tingling in her lips 5 days after the injection, then she began having a sore... Read more
Patient started having tingling in her lips 5 days after the injection, then she began having a sore throat, she started having a hoarse voice and she felt very tired. 911 was called. In route they were transporting patient she was hypertensive had normal heart rate they gave her Benadryl 50 mg orally and then epinephrine 0.3 mg IM which did not help patient at all.
64 2021-02-25 chest pain RASH, DYSPNEA, CHEST PAIN, FEVER JOINT PAIN, CHILLS, FEVER. TREATMENT: KENALOG, BENADRYL, PEPCID.
64 2021-03-01 blood glucose increased, blood pressure increased 7:00 PM - 2 hours after the vaccination I felt very hot. I was not running a fever. I started shakin... Read more
7:00 PM - 2 hours after the vaccination I felt very hot. I was not running a fever. I started shaking uncontrollably. The shaking was not chills. My husband took me to the emergency room. This was their summary. Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar level; Myoclonic jerking; Vaccine reaction 10:00 PM Left the clinic. Went home and slept. I saw my general practitioner the following day and everything was back to normal. I am allergic to something in the vaccine and I am unsure of getting the second dose.
64 2021-03-01 heart rate increased, palpitations Heart palpitations, elevated HR- Evaluated by EMS-Cleared
64 2021-03-04 fast heart rate Dizziness, nausea, SOB, HTN and tachycardia
64 2021-03-04 chest pain I had severe COVID and was hospitalized on Dec 7, I was in hospital (non ICU setting) for 5 days an... Read more
I had severe COVID and was hospitalized on Dec 7, I was in hospital (non ICU setting) for 5 days and had O2, remdisiver and dethemethzone IV. I recovered fully, and have felt very good since mid January. My reaction after my 1st dose of vaccine on Feb 25 started 20 hours after shot. Worsened through the day and I got sicker at 24-36 hours, and then stayed in bed another day. Symptoms were identical to my bout with COVID: chills (no fever), nausea, aches in joints and muscles, fatigue. They were quite significant==I could not be out of bed. As it went along I also developed the feeling in my chest like COVID--tough to take deep breath, chest hurt---but my O2 readings were fine. Recovered after 48 hours, People who have had COVID should be aware that they will have a significant response to the vaccine on the 1st does. I am questioning having a second dose I have not reported this to my doctor
64 2021-03-04 chest pain Nausea, vomiting, pain under breastbone , tired unable to eat, has stayed in bed basically from the... Read more
Nausea, vomiting, pain under breastbone , tired unable to eat, has stayed in bed basically from the evening of 02/25/2021 through 03/05/2021.
64 2021-03-06 chest discomfort Approximately 17 hours after vaccine, suddenly got very tired, brain fog, and had some type of sleep... Read more
Approximately 17 hours after vaccine, suddenly got very tired, brain fog, and had some type of sleep attacks, yet couldnt sleep, head just nodded up and down. felt very hot suddenly from the sides of the throat down straight and under both breast, felt as if I was being squeezed to death. chest felt very heavy. yet not gasping , or breathing fast. Im a respiratory therapist disabled now. I took bp was 120/80, o2 sat was 97, heart rate was 16, pulse 83. I could not lie down as felt as if being smothered. had to lie down but elevated very high. felt as if throat and chest were hot, but i did not get up to see if red, as i was having severe brain fog and oh so sleepy, yet felt so wired on friday evening March 5,2021 when I had the shot. I was awake, this tiredness and heaviness didnt happen until 1pm the next day. Saturday evening, I took o.1 ativan , thinking it was maybe anxiety as the brain for cleared after 3 hours, the chest heaviness got better, but still persisted over to sunday, march 7, but throat feeling closed in dissipated after 3 hours on saturday. 3/6. Sunday still unable to lie down as chest still felt heavy, bp 140/80 which was elevated. pulse elevated, respirations were 20. however all side effects seemed to be subsiding
64 2021-03-06 palpitations, cardiac arrhythmia This 64 year old female experienced an adverse event. At baseline, she presented in a wheelchair. Wi... Read more
This 64 year old female experienced an adverse event. At baseline, she presented in a wheelchair. Within 5 minutes after vaccination, she complained of a racing heart, a new onset tremor of hands and head, and slurred/stuttering speech. She denied chest pain, shortness of breath or itching. No facial droop or one-sided weakness was observed. The patient had a history of hypertension and history of an adverse reaction to albuterol in November 2020. The patient described being nervous to get the vaccine due to her previous reaction to alberterol which had the similar effects as today's. The patient's new tremor worsened, and speech became more slurred and stuttered while we observed her. The patient denied any pain and described a similar event that caused her to be hospitalized for a week with no definitive diagnosis. Her primary care doctor had cleared her to get the vaccine. Her Vitals were as follows: BP 160/90. HR 65, RR 20. Heart sounds were regular with occasional PVC's. Lung sounds were clear No visible rash on neck, trunk or injection site. Capillary refill was normal. Mild edema in both lower extremities. No swelling of the lips. No visible droop in facial muscles. Patient was tearful and struggled to speak. She repeatedly said she was tired. She reported nausea. EMT was called and found similar vitals and O2 saturation at 100% on room air by pulse ox. O2 via nasal canula was begun. Rhythm strip showed NSR. Patient refused transport to the hospital for further evaluation. She was informed of a possible Transient Ischemic Attack (TIA) could be occurring which could need a blood thinner and further work up. Patient was tearful saying her previous hospitalization was traumatic and did not want to return. EMS offered her transport to another hospital facility via private vehicle, and she refused. We offered to contact her primary care doctor and she also refused. She was concerned about the cost of a hospital stay if she signed out AMA. EMS left the facility and offered to return if the patient changed her mind. The patient's symptoms had not resolved by 4:30pm. The patient's son, by phone, confirmed she would be monitored until 5pm. She was driven home by one of our staffers. The next day, the patient told our staffer that she felt well. She said it took about 7 hours for her speech to return. She said her head, stomach and body felt better in the morning. She said she going to see an allergist as her doctor recommended. Our presumed diagnosis was a TIA related to uncontrolled HTN with anxiety.
64 2021-03-07 heart rate increased My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling u... Read more
My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling unwell difficulty breathing a fast heartbeat weakness
64 2021-03-07 fast heart rate flushing, dizziness, tachycardia
64 2021-03-08 chest discomfort At 9:55 client complained of 'something sitting on my chest'. Stated she is 'allergic to unknown sub... Read more
At 9:55 client complained of 'something sitting on my chest'. Stated she is 'allergic to unknown substance'. Vitals were stable throughout the incident and at 10:10, client stated that the pressure was relieving.
64 2021-03-08 palpitations, hypertension Face turned red, and then numb, hard to breathe, and felt like heart beat quicken, and felt like pas... Read more
Face turned red, and then numb, hard to breathe, and felt like heart beat quicken, and felt like passing out. Lasted for about 3 minutes.
64 2021-03-09 heart rate increased Increased heart rate from 7:30pm to approximately 3:00 am. Reaching up to 130 beats per minute and t... Read more
Increased heart rate from 7:30pm to approximately 3:00 am. Reaching up to 130 beats per minute and this all occurred while resting on the couch. I stayed in constant contact with my family. I have a fitbit that alerted me and recorded the event
64 2021-03-10 platelet count decreased I developed a 3?x4? bruise 5-6 inches away from my injection site 10 days after my 2nd dose. It?s p... Read more
I developed a 3?x4? bruise 5-6 inches away from my injection site 10 days after my 2nd dose. It?s painful and has a dime size lump inside, looks like it?s getting bigger every day. I have a hex of low platelets, last December is 145 , took it again 3/1/21 and it?s 116 , I don?t know what?s going on , Saw my PC , he sent me for ultrasound. Please advise what to do.
64 2021-03-10 blood glucose increased Patient is a 64 y.o. female admitted for acute DKA, glucose is 771 Severe ketoacidosis, bicarb is o... Read more
Patient is a 64 y.o. female admitted for acute DKA, glucose is 771 Severe ketoacidosis, bicarb is only 7 AKI, pseudohyponatremia K 5.3 LFT's ok Got the covid 19 vaccine 2 days ago She has sore throat and chills She did vomit up coffee ground material
64 2021-03-11 hypotension 64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt repor... Read more
64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt reports got her second covid vaccine on 3/92021 in the left arm, Pfizer. Yesterday (3/10/21) woke up with severe right knee pain, felt like she could not bear weight/ws going to fall. She went to son's apartment who is in same building and then went to lie down in bedroom. Because she drinks a lot of water, she had to get up to go to bathroom to urinate. She was about to sit down on toilet, when she felt both her legs go numb as well as her arms and her vision was blurred. She tried to grab the tub but fell forward on the floor. She states she urinated on the floor. She was on the floor for about 30 mins until her son got her up and back to bed. Later in the day she needed to urinate again and when she got up, she felt unsteady and fell on the bureau bruising the left arm. Since she feels a bit unsteady with gait and used a walker to come hre today. She denies feeling dizzy before her falls. She denies striking her head. She denies convulsions or hx of seizure disorder. She reports no new meds, only recent change an increase in her alprazolam dose. She does report a headache day after her vaccine.'She denies vomiting or diarrhea or antecedent illness. No longer has headache. She denies positional changes Of note she is on propranolol (prescribed by psych) as well as lisinopril-hydrochlorothiazide for HTN 64 yo female with bipolar disorder on multiple psych meds, htn on propranolol 20 mg bid and lisinopril-hydrochlorothiazide, s/p recent Pfizer covid vaccine, s/p presyncope episode after experiencing severe right knee pain and attempted micturition. Pt felt like her sight was affected and experienced numbness/weakness in legs and arms causing a fall. Did not hit head. The history is most suggestive of a vagovagal episode.
64 2021-03-11 chest discomfort Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, ... Read more
Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, general "dumpiness" ~9 days after: Tender joints in toes, leg pain and weakness, dry, irritated, blurry eyes, brain issues: dizzy, word retrieval issues, derealizing Feb 11: fatigue, muscle weakness and pain in legs Feg 12: headache, heavy feeling in chest, continuing leg pain and weakness. March 12 Pain in legs persists, but improved, brain issues improving, but not resolved, eyes still somewhat dry and blurry/strained
64 2021-03-11 chest pain, fast heart rate Shortness of breath, chest pain. coughing, diffuse headache and some body aches, fever, chills, swea... Read more
Shortness of breath, chest pain. coughing, diffuse headache and some body aches, fever, chills, sweats. increased work of breathing, tachycardic, tachypnic,
64 2021-03-11 chest discomfort chest tightness almost immediately, dizziness; BP 170s/70's. Resolved with hydration and rest in ab... Read more
chest tightness almost immediately, dizziness; BP 170s/70's. Resolved with hydration and rest in about 30 min.
64 2021-03-11 chest pain the day after my shot i had chest pain that felt like my bones needed to pop and the pectoral muscl... Read more
the day after my shot i had chest pain that felt like my bones needed to pop and the pectoral muscles were extremely sore and had a hard time lifting both arms due to the pain. Took tylenol and it did not help at all. The intense pain lasted that day and did ease up somewhat the following day but was still sore with a dull achy pain, and today is the 3rd day and still just a little sore in the chest area
64 2021-03-12 heart rate increased Rapid heart rate that is not letting up
64 2021-03-12 palpitations When driving home following 15 minute wait period I felt my throat tighten, ears flush and heart rat... Read more
When driving home following 15 minute wait period I felt my throat tighten, ears flush and heart rate increasing. I immediately began to monitor my heart rate with my Watch. My resting heart rate is in the 60?s. At the time I looked at the watch my heart rate was already in the low 100?s but was rapidly escalating until in a matter of a few minutes had reached 140 bpm and my head began to have a full sensation and I was becoming very shaky. I pulled over into the parking lot of a restaurant and asked them to call 911. As they were talking with the dispatch my pulse started to decline so I cancelled the request. I stayed at the restaurant until friends to could come pick me up. By the time they arrived my pulse was in the low 100?s. I took 2 Benadryl. I monitored my BP through the night and it did not return to the 60?s until 1:00 am. I took (2) 25 mg Benadryl at approximately 4:00 pm, took another 2 at around 9:00 pm when my heart rate started to escalate and then a final 2 before going to bed at 1:00 am. My pulse dropped back into the 60?s while I was sleeping and stayed that way through the night. I woke up with no further symptoms nor side effects from the shot. The throat tightness and flushing of the ears resolved after the first dose of Benadryl. I had no adverse reactions or significant side effects from he first dose of Pfizer.
64 2021-03-12 palpitations Within 5 minutes of injection my eyes begin burning, my head started swimming and I could not focus ... Read more
Within 5 minutes of injection my eyes begin burning, my head started swimming and I could not focus my vision ,my heart was racing. I had no breathing issues and was able to get through it as it only lasted 6 to 7 minutes. But I'm very concerned as to taking the second dose? Please advise as to getting second dose
64 2021-03-14 pallor, chest discomfort 1318: Received 2nd Covid Vaccine 1330: Pt c/o chest tightness & throat swelling but had similar reac... Read more
1318: Received 2nd Covid Vaccine 1330: Pt c/o chest tightness & throat swelling but had similar reaction w/1st vaccine so took own pre-med and began own nebulizer tx immediately following administration of 2nd vaccine. Chest tightness and throat swelling not as bad as after 1st vaccine. Denies need for Epi pen or Benadryl 1333: BP 124/80 HR 78 RR 18 SpO2 100% NAD, voice sl hoarse, lungs CTAB, cardiac RRR, skin pale, warm, dry, no rash 1338: HR 76 RR 18 SpO2 99% 1340: Released home
64 2021-03-14 pallor, fainting 3-9-21 4:50PM SYNCOPAL EPISODE APROX 2 MIN. PT LOWERED TO FLOOR, LEGS ELEVATED- PT BECAME ALERT. PAL... Read more
3-9-21 4:50PM SYNCOPAL EPISODE APROX 2 MIN. PT LOWERED TO FLOOR, LEGS ELEVATED- PT BECAME ALERT. PALE W/D, NO SOB, NO NAUSEA, NO PAIN. STATES SHE 'ALWAYS PASSES OUT WITH SHOTS'. 4:55PMP SAT PT UPRIGHT FOR 2-3MIN THEN PLACED ON WHEELCHAIR - TOLERATED WELL. GIVEN JUICE AND CRACKERS. CALLED FRIEND TO COME DRIVE HER HOME. 4:17 'FEELS BETTER'. TO EXIT PER W/C TO BE TAKEN HOME PER FRIEND. A/O, PINK, W/D, RESP REG EASE.
64 2021-03-14 chest pain, hypertension, blood glucose increased 3-9-21 6:40PM 'SHARP PAIN IN CHEST X2MIN'. 'ALSO NAUSEA AND FEELS DRUNK'. NO SOB/DYSPNEA. 7:16PM P... Read more
3-9-21 6:40PM 'SHARP PAIN IN CHEST X2MIN'. 'ALSO NAUSEA AND FEELS DRUNK'. NO SOB/DYSPNEA. 7:16PM PLACED IN W/C TAKEN TO MEDIC TENT & PLAACED ON CARDIAC MONITOR: NSR NOTED. 7:25PM STATES 'DECREASED NAUSE AND NO CHEST APIN NOW - STILL FEELS DRUNK'. PT DECLINES JUICE AND CRACKERS - STATES SHE WANTS TO WAIT AND TAKE HER DIABETIC MEDS BEFORE SHE EATS'. 7:30PM 'FEELING BETTER' TO EXIT PER W/C TO BE DRIVEN HOME PER DAUGHTER. 3-12-21 1PM TC: STATES 'NO CHEST PAIN , STILL HAS A LITTLE NAUSEA'.
64 2021-03-14 ischaemic stroke On 2/16/21 I suffered an occlusive stroke. No health problems. No prescriptions meds. BP was always ... Read more
On 2/16/21 I suffered an occlusive stroke. No health problems. No prescriptions meds. BP was always around 120/70's. Height: 5'4", Weight: 126 lbs. All blood work within normal range No high chlolestrol, etc. I was scheduled for 2nd vaccine on 3/1, I was advised to reschedule, which I did for 3/23. I spoke to a coule of health care professionals and asked them if they would proceed with the 2nd vaccine if it were them and was told "no". I am very afraid to get the 2nd vaccine. I would like to discuss this with someone.
64 2021-03-14 blood pressure increased, palpitations Pt received vaccine and began to feel her heart racing about 6 minutes later. She has a history of ... Read more
Pt received vaccine and began to feel her heart racing about 6 minutes later. She has a history of tachycardia with hypertension. She has a cardiologist and a PCP but she has never been prescribed medications for the events because they usually self resolve. BP is 170-190s/110-120s with HR 130-140s most of the time. Pt is on Emstat's monitor. HR improves to 120s, then returns to 140s. Pt remains elevated. Pt elects to be transported to ER for further evaluation via Emstat.
64 2021-03-14 palpitations The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink. Dizzy. Couldn't... Read more
The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink. Dizzy. Couldn't barely lift legs to walk. No bladder control. Hard to get to bathroom. Fell twice. Second time hitting head. Then, Difficulty breathing. And heart racing. (Please note: I did actually have Covid last summer from July through August).
64 2021-03-14 loss of consciousness dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhe... Read more
dehydration; slight fever (99); chills; passed out in floor; sweating; Broke a tooth; Dizzy; Diarrhea; Super tired and went to bed by 8pm after COVID-19 vaccine; Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. Patient did not have known allergies. Patient did not receive any other vaccine the same day and in four weeks. Patient did not have COVID-19 prior to vaccination. The patient experienced passed out in floor (medically significant) on 24Feb2021 at 10:30 PM, diarrhea (disability) on 24Feb2021, broke a tooth (medically significant) on 24Feb2021 at 10:30 PM, dehydration (disability) on 25Feb2021 12:00 AM, slight fever (99) (disability) on 25Feb2021 at 12:00 AM, chills (disability) on 24Feb2021 at 10:30 PM, super tired and went to bed by 08:00 PM after COVID-19 vaccine (non-serious) on 24Feb2021, arm was sore (non-serious) on 24Feb2021, sweating (non-serious) on 24Feb2021 at 10:30 PM, dizzy (non-serious) on 24Feb2021. No therapeutic measures were taken as a result of the events. Patient stated that all side effects resolved completely by 25Feb2021 evening, except for broke a tooth. Patient did not tested positive for COVID-19 post vaccination. The information on the Lot/Batch number has been requested.
64 2021-03-15 cerebrovascular accident Beginning February 28, 2021 stroke, seizure, fever, headache and weakness.
64 2021-03-15 blood pressure fluctuation Tingling, feeling faint, itchy tongue, light headed, blood pressure checks: 09:43am 150/75, 09:45am... Read more
Tingling, feeling faint, itchy tongue, light headed, blood pressure checks: 09:43am 150/75, 09:45am 100/70 Epipen administered. Blood pressure at 09:48am 130/82 Transported at 09:57
64 2021-03-16 chest pain, palpitations, hypertension With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rash... Read more
With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rashy red and hot, had the shakes, nauseous dizzy and short of breath, blood pressure was high, with in hour my heart rate started to slow down, I took a Benadryl, felt ill. Tuesday started having diarrhea then around 11:30 pm had same reactions as Monday after shot was given. Took another Benadryl. Wednesday still bouts of diarrhea, tired,weak.nauseous.
64 2021-03-17 palpitations 1. Heart palpatations - didn't last long - seemed to subside after I drank water and did deep breat... Read more
1. Heart palpatations - didn't last long - seemed to subside after I drank water and did deep breathing 2. Woke next morning with pain between my shoulder blades - didn't last long either once I was up and moving
64 2021-03-17 fast heart rate After leaving the parking lot of the church, I started to feel dizzy, having hotflashes, weak, and I... Read more
After leaving the parking lot of the church, I started to feel dizzy, having hotflashes, weak, and I was experiencing fast heartbeat. I pulled over the car, and then I was shacking. I opened the window to get some fresh air, and drunk water. I could not moved or do anything. I waited in my car for over 20 minutes hoping that I would feel better. I was still feeling weak and shacking. Finally a member of my family came to pick me up. and took me back to the church which was less than one mile. I explained the situation, they told me that they did not have a doctor on premise and to contact my primary care physician or to go to an emergency care facility. I started to shack less. So the member of my family took me back home and I just relaxed while I had chills for two hours.
64 2021-03-17 pulmonary embolism, deep vein blood clot Severe, bilateral pulmonary emboli and 3 DVTs in left leg
64 2021-03-17 chest discomfort, hypertension Within 15-minutes of vaccination, the patient reported chest tightness and was concerned she was hav... Read more
Within 15-minutes of vaccination, the patient reported chest tightness and was concerned she was having an asthma attack. EMS evaluated the patient on-site. The patient was hypertensive (150/85). The patient's EKG demonstrated NSR, rate 82bpm, no ST elevations. EMS administered 8L/min O2 and DuoNeb (2.5mgAlbuterol/0.5mgIpratoprium). EMS transported the patient to Emergency Department. In the ED, the patient reported general weakness and feeling mildly lightheaded in orthostatic position. The patient noted feeling better after taking their inhaler and receiving the DuoNeb treatment. Labs were non-actionable. The physician administered 1L normal saline and discharged the patient with diagnoses of Chest tightness, Adverse reaction to vaccine, Asthma, Orthostatic Lightheadedness. Patient was prescribed Albuterol Sulfate on discharge.
64 2021-03-17 blood pressure increased patient stated she felt like her blood pressure was going up right after vaccine administration. I t... Read more
patient stated she felt like her blood pressure was going up right after vaccine administration. I took her BP and it was 190/112. She got hot and then cold and shaky. I got her some water and propped her feet up and took her blood pressure 3 or 4 more times over about 20 minutes then we decided to call 911.
64 2021-03-18 heart rate irregular, chest discomfort Experienced fullness in the chest that I initially attributed to bronchial or epigastric irritation,... Read more
Experienced fullness in the chest that I initially attributed to bronchial or epigastric irritation, then I realized I was having irregular heart beats and a feeling of 'heart irritation'. I have a stethoscope so I listed to my heart and was able to identify 4-10 irregularities / minute intermittently for the next 10 days. At times this was symptomatic with a feeling of irritation or congestion in my chest that would reduce with a cough. I am a runner and symptoms did not increase with exercise and when I started watching closely they decreased with walking , slow running or my weigh lifting. Symptoms are receding, on occasion, I feel an irritation in my chest but heart irregularities are subsiding.
64 2021-03-18 chest discomfort Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later i... Read more
Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later it spread to back of the neck and went up through the scalp at the back of the head to the crown of the head. Headache the whole time. Face returned to normal in 90 minutes. Scalp in 2 1/2 hours. Muscles aches starting in left arm, moved to left leg and then to right leg. Headache is persistent but mild 4 hours later.
64 2021-03-18 oxygen saturation decreased For two days following the vaccine (March 6 & 7) I experienced severe body aches, fever, chills, fat... Read more
For two days following the vaccine (March 6 & 7) I experienced severe body aches, fever, chills, fatigue. Horrible shortness of breath began on the third day, March 8, and continued to worsen. For the next week my breathing became more and more labored with difficulty in functioning and needing to be in a reclining position in order to breathe. By the 10th day, o n March 15th I was hospitalized and subsequently had tests run on heart and lungs. My blood oxygen would drop to the low 80's if I took just a few steps. Today, on March 19th I am home and slowly improving but still needing to be mostly resting.
64 2021-03-18 chest pain Patient complained of feeling hot and diaphoretic and then complained of chest pain and some shortne... Read more
Patient complained of feeling hot and diaphoretic and then complained of chest pain and some shortness of air
64 2021-03-18 chest pain Reports to ED 2 days after first Pfizer vaccine with SOB, chest pain, headache, fatigue. Normal EKG ... Read more
Reports to ED 2 days after first Pfizer vaccine with SOB, chest pain, headache, fatigue. Normal EKG and troponin, normal D-dimer. Likely normal vaccine reaction. Discharged home in stable condition. 3 days later presents to PCP, still symptomatic and now with tingling all over body and slight numbness to right side of face and arm. No deficits, likely extended vaccine reaction.
64 2021-03-19 palpitations, hypertension About an hour after receiving the vaccine I started getting pins and needles in my face/jaw. About ... Read more
About an hour after receiving the vaccine I started getting pins and needles in my face/jaw. About 2 hours later my blood pressure was high - 150/90 (checked on a home monitoring machine) and then I started with heart palpitations which lasted throughout the night - did not sleep more than an hour or two. Next day around noon had diarrhea a few times - tired and weak. Slight headache for about 4 days. Nausea for about 3 or 4 days.
64 2021-03-19 chest discomfort Pt started coughing and having chest tightness about 10-15 min after receiving her vaccine. She des... Read more
Pt started coughing and having chest tightness about 10-15 min after receiving her vaccine. She described the incident as "like when my asthma acts up". Dr listened to her lungs and administered an albuterol nebulizer treatment. Her O2 sats were between 96-98 and her pulse was 70-80 during the entire incident. She did get relief from the treatment and was breathing better and not coughing after the treatment. She was evaluated by Dr and was allowed to go after 30min with instructions to call 911 if symptoms returned or worsened.
64 2021-03-20 blood glucose increased, blood pressure increased allergic to something in the vaccine; Myoclonic jerking; I felt very hot; I started shaking uncontro... Read more
allergic to something in the vaccine; Myoclonic jerking; I felt very hot; I started shaking uncontrollably.; Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at 16:00 (at the age of 64)(Batch/Lot Number: EN6205) as a single dose for covid-19 immunisation . The vaccination was given at a hospital. There were no other vaccinations given within 4 weeks. The patient was not diagnosed with COVID prior to vaccination. Medical history included breast cancer and an allergy to sulfa drugs. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); levothyroxine, liothyronine (NP THYROID). On 25Feb2021, about 2 hours after the vaccination (18:30) I felt very hot. I was not running a fever. I started shaking uncontrollably. The shaking was not chills. My husband took me to the emergency room. This was their summary. Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar level; Myoclonic jerking; Vaccine reaction I saw my general practitioner the following day and everything was back to normal. I am allergic to something in the vaccine and I am afraid to get the 2nd dose. No treatment was given for the events.The outcome of the events was recovered. The patient was not tested for COVID post vaccination.
64 2021-03-20 heart rate increased, chest discomfort chest pressure 4/10, elevated heart rate, shortness of breath, dizzy/lightheaded, EMS evaluated, pat... Read more
chest pressure 4/10, elevated heart rate, shortness of breath, dizzy/lightheaded, EMS evaluated, patient refused transport
64 2021-03-20 chest discomfort itching all over difficulity in breathing wheezing tightness in chest had to take benadryl for ... Read more
itching all over difficulity in breathing wheezing tightness in chest had to take benadryl for 4 days due to itching
64 2021-03-20 blood pressure decreased, palpitations post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 m... Read more
post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 minutes-slight drop in blood pressure (I've gone as low as 32/18 during a bad reaction so I know this time was a much smaller drop) 13 minutes-stomach pains started, these would continue throughout the night waking me, and lasted approximately 17 hours 30 minutes- sudden feeling of lightness in my body, and that a light had gone on 60 minutes-odd sensations in throat but did not feel swelling, simultaneously at 60 minutes-dizzy the next day, 10 bowel movements until 2 pm
64 2021-03-21 blood pressure increased Sore left arm, chills, monitored my blood pressure. I noticed elevations started to occur after the ... Read more
Sore left arm, chills, monitored my blood pressure. I noticed elevations started to occur after the second dose. I was on Lisinopril before my first dose vaccine my doctor changed my BP medication to Losartan. I was basically allergic to the Lisnopril medication. My doctor increased the dose of the Losartan.
64 2021-03-21 fast heart rate Tachycardia with Dysnomia
64 2021-03-22 blood pressure increased Blood pressure raised to 160/120, a feeling of unwell
64 2021-03-22 chest pain, blood pressure increased Patient received Pfizer vaccine and waited 30 mins as directed. Patient left and ambulated to car. S... Read more
Patient received Pfizer vaccine and waited 30 mins as directed. Patient left and ambulated to car. Started having chest pain with shortness of breath. Patient came back into clinic to inform nurse she was having symptoms. Patient having 4-5/10 chest pain. Initial vitals were BPL 170/94, HR:64, and O2:98% at 1435. Patient observed by nurse with education given about elevated blood pressure. EMS activated and arrived at 1445. Upon arrival, 12 lead EKG done and care transferred to EMS with report given. Daughter notified about mother's condition. SOB went away but chest pain lessened. Taken to Hospital Emergency Dept.
64 2021-03-22 loss of consciousness dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well o... Read more
dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well over 12 hours; stomach pain; big bump on my head where I hit the tile floor; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 05Mar2021, 16:30 as a single dose for covid-19 immunisation. The patient's medical history included allergies to Sulfa based meds from an unknown date and unknown if ongoing. The patient had Covid prior to vaccination. Concomitant medications included cranberry; colecalciferol (D3), fish oil, and multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 05Mar2021 at 18:30, the patient experienced headache, nausea, arm soreness 2 hours after injection. Chills for well over 12 hours. Most concerning, patient got up in the middle of the night. Used facilities. Washed hands, and was having stomach pain. Then she passed out. she came to, and have a big bump on her head where she hit the tile floor. Sunday Morning (07Mar2021) she was dizzy. Maybe from the bump on her head. The patient did not received treatment for the events. The outcome of the events was recovering at the time of the report. The has not tested positive for Covid-19 post vaccination.
64 2021-03-23 blood pressure increased, fainting After 10 minutes of receiving shot I felt a cold surge in my left arm and felt lightheaded. I felt ... Read more
After 10 minutes of receiving shot I felt a cold surge in my left arm and felt lightheaded. I felt sweaty, weak and faint. The EMTs quickly came to my side and administered my blood pressure and oximeter. When I continued to feel lightheaded they took me to a back room and hooked me up to an EKG with electrodes throughout my body. They retook my blood pressure and told me that my blood pressure had risen to 180/90 earlier! After sitting for a while they took it again and read 160/80. They told me to get it checked again, asked if I need go to ER, Walk-in or doctor. They walked me out to my husband, who was waiting in car. I went home and slept for 11/2 hours. Took my blood pressure the next day 3 times and averaged in the low 120s.
64 2021-03-23 fast heart rate After one hour develop severe headchage, extrimly tired, body and muscle pain,chills,feeling unwell,... Read more
After one hour develop severe headchage, extrimly tired, body and muscle pain,chills,feeling unwell,fast heartbeat,join pain
64 2021-03-23 hypertension Light headed, dizzy,neck pain, tiredness, blood pressure high, nausea Thought I was having a heart... Read more
Light headed, dizzy,neck pain, tiredness, blood pressure high, nausea Thought I was having a heart attack.
64 2021-03-23 blood pressure increased Numbness/ tingling in lips and left side of head/face. I returned to Clinic area, had elevated B/P ... Read more
Numbness/ tingling in lips and left side of head/face. I returned to Clinic area, had elevated B/P and took claritin.
64 2021-03-23 chest discomfort Tingling in lower extremities (mostly below knee) bilaterally within first 5 minutes or so. Followe... Read more
Tingling in lower extremities (mostly below knee) bilaterally within first 5 minutes or so. Followed by tingling tip of tongue and portion of lower lip tingling. Itchy/tingly sensation back of throat on right with very slight hoarseness and slight chest tightness. Also noted some ectopy on my Kardia monitor--looked like PACs, but lots of interference in the reading. Symptoms not severe enough to use albuterol inhaler. By two hours, they had completely abated. Primary care doctor notified on 3/24/21 for counseling as to future immunization plan.
64 2021-03-24 deep vein blood clot DVT day after vaccination
64 2021-03-24 chest discomfort Patient stated she felt some chest heaviness and some mild shortness of breath 5 minutes after recei... Read more
Patient stated she felt some chest heaviness and some mild shortness of breath 5 minutes after receiving her vaccine. She also claimed she was light headed and had a wave of nausea right after her vaccine. She said she has never had a vaccine reaction like this before and claims she ate breakfast this morning. Upon our interview, her symptoms decreased. She denied any swelling, trouble speaking, drooling. We added 10 minutes on to her observation time and after that she was ready to go. When pt left, she did not have any chest tightness or SOB.
64 2021-03-24 loss of consciousness Pt passed out briefly about 7 minutes after vaccine was administered. I followed company`s protocol... Read more
Pt passed out briefly about 7 minutes after vaccine was administered. I followed company`s protocol and she was okay after about 2 to 5 minutes. Paramedics came but she refused going to ER with them because she was already feeling better by the time they arrived
64 2021-03-25 platelet count decreased, low blood platelet count 1st COVID vaccine 2/10/2021 . Dx with COVID 2/17/2021. 2nd dose COVID vaccine 3/22/2021. On 3/24/2... Read more
1st COVID vaccine 2/10/2021 . Dx with COVID 2/17/2021. 2nd dose COVID vaccine 3/22/2021. On 3/24/2021 developed petechial rash. On 3/25/2021 presented to ER for evaluation. Platelet count 4,000. Patient admitted to hospital with ITP. Started on IV steroid and given platelet transfusion.
64 2021-03-25 blood pressure fluctuation Patient had a really bad headache first and thought she was going to pass out several times for a fe... Read more
Patient had a really bad headache first and thought she was going to pass out several times for a few days after the dose. It also made patient wheeze for 3-4 days, and then starting the second week until now her blood pressure is continuing to be out of control even after her doctor doubled her dose of bp meds.
64 2021-03-25 heart rate increased Pfizer -BioNTech COVID-19Vaccine EUA About 10 minutes after having the shot, I had a rush to my hea... Read more
Pfizer -BioNTech COVID-19Vaccine EUA About 10 minutes after having the shot, I had a rush to my head and a feeling of being faint, followed by a rapid heartbeat. This subsided after a few minutes, but the rapid heartbeat seemed to remain for hours. It felt like a low blood sugar attack. I had not eaten a proper breakfast before having this shot and I am wondering if that had something to do with it. I want to make sure I can have the second shot if I eat well before I go and have hydration with me. I waited an extra 10 minutes and got out to my car and ate some nuts and drank water. Felt like I had too much caffeine the rest of the day.
64 2021-03-25 hypertension, fast heart rate Tachycardia body was on fire high bp shaking Nausea feeling of impending doom headache
64 2021-03-25 heart rate increased, heart rate irregular dizziness/ light headedness; rapid heart rate at 130; irregular heartbeat; This is a spontaneous rep... Read more
dizziness/ light headedness; rapid heart rate at 130; irregular heartbeat; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Feb2021 11:00 (Batch/Lot Number: EL9265) as single dose for covid-19 immunisation. The patient was not pregnant. Medical history included irregular heart beat, controlled hypertension, high chloresterol. Known allergies included sertraline hydrochloride (ZOLOFT). There was no covid prior vaccination. No covid tested post vaccination. There was no other vaccine in four weeks. Other medications in two weeks included ezetimibe taken for an unspecified indication, start and stop date were not reported; duloxetine taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported and cholesterol medications. The patient had light headedness, dizziness, rapid heart rate at 130, irregular heartbeat; on 20Feb2021 11:30 AM. The patient went to hospital on the 2nd day after vaccine. Events resulted in Emergency room/department or urgent care. Treatment received for the events included fluids and meclizine 25 mg. The outcome of the events was recovering.
64 2021-03-26 hypotension, palpitations, heart rate decreased, heart rate increased, hypertension 6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 ... Read more
6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 1/2 full days . tingling of hairline and under the eyes, eyes were blurry for two days, starting getting heart palpatations, and blood pressure high and resting heart rate low and other times blood pressure was real low and resting heart rate as high as 125 even at rest not due to exercise... this continued with the heart irregularaties for abour two weeks. . i experienced unusal forgetfulness and couldnt recall things I knew .. i had mild fatigue... 3 weeks later Im about 90 percent but a little sluggish. finally was able to do yoga(bending over ) weights,,walking,etc.
64 2021-03-31 heart flutter, palpitations At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt a... Read more
At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt as if my heart was vibrating. I am sure later I had a TIA. Was unable to communicate. I knew what I wanted to say but I could not get the words out. March 1/2021 I went on FLMA. It never dawned on me the vaccine could have affected my already stressed heart. I am still experiencing these symptoms. I just thought of this this week. I still have extreme fatigue, increased palpitations, and increased SOB. I do not feel able to work right now.
64 2021-03-31 deep vein blood clot Deep vein Thrombosis cot, followed 2 days later by multiple blood clots in her lungs.
64 2021-03-31 chest pain Dizziness, shortness of breath, chest pain
64 2021-03-31 loss of consciousness Passed out at the casino and transported to Hospital b y Ambulance. I Was kept overnight. Feeling ... Read more
Passed out at the casino and transported to Hospital b y Ambulance. I Was kept overnight. Feeling light headed , dizzy and hot. . 1 day after the second doze of the pfizer shot. Passed out approximately 15 minutes after filling the symptoms.
64 2021-03-31 deep vein blood clot acute left leg pain and swelling 15 hour after vaccination with subsequent same day ER visit and ult... Read more
acute left leg pain and swelling 15 hour after vaccination with subsequent same day ER visit and ultrasound diagnosis of acute left leg DVT (blood clot) diagnosed.
64 2021-04-01 loss of consciousness She said that she has a pretty swollen black eye that is really red too; She said that she has a pre... Read more
She said that she has a pretty swollen black eye that is really red too; She said that she has a pretty swollen black eye that is really red too; She said that she has a pretty swollen black eye that is really red too; Blacked out; severe stomach cramps; Nausea; Diarrhea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Mar2021 at 09:55 (Lot Number: ER2613, unknown expiration) as a single dose for COVID-19 vaccination. Medical history and concomitant medications reported as none. The patient received the first shot of COVID-19 vaccine in the morning of 18Mar2021, and after supper, she experienced severe stomach cramps, nausea, diarrhea, vomiting, and stated that she blacked out. She mentioned that she is just taking it slow and eating broth. She confirmed that blacking out has only happened to her 2 other times in her life. She said that it usually happens with the cramping and the vomiting in this same kind of situation. She plans to follow up with the physician. She said that she has a pretty swollen black eye that is really red too (unspecified date). She is putting ice on it. It did not seem like she ate anything that would cause this reaction. She has no other reason to think her reaction could have been caused by anything else. She called the pharmacist and they told her to report it to Pfizer. No additional vaccines administered on the same date of COVID-19 vaccine. No prior vaccinations within 4 weeks. The patient recovered from events blacked out, severe stomach cramps, diarrhea, and vomiting on 18Mar2021; recovering from nausea; while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
64 2021-04-02 palpitations Heart palpitations; This is a spontaneous report from a contactable consumer. A 64-year-old non preg... Read more
Heart palpitations; This is a spontaneous report from a contactable consumer. A 64-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Formulation: solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration in arm right on 8Feb2021 at 19:00 as single dose for covid-19 immunisation. Medical history included diabetes mellitus, palpitations, hyperlipidaemia and diverticulum. Concomitant medications included metformin, aspirin [acetylsalicylic acid] (Aspirin [Acetylsalicylic Acid]), atorvastatin, diltiazem and cinnamomum verum (Cinnamon). Patient did not receive other vaccine in four weeks.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 08Feb2021 at 20:00, heart palpitations but I get those frequently. The outcome of the event was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.
64 2021-04-02 heart rate abnormal, lightheadedness, chest discomfort headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad press... Read more
headache; dizziness; chest was tight; was not breathing very well for 3- 4 days; wheezing; bad pressure in the back of her head; felt like her heart was skipping beats; heart rate and blood pressure seem to be very erratic; erratic heartrate; arm swelled up and was sore; arm swelled up and was sore; lump in throat; unwell feeling all over like she was going to pass out.; unwell feeling all over like she was going to pass out.; She kept getting an icky feeling; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [26Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from contactable consumers (one is patient). A 64-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot Number: EN6204), intramuscular, administered in right arm on 08Mar2021 14:10 (at the age of 64-year-old) at single dose for Covid-19 immunization. Medical history included high cholesterol, osteoporosis, high blood pressure, arthritis, stenosis of neck and spine, allergies to dust and cleaners (when she cleans, the bottom of her neck swells up huge); all were ongoing. She has very high cholesterol, she believes it was close to 400 the last time it was checked and that's why she was given Repatha which brought it way down, but she doesn't know if she can take the Repatha again. She also has quite a few allergies - allergic to cats, sulfa, grass and Pre-diabetes. She has a fair amount of allergies. Her doctor thinks she has some asthma because she has had a little trouble breathing at different times, but she doesn't have an inhaler or anything. She mentions asthma and allergies run in her family. The patient also stated that a majority of her life, has had low blood pressure until about 9 years ago when her father passed. States that her blood pressure had been out of control for 6 months and was then put on a low dose of Carvedilol, and eventually evened out. Concomitant medications included ongoing carvedilol taken for blood pressure; ongoing loratadine (CLARITIN) taken for allergies from 1996 (has been taking for 25 years); ongoing lansoprazole taken for acid reflux; ongoing rosuvastatin calcium taken for cholesterol since Sep2020; ongoing calcium; carvedilol (COREG) taken for blood pressure. The patient had a previous reaction to a cholesterol medication evolocumab (REPATHA) from 23Oct2020 to 23Oct2020 - her neck swelled up pretty big and she had hives on her chest, which ended up going away. Therefore, she doesn't know if she can take that again or not. The patient also previously took rosuvastatin calcium (CRESTOR) 5-6 months ago and it made her legs ache really bad; esomeprazole sodium (NEXIUM) and had the problem; lansoprazole (PREVACID) for acid reflux. She took Nexium which was a different product with different ingredients and her blood pressure was still high the whole day. States that her doctor had prescribed another brand, which had the same main ingredient as the Nexium, and told her to double up on it one night, so she did that and about an hour later she just about hit the floor because her blood pressure shot up to about 200 over 100 and something, so she talked to the pharmacist who said that this was not a normal reaction to the ingredients in Nexium, but it happened to her every time she took it. She had been taking Prevacid for a long time but then started to get an allergic reaction. Clarified that feeling like she was having an allergic reaction after taking the Prevacid at night, was something that she has just started noticing within the last month. Wondering if the 2nd dose of the Prevacid is too much. States that she still takes this in the morning but not in the evening. States that she has started taking 15mg at night from an over the counter version of the same medicine (Lansoprazole). She explained that she hasn't had any vaccines as an adult, she never has had a flu shot. About 5 years ago, she had a bat in the house for 3 days and the bat ended up hitting her in the head and forehead as they were trying to get the bat out of the house, so she ended up getting a rabies vaccine. She was wondering and hoping there were no interactions with that. With the rabies vaccine, she did have a headache. She had to get 4 or 5 shots and she did not feel well most of the time. It took a long time to pass for her to feel normal again. The caller received the first dose of the vaccine last Monday on 08Mar2021, after the shot and while waiting those 30 minutes, she felt a lump in her throat which lasted all day and the next day, but it went away. She confirms by 10Mar2021, she recovered completely. Her arm swelled up and was sore for a day and half on 08Mar2021, but that went away. She isn't worried about that. She also has a really bad headache and was very dizzy on unspecified dates. She is concerned about the dizziness. She has been driving, but about the second day after getting the vaccine, she was leaning over talking to her mom and she felt like she going to pass out. She didn't, but she felt like she was. She has been using hot packs. It's like she has a headache around her temples and the back of her head seems to be hurting. In fact, she put a hot pack there while waiting to speak to this call handler. She doesn't know if its tension or what. She didn't have hives or none of that from COVID vaccine which she was excited about, but she is so dizzy she can hardly stand. She can't get rid of the headache and dizziness. She wants to know whether or not to go ahead with the next vaccination. This is the 5th day of having this dizziness. She was thinking the dizziness was going to last for a couple of days, but its going on 5 days. Even just sitting, She states it's kind of scaring her. She was thinking it would just go away, but it isn't. Her heart rate and blood pressure seemed to be very erratic on 12Mar2021. She woke up this morning (12Mar2021) and her blood pressure was very high, but she checked it within a few minutes and was dropping low. Her heart goes fast and then slows down, but she has had problems with this in the past. The dizziness has been bothering her a lot, she has been afraid to drive. The patient had a blood pressure of 150/102 on unspecified date. On 17Mar2021, She mentioned she will see her HCP at 2:00 PM. She has already filed a report regarding the side effects she had. She filed a report and asked if she should get the second dose shot. However, she was informed if her HCP called, they may be able to provide her with more information. She was informed her HCP could call the medical line. On 26Mar2021, she stated that the first report was filed the first week and that during the second week, more not good things have been happening. She wrote down the report number from the first report but does not have it now. Since the vaccine, she has been having different symptoms; she is not sure if it is related to the vaccine but wanted to report it. She was a little concerned because she has allergies, stating she had just tried an injectable cholesterol drug and she did break out hives and her neck had swelled. States that she has not had any vaccines as an adult, so she was a little bit cautious anyway. She clarified that she did not have hives and did not have any breathing problems when she left. Stated that later that evening and the next day had a really bad headache and bad pressure in the back of her head, which she knew was typical. States that 3 or four times she felt a rush over her body and felt like she was going to pass out. That night and the next day (unspecified date), she was having breathing problems (was not breathing very well for 3- 4 days) and her chest was tight and she was starting to wheeze, and continued for about 3 or 4 days. She kept getting an icky feeling Monday and Friday when she got up and had unwell feeling all over like she was going to pass out on unspecified date in Mar2021. States she had real bad pressure in her head and high blood pressure and felt like her heart was skipping beats on unspecified date. States her blood pressure was around 152/100 on 09Mar2021. One-day blood pressure was real low, 88 over something but that kind of went away. States all that information was already reported. The next week, she thought she was feeling better and that Monday and Tuesday felt back to normal. Stated that on Thursday night (Mar2021), she was just sitting and around 8 o'clock her blood pressure spiked within a few minutes to around 184/105 and she wasn't doing anything; she couldn't get it to go down. States that she went to the ER to check everything out last Thursday. Every night since then, somewhere around 8 o'clock, her blood pressure spikes really high. Stated she then called her doctor. Stated she was on a really low dose of blood pressure medication, stating that she had occasional problems with her blood pressure in the past but it never went that high. Her blood pressure was usually in the 140's or 150's over 90 something. States that now it is much higher and happening every night. Caller stated that Wednesday night (24Mar2021) her blood pressure started to spike every 5 to 6 hours, stating it first started at 830 at night and again at 230 in the morning. She has been feeling unwell since that shot. Her doctor thinks it may be causing inflammation. States that they doubled her medication last night and her blood pressure is still going up and up, but usually goes down after a couple of hours. It is totally uncontrolled and her doctors are trying to figure it out. States that meds have been added, including Xanax and will be going to see a heart doctor. States that this has all been since the vaccine. Caller would like to know if people are reporting these symptoms. States that it is pretty terrible, and that she feels normal and then it rushes over her. States that it is exhausting and that she almost went to the ER last night. States that she does not want to go back if she does not have to. When she filed the first report she did not have issues with blood pressure yet. Again, she had the vaccine on Monday 08Mar2021 and that the next Thursday she felt like her heart rate was really high. During that first week, she felt out of rhythm, like missing beats. Her blood pressure dropped low the first week and that just one time was around 152/100 but it didn't sustain. It then dropped pretty low one day. The next Thursday, it was uncontrollable. It was around 180 over 104 or 105 and that it kept going up, but then back down to 160/90 something. Took Xanax and went to bed, when she woke up this morning it was low, but went right back up within 5 minutes. In the first couple of days, they increased her blood pressure medicine and it seemed to be bringing her blood pressure down and she was able to go to bed. The caller stated that Monday, it will be three weeks. States that a day and a half after the vaccine, her arm was not hurting but was still puffy, but not bad. States that when she runs her hands over it, it is still sore to the touch and a little swollen but nothing extreme. She was concerned that her blood pressure keeps going up and then down. States that the blood pressure started spiking on the 18Mar2021, in the evening very quickly and was very high. Stated that this was happening every night since then until the 24th, when it started spiking every 5-6 hours; and her blood pressure medicine wasn't controlling it like it was earlier in the week, even though the dose was doubled. For one day it worked good and brought it down low but then, it wasn't controlling it anymore. She stated no relevant tests, related to this event but states that in her last 2 labs her cholesterol was high. States that it was over 300 and her bad cholesterol double or more triple. States this has been going on for many years. States that she changed her calcium to calcium with vitamin D and her vitamin has come back up. When she was in the ER they did a Metabolic panel and everything looked okay. The adverse events require and emergency room visit. The patient recovered from the event lump in throat on 10Mar2021; the events arm swelled up and was sore recovered in Mar2021; the events erratic heart rate, chest was tight, was not breathing very well for 3- 4 days, wheezing resolved on unspecified date. The outcome of dizziness, blood pressure seem to be very erratic was not recovered and the outcome of the remaining events was unknown.
64 2021-04-06 platelet count decreased, low blood platelet count I got the shot on 3/22 and on 3/25 I was hospitalized for a flare-up of ITP with a platelet count of... Read more
I got the shot on 3/22 and on 3/25 I was hospitalized for a flare-up of ITP with a platelet count of 14. Got 2 units each of dexamethazone, IVIG, and platelets. Released on 3/27 with a count of 161. Readmitted 4/5 with a count of 11. One round of platelets, count fell to 8 in 24 hours. Then I got 1 round of IVIG, count raised to 10 in 24 hours, which was this morning. Advised not to get 2nd shot.
64 2021-04-06 skin turning blue Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling... Read more
Within 45 secs to 2 mins of receiving the Pfizer vaccine #1, patient (myself) experienced tingling in Lt, eye then swelling in Lt. eye lids, lt. cheek, lt. corner mouth which progressed. This was witnessed by the team giving vaccine and later on by EMT on the scene. Post feeling dizzy along with swelling the EMT person had me leave my car & placed me on litter in ambulance waiting in parking lot. Within 5 -6 mins. of the shot, I then felt severe HA, and swelling in my throat. EMT immediately started IV - gave IV Benadryl, then gave 1 shot of Epinephrine. Called EMT which took me via ambulance to hospital. There EM MD assess then gave me Solumedrol IV push & admitted me to ED OBS formally. Felt better but then few hours later all symptoms returned along with severe pain in hand with red palms & cyanotic finger tips. ED MD treated me again with higher dose of Benadryl & add Prilosec for potentiation of Benadryl and observed me. Felt better after several more hours. Was discharged on 50 mg Prednisone X 5 days & prescription for Epinephrine pen. Followed up w/PCP couple days later.
64 2021-04-07 chest pain, pulmonary embolism Two weeks after receiving the vaccine I went to the ER with excruciating pain in my chest. Was diag... Read more
Two weeks after receiving the vaccine I went to the ER with excruciating pain in my chest. Was diagnosed with a pulmonary embolism. My son who is 33 yes old had the same result after his first Pfizer vaccine in the exact same time frame - yesterday.
64 2021-04-07 ischemic chest pain pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and ... Read more
pain in the heart; semi-hallucinatory dreams; 3 day duration: extreme headache; fatigue; nausea and vomiting; nausea and vomiting; diarrhea; chills; cold sweats; fever spiking to 103.9 F; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), via an unspecified route of administration, at the age of 64 years, administered on the left arm on 21Mar2021 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included atypical homozygous pseudocholinesterese deficiency from an unknown date and unknown if ongoing. Concomitant medications included liothyronine (LIOTHYRONINE) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6203) on 02Mar2021 09:00 AM on the left arm for COVID-19 immunization. On 21Mar2021 18:00, the patient experienced 3 day duration of extreme headache, fatigue, nausea, vomiting, diarrhea, chills, cold sweats, fever spiking to 103.9 F, pain in the heart and semi-hallucinatory dreams. The patient underwent lab tests and procedures which included body temperature: 103.9 fahrenheit on 21Mar2021. Treatment was not received for the events. The outcome of the events was recovering. Additional information has been requested.
64 2021-04-08 fast heart rate, platelet count decreased Pt received the shot on Thurs 4/1/21. This is a 64-year-old patient who presents with 1-1/2 days of ... Read more
Pt received the shot on Thurs 4/1/21. This is a 64-year-old patient who presents with 1-1/2 days of body aches, fevers, tachycardia, fatigue and does not have any exposure to COVID-19 but she just got on Thursday her first shot of her vaccination she also has vomiting and malaise. TTP rash started on 4/7/21.
64 2021-04-09 atrial fibrillation I developed weak, rapid, irregular heartbeat indicative of atrial fibrillation; This is a spontaneou... Read more
I developed weak, rapid, irregular heartbeat indicative of atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot Number: ER2613) via an unspecified route of administration in left arm on 19Mar2021 at 11:00 am (at the age of 64-year-old) for COVID-19 immunisation. Medical history included persistent atrial fibrillation, allergies to sulfa. Patient was not pregnant at the time of vaccination. Heart in regular sinus rhythm for several months prior to vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included dofetilide (TIKOSYN) 250mcgtwice daily, loratadine and ibuprofen, (all received within 2 weeks of vaccination). The patient previously took dofetilide (TIKOSYN) for atrial fibrillation (persistent atrial fibrillation was controlled with 250mcg twice daily); also took erythromycin and had allergies. Patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 17:15, the patient developed weak, rapid, irregular heartbeat indicative of atrial fibrillation. This last 8 hours. The patient did not receive any treatment for the events. Patient noted regular heartbeat on 21Mar2021 at 1:15am. Patient visited to physician office for events. The outcome for the event was recovered on 21Mar2021 at 1:15am. Follow up attempts needed. Further information is expected.
64 2021-04-09 loss of consciousness feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain... Read more
feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved. She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered. Information on the lot/batch number has been requested.
64 2021-04-09 blood pressure decreased horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; horrible hives... Read more
horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; she was a little bit red; blood pressure lowered a little bit; This is a spontaneous report from a Pfizer sponsored Program . A contactable Physician reported for herself that. A 65-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 14Feb2021 15:00 (Batch/Lot Number: FL9267) as SINGLE DOSE for covid-19 immunisation (Age at vaccination was 64 years). Medical history included immunocompromised and she is a very allergic person and can treat allergies. Concomitant medications were not reported. On an unspecified date patient experienced horrible hives and hoarseness and itching, she was a little bit red and blood pressure lowered a little bit. It was reported that after the 1st dose of the Pfizer COVID Vaccine, it seems like she was a little bit red and she did not pay much attention to it then at night on the 2nd day and that night became horrible hives and hoarseness and itching; caller states these symptoms are not ongoing and lasted about 4-5 days; states the 2nd day the hives started at night about 24 hours over. Caller states then the symptoms disappeared and she used an antihistamine Benadryl and every time she takes it is 50mg and she then used Zyrtec 10mg and only used the Zyrtec twice and had terrible side effects from the Zyrtec and did not like it and prefers the Benadryl; no further details provided by the caller. Caller states because she was an allergic subject, she always has Benadryl at home. the first night after she had the Pfizer Covid vaccine, she had her epipen with her but was following her blood pressure and pulse and the blood pressure lowered a little bit but not terribly and the pulse was the maximum of 99 so she decided not to go to the emergency room and she stayed home and did not do the epipen; states she decided to stay home and monitor herself but she was ready to go to the emergency room if needed and by 9:00pm she seemed fine and only her blood pressure had slowed a little bit and her pulse at one time went to 99 and she did not do the epipen; despite further attempts at clarification, the information is captured as stated by the caller. Caller states the 2nd dose (lot number EN6204) was administered on 13Mar2021 around 12:00pm. The patient underwent lab tests and procedures which included blood pressure measurement: lowered a little bit, heart rate: maximum of 99 on, sars-cov-2 antibody test: negative on 29Mar2021. Reporter seriousness for antibody test that was done came back negative was Medically significant. Outcome of the events was recovered on unspecified date.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
64 2021-04-11 chest discomfort Received second shot in left deltoid 4/3, mylagia 4/4, nausea 4/5, chest pressure and shortness of b... Read more
Received second shot in left deltoid 4/3, mylagia 4/4, nausea 4/5, chest pressure and shortness of breath started 4/6
64 2021-04-14 blood clot, cerebrovascular accident blood clotting in legs, lungs, resulting in hospitalization. Second clotting event resulting in stro... Read more
blood clotting in legs, lungs, resulting in hospitalization. Second clotting event resulting in stroke and hospitalization, ongoing treatment and evaluation
64 2021-04-16 pulmonary embolism, deep vein blood clot DVT left leg and bilateral pulmonary embolism (PE)
64 2021-04-17 chest pain Lymph nodes hurting a lot; Hypersensitive to light; A lot of dizziness; Nausea; Headaches; affecting... Read more
Lymph nodes hurting a lot; Hypersensitive to light; A lot of dizziness; Nausea; Headaches; affecting all organs; Chest pain; Felt like the Covid-19 vaccine was hydrating eyes/Film on eyes; Losing vision; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), first dose via an unspecified route of administration on 16Mar2021 10:30 (at the age of 64 years old), single dose for covid-19 immunisation. Medical history included ongoing thyroid (disorder) (Unspecified thyroid condition). It is the vaccines with aluminum and bovine extract that she knows that she can't handle. Caller reported that she got a flu vaccine at work and that she definitely got the flu within a few minutes of receiving the flu vaccine. Caller reported that another time after receiving the flu vaccine, she definitely got the flu but she was unsure of the time frame. Caller reported that she did have the flu vaccine several times but that two times, the flu vaccine definitely gave her the flu. She has 3 brothers and that one of her brothers that she is a caregiver for has Type 1 Diabetes. Her brother just felt like he had to have 2 vaccines several years ago and that he received the pneumonia and flu vaccines. Her brother was hospitalized within days of receiving the flu and pneumonia vaccines. Her brother was placed in the ICU for heart patients and the medical staff at the hospital was not sure if her brother was going to live. She couldn't remember how long her brother was hospitalized for, caller stated she thinks maybe around 10 days.She knows what she knows, her 2 other brothers were also hospitalized as children. She didn't know if her brothers had vaccines before they were hospitalized but that she would bet money that vaccines they had received are what resulted in hospitalization.When hospitalized, her second brother was not expected to live. At the time of the event, her brother was only 1 or 2 years old. Her brother's infection was so bad that the hospital sent blood to the CDC and that the CDC couldn't figure out what was wrong with her brother.The hospital kept giving IV antibiotics to her brother and he lived. Her third brother hospitalized around 5 years old with pneumonia during the summer. She didn't know if her brother had received any vaccinations at that time. She just thinks the vaccines did that to them but she doesn't know that. Someone gave her first brother the information on the pneumonia and flu vaccines he received prior to his hospitalization. She didn't have information regarding the details of the vaccines that her brother received.The facility where her first brother was vaccinated with flu and pneumonia vaccines would not give her the information on the vaccines that her brother received. Caller reported that it was a really hard time to fight the facility for that information and she was shocked the facility wouldn't give her the requested information. Caller reported that they wouldn't give her any medication records or anything. Caller reported that it was a bad time for her to fight it, and that she will eventually go back and tell them they have to give her the information.Her brother that she is a caregiver for and that was hospitalized after receiving the flu and pneumonia vaccines also had the Covid-19 vaccine on 16Mar2021. Caller reported that she had been more concerned about her brother having a reaction as he has serious health issues, including Type 1 Diabetes and a heart condition. Caller reported that her brother stated that he's fine and to the caller, her brother seems fine. Concomitant medication included levothyroxine. Patient has experienced that the Pfizer Covid-19 vaccine made her hypersensitive to light on 20Mar2021. She is losing vision on Mar2021 because of the hypersensitivity to light. On 20Mar2021, patient had a lot of dizziness and nausea. It is effecting all of her organs. She has had headaches, chest pain. The Covid-19 vaccine is affecting all of her organs. Yesterday, 30Mar2021, her lymph nodes were hurting a lot, at least she thinks it was her lymph nodes. All of her organs that have been affected by the Covid-19 vaccine and that it seems like it moves day to day. She is mostly sensitive to UV light but is also sensitive to artificial light. She thinks that the hypersensitivity to light has improved a little bit but it's still a problem. The hypersensitivity to light was the absolute worst on 20Mar2021. She doesn't know how much she is still dizzy when asked if it was still ongoing. She added she has been taking Benadryl and ginger for the dizziness and nausea and it helps a lot.She has been taking ginger for the nausea, and if she still has a little, it's not as much.Today is an overcast day and that it's an easy day for her. Caller reported that bright, sunny days are the worst.She was unsure of when the vision loss occurred but stated that she knew by 20Mar2021 that she had lost vision. She didn't know if she was continuing to lose vision but she can tell she lost vision. She did have a headache in the evening on 16Mar2021 after receiving the Covid-19 vaccine. She thinks the headache occurred in the evening on 16Mar2021.She may have had some headaches between 16Mar2021 and 20Mar2021, but that the headache she had on 20Mar2021 was a horrible headache.She is still getting headaches. She would say the headaches are a little better but she is still having them.She is having headaches that she doesn't think she would normally have. She wasn't having headaches before receiving the Covid-19 vaccine.She thinks she did have headaches between 16Mar2021 and 20Mar2021, but 20Mar2021 is when the headaches really hit her.The chest pain is intermittent and that the chest pain coincides with when the light is affecting her. When it's UV light, more so in the afternoon on sunny days, but technically the artificial light in the evening some days bothers her too.She doesn't think her lymph nodes were bothering her before 29Mar2021. Her lymph nodes are ok this morning, 31Mar2021.Different organs have hurt at different times. The effect on organs started within minutes of getting the Covid-19 vaccine.She could feel her eyes and that her eyes felt different within minutes of getting the Covid-19 vaccine. It felt like the Covid-19 vaccine was hydrating her eyes on 16Mar2021 but at the time it felt good. Afterward she was freaking out because she was concerned about her eyes.In the evening of 16Mar2021, it seemed like there was a film on her eyes and she had a headache.On 17Mar2021, 18Mar2021, and 19Mar 2021 she had headaches that she wouldn't have normally had.On 20Mar2021 different organs started hurting.Her biggest concern was the chest pain. After looking back on it, the chest pain may have started between 17Mar2021 and 19Mar2021 also.The effect on her organs from the Covid-19 vaccine occurs on different organs at different times on different days. The effect today isn't bad because it overcast outside and that her organs are really affected when she is exposed to a lot of light.She had 2 blood tests yesterday at her primary care doctor. The doctor ordered labs for VEGF and Leptin. She doesn't get vaccines.No Prior Vaccinations (within 4 weeks). The outcome of the event Photophobia, Nausea, Headache, Lymph node disorder was recovering; other events was unknown. Follow-up attempts are completed. No further information is expected.
64 2021-04-17 heart rate increased This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on 06Apr2021 13:00 at single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 06APR2021 at around 1PM. She woke up in the middle of night (she usually does so). When she woke up this morning and had a cup of tea, noticed that she was "somewhat sensitive to caffeine" which is unusual because she liked drinking coffee. On 07APR2021, her heart rate (HR) is 96 beats per minute (BPM), which is high because her usual HR is 60 BPM. Her oxygen levels are normal (98%). She asked about this possible side effect to the vaccine, aside from her sore arm. She asked if she could take Ibuprofen. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021389552 Same reporter/drug/AE, different patient
64 2021-04-17 atrial fibrillation heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe ... Read more
heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours; body feels like hit with mac truck; tired; This is a spontaneous report received from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm at age 64 years, on 29Mar2021 14:25 (Batch/Lot Number: ER8732) as single dose, for COVID-19 immunisation. Medical history included atrial fibrillation as a pre-existing condition that normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most and overweight from unspecified date but working on it. Only she has heart history in her family. The patient's concomitant medications was none. Patient historically took first dose of BNT162B2 (Lot: EN6199) with anatomical Location of left arm on 08Mar2021 around 1300 for COVID-19 immunization and flu vaccine received back in 2020 for immunisation. Patient reported that she had the second dose of the Pfizer COVID Vaccine on Monday, 29Mar2021 and three hours later, her heart started fibrillating for 36 hours. She has a pre-existing condition of atrial fibrillation and normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours. Patient contacted the doctor right away via phone. Her doctor, an electrophysiologist, stated not to eat or drink anything after midnight and of patient was still in atrial fibrillation in the morning they would have to perform a cardioversion, with the paddles. Doctor believed this could happen and said its a delicate balance when you put anything else into the system that it could affect persons. On 31Mar2021 at 05:15 that morning, the patient went out of atrial fibrillation and back into normal sinus rhythm. Patient only called the doctor and would have had to go in today if the fibrillation did not stop. Patient also stated that well, it was not a good thing to fibrillate for that long, with due time it can cause congestive heart failure and stated its dangerous. Patient was resting at the time of report and was relieved she is not fibrillating anymore. Patient reported that her body feels like it was hit with a mac truck on Mar2021. Heart fibrillating for 36 hours makes you really tired. The outcome of the event 'heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours' was recovered on 31Mar2021 at 05:15 in the morning, while for the rest of the events it was unknown. Follow-up attempts are completed. No further information is expected.
64 2021-04-17 heart rate decreased, transient ischaemic attack possible pinched nerve; TIA; heart rate is low anyways from the medications but it dropped to 35 whe... Read more
possible pinched nerve; TIA; heart rate is low anyways from the medications but it dropped to 35 when she was in the hospital/heart rate dropped; her right arm, the right side of her face, and her right knee were numb/ she has numbness in her right finger and right thumb; face feels like its burning; her vision was kind of blurry; sensational loss in her right hand; caller's sclera looked like her eye was bleeding and her pupil started turning a different color.; caller's sclera looked like her eye was bleeding and her pupil started turning a different color.; eye was super red; rupture of a blood vessel in her eye; blood clot in eye; This is a spontaneous report from a contactable nurse (reported for herself). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER2613, expiry date not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 at a single dose for covid-19 immunisation. Medical history included ongoing hypertension from 1900 wherein blood pressure was high prior to her atrial fibrillation medications; A fib (atrial fibrillation) from 2016 and ongoing; and ongoing heartrate low. As a child the caller had the vaccine in the sugar cube (unspecified) and her mouth was swelling from it; and stated that patient's sister was hospitalized after receiving the same vaccine. Family medical history included mom has hypertension. Concomitant medications included apixaban (ELIQUIS) taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 5 mg twice a day; sotalol taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 80 mg, twice a day; and diltiazem taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 180 mg, once a day. The patient was a healthcare worker and she has had friends who have died from covid. The patient had no previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations (within 4 weeks). The patient stated she had the first dose of the vaccine and had a TIA (Apr2021) and rupture of a blood vessel in her eye 20Mar2021. The TIA was on Monday (Apr2021) and she was supposed to have her second dose tomorrow (09Apr2021). She stated she may get it but she is not taking it tomorrow because she is still having residual symptoms. She asked what the length of time she can wait to get it before she has to restart. Patient reported that after she got her first vaccine she had a ruptured blood vessel in her eye the next day (20Mar2021). She put warm and cool compresses on her eye then the ruptured blood vessel subsided. The ruptured blood vessel came back again a few days later and this time it was the entire sclera. She developed blood clots in her eye and the doctor said it probably wasn't from the vaccine (Mar2021). She was supposed to get her second dose of the vaccine tomorrow 09Apr2021 but she was going to hold off for now. She then had a TIA (Mar2021) and became hospitalized because of it from 06Apr2021 to 07Apr2021. The patient has ongoing atrial fibrillation but has been taking her medication religiously. She believed that the TIA was from the vaccine as there was no explanation as to why it happened. Her heart rate was low anyways from the medications (dates unspecified) but it dropped to 35 when she was in the hospital (Apr2021). The patient's primary care provide was not the attending in the hospital when the caller was hospitalized. Furthermore, it was reported that on 21Mar2021, patient's eye was super red but only on one side of her left eye. On Tuesday, 22Mar2021, caller went to see her primary care provider and they told the patient to put a warm compress and no eye drops in her eye, that helped. Then that Friday, 25Mar2021, the patient's sclera looked like her eye was bleeding and her pupil started turning a different color. Then last Monday (Apr2021), the patient woke up and her right arm, the right side of her face, and her right knee were numb she got up and went to see if she had a facial droop and did not. The patient thought it was from her sleeping wrong, but these symptoms did not go away. The patient went to the Emergency Room where they did a CT of her head and neck, with and without contrast which was negative. The patient was admitted on 06Apr2021 to the observation unit where they did an MRI and ECHO, which were both negative and she was diagnosed with a TIA and possible pinched nerve (Apr2021). The patient denied any heavy lifting prior to this event other than normal day to day things. The patient was discharged on Wednesday 07Apr2021. The patient's face felt like its burning, she has numbness in her right finger and right thumb. Physical therapy and occupational therapy said the patient should be okay but to be careful with things that were hot because she was at risk of burning herself. The second time the patient's eye became red, her vision was kind of blurry (Apr2021) and she didn't know if the blood was in her pupil. The only deficit that the patient has now is sensational loss in her right hand (Apr2021) and that should improve per the occupational therapist at the hospital. The caller was supposed to get the second dose of the vaccine on 09Apr2021 but she doesn't want to take it while she is having these symptoms. Results of tests and procedures for investigation of the patient included: head ct with and without contrast: negative on 06Apr2021; MRI brain: negative on 06Apr2021; Echocardiogram: negative on 07Apr2021; speech evaluation: passed on 07Apr2021. The patient asked what the efficacy is after one dose and if a booster will be needed since she is only protected for 6 months. Patient asked if she needed to restart the series of vaccinations if she doesn't get the second vaccine tomorrow 09Apr2021. The events ruptured blood vessel in eye, blood clot in eye, sclera looked like her eye was bleeding, eye was super red were reported as serious medically significant, and heart rate dropped as life-threatening. As reported, the events required emergency room and physician's office visit. Therapeutic measures were taken as a result of the events rupture of a blood vessel in her eye, and eye was super red. The outcome of the events reported was unknown. As per reporter, the events ruptured blood vessel in eye, blood clot in eye, and heart rate dropped were related to the covid BioNTech vaccine.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
64 2021-04-18 loss of consciousness Passed out on Monday hit head and got a concussion.Went to ER had . Headaches caused by optical and ... Read more
Passed out on Monday hit head and got a concussion.Went to ER had . Headaches caused by optical and vestibular systems does to hitting head. Bump on right side of head that continues to hurt.Balance is off due to vestibular. Some short term memory issues.OT and PT.
64 2021-04-21 hypertension, chest discomfort, chest pain Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my lef... Read more
Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest. My chest was tight. It hurt in my neck and shoulder and chest to take a deep breath. Shortly after, I felt jittery inside & started getting chills. The backs of my legs were quaking against the chair and I got really cold. My blood pressure went up to 149/78. I also had one bout of diarrhea.
64 2021-04-24 palpitations I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hea... Read more
I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hear it, could felt it in my chest. Then trembling; heart palpitations and it was skipping and trembling off and on; arm is sore; weird feeling; trembling; trembling, shaking and she thought she was going to have a seizure, she had no control over her muscles; muscles twitching, like if I had no control over the muscles; she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot; didn't feel good last night; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 13:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 64 years old. Medical history included cholesterol (abnormal, takes cholesterol medication 3 times a week as she gets side effects from it), cutaneous lupus (She always has to do bloodwork and goes in every 3 months), heart problem that is not major (she takes 1 medication, patient stated once in a while she sees her cardiologist every 6 months and she did get a halter monitor for 24 hours for a week and they take an average and said it wasn't as bad and knows that is a problem), 2 cervical spine surgeries, arthritis, allergic to contrast dye for CAT scans, allergy to medications (sensitive to medications), shrunk a lot because of issues, and had surgery which shrunk her because of her spine from an unknown date. Concomitant medication included atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal from 2016 and ongoing; and nadolol (CORGARD) taken for an unspecified indication from 2001 and ongoing. Patient's son got COVID on an unspecified date. Patient previously took generic atorvastatin which made her sick on an unspecified date and LIPITOR and experienced muscle weakness on an unspecified date. No additional vaccines administered on the same date of the Pfizer vaccine. No prior vaccinations. Patient never got a flu shot as she was scared. On 06Apr2021, her arm was sore which is normal. Normal side effects from the arm did not concern her, patient had no fever nothing else. She stated she came home and felt like she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot and she made sure of that. At 19:00 (also reported as 7-8pm), patient experienced her heart was skipping really bad. Patient could hear it and could felt it in her chest. Patient clarified her heart was not fast, it was more skipping, and she could feel it beating in her throat. She commented has a problem but that has not happened in a long time. Patient then experienced trembling described as lots of body trembling concerned like a seizure. She thought she was going to have a seizure. It was not chills; she had no fever or anything. The trembling came on and off. Her muscles were twitching, like if patient had no control over the muscles. Patient did not feel dizzy, it was a weird feeling. She did not feel good. On 07Apr2021 at 02:00, patient felt very tired and weak, her heart was better. About 02:00 she fell asleep. She woke up at 6:30 and she felt tired but that does not bother her. Her concern was the body trembling. She called her doctor but was not available. She was advised that it does not sound like a symptom of the vaccine. She was worried she needs to go to the cardiologist and see what is happening. She stated if it keeps happening, she will go, and she does not know if this is a side effect other people are reporting. Patient was wondering if this is a reaction as she cannot find it, one says a severe reaction is a fast heartbeat, really fast and skipping and she does not know. She expected anything, tired, headache, muscle aches but these did not happen, but she was expecting them to. Patient is wondering why her heart is doing that is it from the shot or what is going on with her which is weird, and stated the shaking, trembling of her whole body is weird. She mentioned she is sensitive to medication and gets reactions to a lot of medications. She stated this is why she was scared to get the vaccine and what the reaction was with the 1st. Patient stated her heart is a lot better than it was last night, that she feels very tired and feels unwell. She stated she took her temperature (Apr2021) and she had no fever, no nothing a little unwell, a weird feeling. Patient stated she is not trembling anymore and has no heart skipping, that went away about 2am when she fell asleep for a few hours (also reported as went away after about an hour, she had it off and on 3-4 times in an hour). Patient clarified she has not had testing done for the reported symptoms. The patient stated she is concerned and does not know what to do about second dose, which is scheduled for 04May2021. She does not if it was a reaction and stated she is very sensitive to medicine. Events did not require emergency room and physician office visit. Outcome of the event heart was skipping, tremor and palpitations was recovered on 07Apr2021 02:00 while unknown for the other events. Follow-up attempts are completed. No further information is expected. Lot number has been obtained.
64 2021-04-24 loss of consciousness passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head seve... Read more
passed out two times; Left arm shoulder and neck completely numb; Left lower section of my head severe pain; dizziness; vertigo; nauseous; heavy sweats; my head feels very foggy; Having spots of memory issues; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 30Mar2021 11:30 (Batch/Lot Number: EM9810) as single dose for covid-19 immunization. Medical history included asthma, neuropathy, high cholesterol, and several allergies from an unknown date. The patient has no history of COVID prior vaccination. She was not COVID tested post vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (Lot number=EN6200) on 09Mar2021 12:15, on left arm for COVID-19 immunization. The patient experienced having left arm, shoulder and neck completely numb for four days since 30Mar2021, 19:00. Left lower section of her head with severe pain; she had dizziness, vertigo and was nauseous. She started having heavy sweats and passed out two times. She reported it has been a week since she had the shot and she was still dizzy and her head feels very foggy. She was also having spots of memory issues. The events were experienced on 30Mar2021, 19:00. No treatment was received for the events. The outcome of the events was not recovered from dizziness, and recovered with sequela from "Left arm shoulder and neck completely numb" on 03Ape2021, and recovered with sequelae on an unspecified date for other events..
64 2021-04-24 loss of consciousness stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous... Read more
stomach ache; Day two past out; bodyaches; vomited; Headache; nauseous; fever; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0151), via an unspecified route of administration, administered in left arm on 05Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Mar2021 for COVID-19 immunization. The patient had no other vaccine in four weeks. It was reported that on day two (06Apr2021), the patient past out and vomited. The patient also experienced headache, nauseous, fever, bodyaches on 06Apr2021; and stomach ache on 10Apr2021. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The outcome of the events was not recovered.
64 2021-04-27 blood glucose increased, cardio-respiratory arrest ? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient ... Read more
? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient is sick with vomiting and diarrhea ? Friday, April 9th ? Patient is delirious and still sick with vomiting and diarrhea. She is also has pain in her stomach. An ambulance is called to take her to the hospital. The hospital determines her white blood count is elevated, indicating an infection. Blood sugar is very high ? approximately 400. Covid test is negative. She is restless upon arrival. She tries to climb out of bed continuously. She is restrained. o Saturday, April 10th ? Patient is running a fever and is in pain. She is also confused and doesn?t recognize her oldest sister. Meds are administered to handle both items. (Toradol?). Blood sugar around 200. She continuously counts and calls for Mother and Father. Patient continues to be restless o Sunday, April 11th - at request of family, a CT scan is done of her stomach and abdomen. Nothing is found. Potassium was at 3.2 (normal is 3.5) so she received an IV drip to help with potassium levels. Sugar ? 206. Later drops to 176. Patient calms down some. She is still confused and doesn?t recognize her oldest sister. ? Monday April 12th ? the hospital attempts to do an MRI, but patient panics. This is a closed MRI and her 1st husband died in one. The MRI isn?t done. ? Tuesday, April 13th ? she is asked by the doctor to state her name and wiggle her toes. She complies. Doctor orders speech therapy. She is sedated for an MRI and a CT scan. Both are successfully completed. She sleeps for the rest of the day. Blood sugar ? 274 @ 5:09pm. ? Wednesday, April 14th ? Patient was asleep all day. Most of the day she isn?t responsive when nurses come in and do things like take blood. She normally responds even if she is asleep. Around 5pm she starts to respond and make noises; she briefly opens her eyes then falls asleep. She continues to run a temperature. ? Thursday, April 15th ? Patient is asleep most of the day. She is responsive when nurses do things like take blood. A spinal tap is performed. There was mention of dementia. Hospital is sharing little information, varying from she is retreating into herself vs. something worth isolating is going on. Temp was 102.3 at 7:37, but later dropped to 99.3 without meds. Dr. (neurologist) provides an update to the family. Tests so far are negative. EEG showed sleeping brain (she was asleep during test). MRI showed nothing. Spinal tap negative so far. No infection or anything has shown up. Orders another EEG and MRI ? Friday, April 16th ? Patient tried to open her eyes. ? Saturday, April 17th ? a met code was called on her and she was moved to ICU. A circulation issue was found in right leg. Occlusion was really bad. Initially the doctor was concerned about blood clots. None were found, just swelling. Pressure was relieved. Blood pressure issues. She was put on 2 blood pressure meds, at least. She was dehydrated and acidic. Diabetic ketoacidosis was mentioned. A cytokine storm was expected. ? Sunday, April 18th ? blood pressure not stable. She was put on dialysis. Peripheral circulation was worse. ? Monday, April 19th ? she coded around 5am. Doctors were trying to save her. She passed away about 30 minutes later .
64 2021-04-27 blood clot, cerebrovascular accident strokes signs; Two blood clots in the veins in legs; This is a spontaneous report from a contactable... Read more
strokes signs; Two blood clots in the veins in legs; This is a spontaneous report from a contactable consumer. A 64-year-old female consumer (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EN6199/EN6207 (as reported)) intramuscular into the left arm on 10Mar2021 (at the age of 64-years-old) at single dose for COVID-19 immunization. She received the second dose of BNT162B2 dose on 31Mar2021 (lot number unknown). Medical history included high blood pressure and GERD. Concomitant drugs included Toprol 25mg, oral , twice a day for blood pressure stated ''in Feb some time she don't know'' and Protonix 40mg, oral twice a day for years for GERD. The consumer reported that 'she got her first vaccine and she has had the strokes signs''. Further she reported she got her first vaccine dose, then she had leg pain, she went to see the doctor and ordered a doppler. She was put on blood thinners and three days later she got two blood clots in the veins of her legs, right. On 20Mar2021, her leg pain went pretty severe since I had the blood clot, when I got the second shot, it was still there. On 27Mar2021 she started treatment receiving Eliquis 5mg, twice a day for the blood clot and she did take a Physical therapy. When she got the second vaccine dose on 31Mar2021 she was on blood thinners. At the time of reporting the outcome of the event was reported as 'hasn't gotten better, it's the same not better not worse.
64 2021-04-30 heart rate increased, hypertension, palpitations body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart... Read more
body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart rate/rapid heart rate; Angioedema; having a hard time finding food to eat; water makes tongue swell and tingle; lip swelling; respiration changes from clothing; extreme hypersensitivity; heart racing; tongue tingling; rapid breathing/rapid respirations; nervousness; chills; burning sensation in her body; skin itches; bumps on back and abdomen; lock jaw at night; skin feels like it is thinning out; breathing stops and starts at night; electrical charges that were prickly in her body; warm flush; high blood pressure/blood pressure went up; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On an unspecified date, the patient experienced body is responding to food, water and medicine like it is foreign and she is frustrated. On 17Mar2021, the patient experienced high blood pressure/blood pressure went up (which required an emergency room visit), electrical charges that were prickly in her body, and warm flush. On 18Mar2021, the patient experienced angioedema, extreme hypersensitivity, heart racing, tongue tingling (which required an emergency room visit), rapid breathing/rapid respirations (which required an emergency room visit), nervousness, chills, burning sensation in her body, skin itches, bumps on back and abdomen, lock jaw at night, skin feels like it is thinning out, breathing stops and starts at night, having a hard time finding food to eat, water makes tongue swell and tingle, lip swelling (which required an emergency room visit), and respiration changes from clothing, elevated heart rate/rapid heart rate (which required an emergency room visit). The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date, blood pressure measurement: had gone down on 17Mar2021, blood pressure measurement: 164/100 on 17Mar2021, blood pressure measurement: 176/100 on 17Mar2021, blood pressure measurement: went up on 17Mar2021, heart rate: rapid on 18Mar2021, heart rate: elevated on 18Mar2021, respiratory rate: rapid on 18Mar2021. Therapeutic measures were taken as a result of high blood pressure/blood pressure went up (hypertension). The outcome of electrical charges that were prickly in her body, body is responding to food, water and medicine like it is foreign, warm flush and frustrated was unknown. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427769 Pfizer
64 2021-05-03 blood pressure increased, hypotension, chest pain, chest discomfort Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotensio... Read more
Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotension; Weakness feeling; Generalized erythema; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Diarrhoea; Vomiting; Throat closed in; the sides of the throat, down my neck , straight over my chest felt as if someone was squeezing me, chest felt heavy; Potential anaphylactic reaction; Difficulty breathing; severe brain fog; Severe chest pain hard to breath felt as if being smothered; difficult to sleep nights before as felt wired after the shot; bp slightly elevated 140/80; Became very groggy; eyes heavy, had about 3 sleep attacks; 3 sleep attacks; This is a spontaneous report from a contactable Health Care Professional (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN4206) at single dose, intramuscularly, in the left arm, on 05Mar2021 at 10:00 AM, for COVID-19 immunization. The patient also received hylan g-f 20 (SYNVISC), via an unspecified route of administration, in knee, on 04Mar2021, at single dose, for an unspecified indication. Relevant medical history included narcolepsy from an unspecified date, in 1973, cataplexy from an unspecified date, complex regional pain syndrome (CRPS) from an unspecified date, in 2003, osteoporosis from an unspecified date, gastrooesophageal reflux disease (GERD) from an unspecified date, hypertension from an unspecified date and arthritis from an unspecified date, in 2003. Concomitant medications included methylphenidate hydrochloride (RITALIN), imipramine, baclofen, atenolol, rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), imipramine hydrochloride (TOFRANIL), montelukast sodium (SINGULAIR), acetylsalicylic acid (BABY ASPIRIN) and clonidine, all taken for an unspecified indication, start and stop date were not reported. The patient reported allergy for drugs like lisinopril, spirolactone, ghb (gamma-Hydroxybutyric acid), epinephrine and all seizure type medications. The patient became very groggy, felt eyes heavy, had about 3 sleep attacks, on 06Mar2021, at 13:00. Also reported difficulty to sleep nights before as felt wired after the shot (insomnia) and bp was slightly elevated 140/80 on 07Mar2021. On 27Mar2021 at 13:00, throat closed in, felt the sides of the throat, down her neck, straight over her chest felt as if someone was squeezing her, chest felt heavy (severe chest pain hard to breath, felt as if being smothered, throat closing in severe chest heaviness). Severe brain fog. Potential anaphylactic reaction and difficulty breathing were reported. On an unspecified date, the patient experienced angioedema, shock, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus with skin rash, diarrhoea and vomiting. Decrease level of consciousness and loss of consciousness were not reported. The patient underwent lab tests and procedures which included oxygen saturation: normal on 06Mar2021 and blood pressure measurement: 140/80, slightly elevated, heart rate: 99, respiratory rate: 20 on 07Mar2021. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient did not have COVID prior to vaccination and the patient did not test COVID post vaccination. The patient recovered from throat constriction, chest heaviness, potential anaphylactic reaction and difficulty breathing. Clinical outcome of angioedema, shock, chest pain, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus, skin rash, diarrhoea and vomiting was unknown. Outcome of the other events was reported as recovering. Follow up attempts are completed. No further information is expected. Follow up (26Mar2021): New information received from a contactable Health Care Professional includes: adverse events added, clinical course and case seriousness updated from non-serious to serious. Follow-up (20Apr2021): New information received from a contactable Health Care Professional includes: medical history, concomitant medications details and additional adverse events added (Potential anaphylactic reaction and difficulty breathing added as additional adverse events). Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of serious events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
64 2021-05-04 chest discomfort Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down ... Read more
Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down to 2.5 inches by and inch.; allergic reaction; when they injected the vaccine that it burned; lethargic; half a bandage was covered in blood; it felt like three baseballs are sitting on her arm.; The muscles were so tight in her ribcage that she couldn't take a deep breath.; She states that the front of her shoulder, the sides, and the back of her arm was all hard and tense.; teeth chattered after getting the vaccine; Dizziness; difficulty breathing/hard time breathing; headache; fatigue; can still feel where the injection went; feels like an electrical shock; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; itching; muscle aches; joint aches; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; arm pain that radiated under her arm to her rib cage; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; hit a nerve upon vaccination; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), dose 1 , single dose via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included hypertension from an unknown date and unknown if ongoing History: Caller states that she does have health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic, diabetes mellitus from an unknown date and unknown if ongoing History: She has health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic. Hostorical vaccine included tired when she gets flu shot and got the thing where she couldn't lift her arm up and it hurt down the ribcage; still hurts in the lower quarter along the back side of the rib cage; still tender and goes to the bottom where the rib cage ends when she got the pneumonia shot . She is not sure if it effects the lungs more. The patient had no family history relevant to the adverse events. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient experienced kidney infection, urinary tract infection (UTI), itching all over and that lasted two days and didn't get hives, muscle aches and in the beginning she couldn't get out of bed, fatigue, arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting, hurts down her arm, nerves were jerking, feels like an electrical shock in her, would feel like her eyebrow or her nose would twitch in the center; it was so bizarre, starting at her temple going down throughout her body to her arms and fingers, it was jerking like lightening fire, the jerking started at the temple on right side and went down the face, it made her knees and ankles jerk, her arm was jerking, she still has some jerking in her left hand so it jerks over to the thumb, she can't control that, the nerves were doing their own thing, her leg and knee would move with out her wanting it to, that the moving is still happening in her shoulder, arms, knees, leg, and foot and joint aches, they hit a nerve upon vaccination and can still feel where the injection went on 27Mar2021, headache and difficulty breathing/hard time breathing and changed her position to sitting up more than laying down on 28Mar2021, dizziness on 29Mar2021, really tired for a good week and a half, size of her arm at the injection site is down to 2.5 inches by and inch, arm felt like it was big in the front, on the side and the back, it felt like three baseballs are sitting on her arm, allergic reaction, it burned when they injected the vaccine, more lethargic than normal on an unknown date. It was also reported that she had difficulty breathing, described as tightness around her rib cage on day 3 and was having a harder time breathing when laying down on day 2.5-3. She states that it still hurts down her arm. It took 4 days for her to be able to lift her arm to her head. She didn't want to lift up because it was still tender around the chest area, especially on right side. it was still tender around the chest area, especially on the right side. The muscles were so tight in her ribcage that she couldn't take a deep breath. On an unknown date, half a bandage was covered in blood and the front of her shoulder, the sides, the back of her arm was all hard and tense and teeth chattered after getting the vaccine. There was no laboratory tests performed. Treatment was received for difficulty breathing/hard time breathing and fatigue. She used her inhaler for her breathing and took ibuprofen (ADVIL, lot: RA467, expiration date: Jul 2022) liquid gel minis at night for her pain. She was prescribed cephalexin. She had an albuterol inhaler on the 28th, 29th, 30th, and 31st, so she took that treatment for 3 days. She was only trying to use one dose of the albuterol inhaler because it can raise the blood pressure, but she also wanted to breathe easier. The muscles were so tight in her ribcage that she couldn't take a deep breath. She still has that in the right lower quarter from her back side ribcage under the arm to the side of the leg. The events did not require emergency room or a physician's office visit. The clinical outcome of Itching was recovered on 29Mar2021 and dizziness was recovered on 30Mar2021, headache recovered around 31Mar2021, unknown for her leg and knee would move with out her wanting it to, felt like three baseballs are sitting on her arm, hit a nerve upon vaccination, half a bandage was covered in blood, kidney infection, urinary tract infection (UTI), fatigue, tightness around her rib cage, size of her arm at the injection site is down to 2.5 inches by and inch, allergic reaction, injected the vaccine that it burned and lethargic and recovering for muscle aches, joint aches, difficulty breathing/hard time breathing, pain in arm, nerves were jerking and feels like an electrical shock, arm pain that radiated under her arm to her rib cage and the front of her shoulder, the sides and the back of her arm was all hard and tense.
64 2021-05-04 blood pressure increased Swollen facial/lip,, very painful arm, feeling disoriented, severe trouble breathing, very tired, fe... Read more
Swollen facial/lip,, very painful arm, feeling disoriented, severe trouble breathing, very tired, fever/chills,headache My left arm became very painful immediately after injection(the injection didn't hurt,it was after needle removed & she was getting bandage), then I started to feel lightheaded & disoriented and trouble breathing and Blood pressure elevated but it was very low immediately after injection. Didn't start feeling well until more than 2 wks after shot.
64 2021-05-07 vaginal haemorrhage feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous... Read more
feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous; It was just bile coming up; Headache; Was passing clots/were clots/in the vaginal area; Was passing clots/were clots/in the vaginal area/vaginal bleeding; Being dehydrated; couldn't hold her own weight up; stomach pain; So sick; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; A sharp pain in her side; Stools were dark tarry stringy stuff; Stools were dark tarry stringy stuff; Passing blood in her urine; allergic internal reaction; Weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age 64 years, administered in left arm on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose, for COVID-19 immunization, in order to go back to normal, without a mask so she was told she had to have one. Medical history included hysterectomy, anxiety, disorder in thyroid and cholesterol. Patient had family history of dementia, had to stay home and take care of her mom who is a heart patient and has dementia. Patient had no history of previous immunizations. Patient's concomitant medication includes unspecified medications one is for thyroid, one is for cholesterol and the other 2 are for anxiety. Patient had no prior vaccinations within 4 weeks. No additional vaccines administered on the same date. Patient's symptoms started with a headache the morning after the shot (05Apr2021), was on and off for a couple of days, lasted 3 days or so for a couple days and she took paracetamol (TYLENOL). On 09Apr2021, Friday morning, patient woke up so nauseous she couldn't hold anything down. It was just bile coming up, and she had severe diarrhea and so sick vomiting that wouldn't stop, stomach pain, couldn't hold her own weight up. She got medication at a walk in clinic and that didn't stop it. She started out at acute/urgent care, where she was taken by her daughter on Sunday, 11Apr2021, because she was feeling so bad and was tested for COVID and they said if it does not get better to go to the Emergency Room and she continued having problems. It was not COVID. They said she was dehydrated and send her home to push fluids and drink Pedialyte. Monday or Tuesday (Apr2021) she was in the ER all night (she does not remember the day because all of her days are mixed up). They did CAT scans on her abdomen and ran blood work. They didn't see anything in her abdomen. Her white blood cell count and kidney and liver function were all elevated and they said it was from being dehydrated from diarrhea and vomiting. They gave her fluids and sent her home. Within another 48 hours she still had vomiting and diarrhea, it was a clear bile and a sharp pain in her side. Her stools were dark tarry stringy stuff so she went back to the ER and waited in the lobby for 9 hours. In that 9 hours as she was waiting, she felt like she had to go to the bathroom. She was then wheeled into the bathroom and started passing blood. It wasn't coming from the urethra. It must have come form the vagina, she doesn't have a uterus. There were clots. She started passing blood in her urine but most was in the vaginal area but she has already had a hysterectomy. She was passing clots and her doctor who works in the healthcare field looked at it and said they were clots. Very shortly after, she passed the clot and the pain went away. The pain was passing clots/were clots/in the vaginal area at one point went away but she still have nausea and diarrhea and they gave her more fluids and sent her home. They didn't really want to address the vaginal bleeding. Patient have not been back and was not sure if she is still dehydrated. Patient was still pushing fluids and still not back to normal. Patient's daughter told her that since it was 5 days later it was not a reaction. Patient was thinking maybe it was an allergic internal severe reaction. Patient was weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter. She stated her daughter-in-law was doing research and found a blog and there are woman the caller's age complaining of these symptoms (unexplained bleeding) after the vaccine. She asked if this was from the vaccine. She stated she was so sick that if there is even a chance then she doesn't want the second dose. She asked if this is a coincidence or has it been reported. She stated she is trying to make a decision on if she should get the second dose because she heard other people have symptoms and take the second shot. The outcome of the events passing clots/were clots/in the vaginal area, headache, a sharp pain in her side, passing blood in her urine, passing clots/were clots/in the vaginal area/vaginal bleeding was recovered on Apr2021, while for the other events, it was unknown.
64 2021-05-10 blood glucose increased, chest pain Abdominal pain, chest pain, nausea, and dizziness
64 2021-05-10 heart attack NSTEMI (non-ST elevated myocardial infarction)
65 2021-01-05 chest discomfort After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling... Read more
After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling, sore throat and chest tightness.
65 2021-01-05 palpitations Racing heart maximum rate 156 Palpitations Anxiety Symptoms lasted approximately 4 hours
65 2021-01-05 blood glucose increased Sugar levels became abnormally high. Over 400. Insulin given to bring level back to correct level bu... Read more
Sugar levels became abnormally high. Over 400. Insulin given to bring level back to correct level but took all afternoon and evening to get it down.
65 2021-01-05 fast heart rate dizziness, tachycardia, feeling of impending doom, lightheaded feeling
65 2021-01-06 heart rate increased, palpitations Palpitations Pt. felt like she was having palpitations. VS stable. Narrative: c/o dizziness and palp... Read more
Palpitations Pt. felt like she was having palpitations. VS stable. Narrative: c/o dizziness and palpitations about 20 min. after getting covid 19 immunization; described by pt. as a "very fast heartbeat". P. 96 regularly in the 60's normally, per pt. @ 1320, BP 127/64, P 96, R 16, O2Sat 96%; at 1324 BP 124/57, P 88, R 16, O2 sat. 97%; @ 1337, BP 130/67, P 89, R 16, O2 sat..98%. d/c'd back to work at 1350 resolved. Updated in employee record.
65 2021-01-09 fainting 2 days after injection, nausea, projectile vomiting, 1 episode of unwitnessed syncope
65 2021-01-09 heart rate irregular, fast heart rate Tachycardia with first dose on Dec 17, then, with 2nd dose experienced off and on tachycardia and al... Read more
Tachycardia with first dose on Dec 17, then, with 2nd dose experienced off and on tachycardia and also irregular rhythm , no other cardiac related sequels . Second dose, 1/7/21, experienced fever on 1/8/21 of 101.6 off and on that day. Used mainly Advil and Tylenol for fever and headache.
65 2021-01-14 hypertension Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 min... Read more
Patient presented with history of anaphylaxis to shellfish. Nurse advised patient of need for 30 minute wait post covid 19 vaccine. Patient complied. After initial 30 minute wait, patient complained her mouth was dry and asked for water. Water provided, patient denied other symptoms. Based on history patient advised to wait another 20 minutes, and notify staff prior to leaving. 5-10 minutes later husband alerted nurse that she was feeling worse. Upon assessment, patient complained of swollen tongue, and difficulty swallowing. Adverse reaction protocol initiated. Client laid on cot, vitals taken, EMS called. Tourniquet applied above vaccination site, distal pulse check every 5 minutes. Nasal cannula, 4L applied. Blood pressure high, patient became flushed, complained of worsening in swallowing. Epi pen given in right thigh, Benadryl given IM in right deltoid. EMS arrived and took over care. Patient transported to hospital.
65 2021-01-14 heart rate abnormal generalized body aches; chills; heart rate in 140s; diaphoretic; dizzy; fatigue; This is a spontaneo... Read more
generalized body aches; chills; heart rate in 140s; diaphoretic; dizzy; fatigue; This is a spontaneous report from a contactable healthcare professional. A 65-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration from 07Jan2021 13:30 to 07Jan2021 13:30 at a single dose for an unspecified indication. Medical history included covid (COVID prior vaccination: Yes). Concomitant medication included valacyclovir and vitamin d3. The patient previously took ampicillin, Keflex and metronidazole; the patient had allergies with all. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020. It was reported that 9-hours post second vaccine, the patient had generalized body aches, chills, 2 hours later Heart Rate in 140s, diaphoretic, chills and dizzy. HR normalized 6 hours later. Diaphoresis lasted 10 hours. No treatment was received for the events. The patient also reported to have extreme fatigue. The outcome of the event heart rate abnormal and diaphoretic was recovered on 08Jan2021 while recovering for the other events.
65 2021-01-16 fainting Severe chills began at 10:30 pm; then fever spiked; slept fitfully and finally got up around 2 am to... Read more
Severe chills began at 10:30 pm; then fever spiked; slept fitfully and finally got up around 2 am to get a thermometer -while in bathroom the room started spinning and I fainted or passed out. I came to on the bathroom floor and managed to crawl back to the bed. There was confusion and the inability to understand what was going on. I remained in bed until the next morning when all symptoms abated except for some fatigue.
65 2021-01-17 fast heart rate, hypotension Chief Complaint: low blood pressure, tachycardia, SOB after last Friday's Covid shot. Pt. meeting S... Read more
Chief Complaint: low blood pressure, tachycardia, SOB after last Friday's Covid shot. Pt. meeting SIRS criteria with elevated lactate, WBCs, and tachycardia. Given fluid bolus and IV ABX.
65 2021-01-17 fainting Fainting episode . I was standing by a friend ,I fainted and hit my head on the floor . Regained c... Read more
Fainting episode . I was standing by a friend ,I fainted and hit my head on the floor . Regained consciousness right away and had no other subsequent events.
65 2021-01-19 chest discomfort Felt hot; chest tightness; nausea; metallic taste in her mouth
65 2021-01-19 loss of consciousness passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe head... Read more
passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP. A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 07Jan2021 11:00 at single dose for Covid-19 immunisation . Medical history included rubber sensitivity (Latex). The patient's concomitant medications were not reported. On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out with outcome of recovered , dizzy with outcome of recovered , hit the ground with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills with outcome of recovered , tired with outcome of recovered , severe headache on with outcome of recovered , vomiting twice with outcome of recovered , cold with outcome of recovered. The reporter stated the patient attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out dizzy and falling down and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-01-20 chest pain In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea a... Read more
In less than 60 seconds, I became Diaphoretic, had substernal chest pain radiating to back, nausea and eventual vomiting. This lasted for a long period of time, I asked to go to ER because I was so alarmed. I felt great all day prior to injection. I had been at work as a nurse with Mobile County Public School System, until I came to get vaccination .
65 2021-01-20 palpitations, heart rate increased, blood pressure increased approx. 5 minutes after receiving the vaccine, client started c/o racing heart. Bp was elevated and ... Read more
approx. 5 minutes after receiving the vaccine, client started c/o racing heart. Bp was elevated and pulse rate elevated, o2 was normal. EMSA was called due to racing heart. They monitored her for awhile and she refused to go to the hospital and drove herself home, where she said within 30 minutes of getting home she was fine and vital signs back to normal. she had a physical exam 1/20/21.
65 2021-01-21 blood pressure increased Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) ap... Read more
Patient began to experience nausea, dizziness, generalized weakness, and an elevated BP (209/101) approximately 5 minutes after receiving the 2nd dose of the COVID vaccine. The patient was taken to the emergency department for further workup. In the ED, the patient was given acetaminophen and ondansetron with resolution of all symptoms except generalized weakness and fatigue. Workup in the ED was negative, and the patient was discharged home.
65 2021-01-21 blood pressure increased Patient began to experience nausea, dizziness, generalized weakness, and an elevated blood pressure ... Read more
Patient began to experience nausea, dizziness, generalized weakness, and an elevated blood pressure (209/101) approximately 5 minutes after receiving the 2nd dose of the COVID-19 vaccine. The patient was taken to the emergency department for further workup. In the ED, the patient was given acetaminophen and ondansetron. Workup was negative, and the patient was discharged home.
65 2021-01-21 pulse abnormal Patient reported feeling numb, dizzy, and short of breath. Assessment revealed a thready pulse. Pat... Read more
Patient reported feeling numb, dizzy, and short of breath. Assessment revealed a thready pulse. Patient complained of tightness in her throat. Epi administered by observing nurse.
65 2021-01-22 fainting Severe nausea, syncope, headache
65 2021-01-22 chest discomfort Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and... Read more
Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and outside, throat tightening, lungs heavy , not, and tightening. Body heavy. Mind disconnected. Happened with in 5 minutes of injection.
65 2021-01-24 chest pain, chest discomfort PT RECEIVED COVID VACCINE AT 15:38 PT C/O AFTER 1 MIN OF CHEST PAIN AND SHORTNESS OF BREATH. PT REP... Read more
PT RECEIVED COVID VACCINE AT 15:38 PT C/O AFTER 1 MIN OF CHEST PAIN AND SHORTNESS OF BREATH. PT REPORTS H/O ANAPHYLAXIS REACTION TO FISH AND NO OTHER ALLERGIES WERE REPORTED,PT STATES FEELINMG SAME SYMPTOMS AT THIS TIME. VITALS WERE TAKEN 169/89 p. 104 PULSE OX% 95. PT WAS SPEAKING IN FULL SENTANCES AND DID NOT APPEAR IN RESPIRATORY DISTRESS ,PT REPORTED CONTINUED TO FEEL CHEST PRESSURE AND TIGHTNESS IN THROAT, AT THIS POINT EPINEPHRINE 0.3 ML WAS ADMINISTERED BY RN ON LEFT THIGH AND 911 WAS CALLED. ON ARRIVAL OD PARAMEDICS AND EVALUATION OF PT REPORTED FEELING BETTER AFTER EPINEPHRINE AND DECLINED TO GO TO ER. PT LEFT THE CLINICON HER OWN IN STABLE CONDITION.
65 2021-01-24 heart rate increased, hypertension Raid heart beat headache chills and extremely high blood pressure
65 2021-01-25 blood pressure increased A very high spike in blood pressure. My normal BP is 117/74. For about 4 hours after the vaccinat... Read more
A very high spike in blood pressure. My normal BP is 117/74. For about 4 hours after the vaccination was administered, my BP was 158/95.
65 2021-01-25 atrial fibrillation I have been in Afib since approximately 2 hours after receiving the vaccine. I do have a diagnosis ... Read more
I have been in Afib since approximately 2 hours after receiving the vaccine. I do have a diagnosis of Afib but am not currently taking medication for it. Until yesterday I have only periodic episodes.
65 2021-01-25 heart rate abnormal post vaccine 15 minutes pt. reports dizziness. EMS evaluation: HR 50-56, pt. reports heart rate not ... Read more
post vaccine 15 minutes pt. reports dizziness. EMS evaluation: HR 50-56, pt. reports heart rate not usually low. when standing up with EMS, pt. (R) leg weakness. Husband reports vomiting earlier in day. EMS to local hospital.
65 2021-01-26 cerebrovascular accident Notified by a secondary source the following information. Patient was admitted to the hospital for a... Read more
Notified by a secondary source the following information. Patient was admitted to the hospital for a stroke. The hospital discovered the patient had a stroke a week prior to vaccination. Patient pace maker had been faulty and patient INR may have been lower than therapeutic. Unable to speak directly to patient at this time to confirm these events. Actual progression unknown. Understood patient is improving.
65 2021-01-26 loss of consciousness When I signed up for the vaccine, the website said that i was at high risk for the vaccine and would... Read more
When I signed up for the vaccine, the website said that i was at high risk for the vaccine and would need to wait 15-30 minutes after the injection. I checked with doctor re: this warning and she felt the vaccine was still beneficial but to do my research and make a decision. I received the vaccine at the Center. I sat down as instructed. 5 minutes later, something felt off and I removed my protective visor. A paramedic came over about a minute later and asked if i was ok. I said that i didn't feel well. He said that he was going to get a chair with wheels for me and at that time i must have passed out. The next thing that i remember was waking up laying on the floor. My husband said that there were 4 paramedics in attendance. The primary paramedic was telling me that my BP was 72/60. An ekg was being run, an iv inserted and run full force. they checked my blood sugar which was fine. The primary paramedic kept talking to me to check my level of consciousness. I was there for quite a while. Not sure who the paramedics checked with, but they decided that i needed to go via ambulance to the hospital. The paramedics were very concerned that the ambulance go to the back door to pick me up so others getting the vaccine would not be frightened. I was transported to Medical Center for further evaluation. I was there for a few hours and my labwork was normal. EKG and chest xray were completed as well as cardiac monitoring. I called doctor's office the next morning to notify her of the event. It was very scary!!!
65 2021-01-27 heart rate increased, hypertension Had very red face and hands. My BP felt high, and my heart rate was a bit higher. Took 1 Benadryl a... Read more
Had very red face and hands. My BP felt high, and my heart rate was a bit higher. Took 1 Benadryl and waited an additional 15 minutes. When I got home I used my rescue inhaler. Felt much better and more relaxed . Took BP. Systolic was elevated to 147. Diastolic was in good range. Heart rate was in good range.
65 2021-01-27 fainting, hypotension Immediately following vaccination, the patient became dizzy, weak, and suffered a syncopal episode. ... Read more
Immediately following vaccination, the patient became dizzy, weak, and suffered a syncopal episode. Blood pressure was noted as hypotensive at 70/60. IV fluids were administered by EMS and patient was transported to the Hospital emergency department for evaluation. After lying flat and receiving IV fluids, Patient's BP improved to 136/79 per triage note. Patient was discharged from the ED with vasovagal syncope and instructed to submit VAERS report.
65 2021-01-27 fainting Immediately following vaccination, the patient reported dizziness, weakness, and suffered a syncopal... Read more
Immediately following vaccination, the patient reported dizziness, weakness, and suffered a syncopal episode. EMS recorded the patient's blood pressure at 70/60 mmHg. EMS administered IV fluids while patient laid flat in transport to emergency department. BP had stabilized in triage 136/79. Discharged home after evaluation.
65 2021-01-27 heart rate increased my lower extremities went cold for an instant when they gave the vaccine but it quickly passed. Wait... Read more
my lower extremities went cold for an instant when they gave the vaccine but it quickly passed. Wait half an hour of post vaccination observation and it went well. On the return car the feeling of cold returned to me in my arms and legs. When I got home I felt good and I prepared something for lunch, when I started eating, around 3.30 pm (about an hour and a half after getting the vaccine) I started to feel bad, my heart was beating very strong and fast, I was gasping for air, dizzy. I used the oximeter and I saw that my heart rate was at 110 and kept going up and the oxygen was going down. I called 911 when the blood pressure monitor and oximeter reached the limit and started flashing, oxygen at 92 and pulses at 141. I thought I was dying. The 911 operator told me to lie down and wait for the paramedics and she stayed with me on the line. I also put ice on my chest. When they arrived my signs began to normalize. I can't quite remember what happened next that day.
65 2021-01-27 chest discomfort shortly after vaccine administered pt c/o tightness in chest. No other complaints. EMS was called an... Read more
shortly after vaccine administered pt c/o tightness in chest. No other complaints. EMS was called and patient was taken for further testing. no dizziness noted
65 2021-01-28 heart rate increased Heartbeats irregular/heart rate was all over the place/up to like a 101; This is a spontaneous repor... Read more
Heartbeats irregular/heart rate was all over the place/up to like a 101; This is a spontaneous report from two contactable consumers (patient self and patient's husband). This 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) on 15Jan2021 15:00 at single dose for COVID-19 immunisation, and received cetirizine hydrochloride (ZYRTEC, lot# 1663312, expiry date: Jan2022) from unspecified date at unknown dose for unknown indication. Medical history included allergic rhinitis, blood cholesterol abnormal. Concomitant medications included atorvastatin for cholesterol, fluticasone propionate (FLONASE) for allergic rhinitis. The patient received her first dose on Friday (15Jan2021), about 3 o' clock in the afternoon. And she was experiencing an irregular heartbeat from yesterday (16Jan2021). Reported that on 16Jan2021 morning, she woke up and heart rate was all over the place. She was in bed and it was up to like a 101 already. She had also taken cetirizine hydrochloride the night before. So, she didn't know if that's the problem also. No treatment received for the event. The action taken for cetirizine hydrochloride was unknown. Outcome of event was not recovered.
65 2021-01-28 pallor Patient vaccinated @ 10:14 on 1/29/2021 then placed in observation for 30mins. At 10:19 c/o dizzines... Read more
Patient vaccinated @ 10:14 on 1/29/2021 then placed in observation for 30mins. At 10:19 c/o dizziness, shortness of breath, nausea, shaking. patient is clammy & pale, a&o x4, lungs clear bil all lobes, pulse normal, cap refill <3, V/S @ 10:20, b/p 140/90, r22, p72, t 99.7, unable to obtain o2 stat via pulse ox r/t pt shaking. Patient states that temp normal runs 96.8. Monitoring pt while obtaining health history. 10:40 V/S t 99.8, b/p 160/74, p113, 02 88% on RA, r 24, o2 placed on pt 15l nonrebreather, o2 91%. 10:50 EMS arrived, pt a&ox4, no change in condition, V/S 100/60, 100% on 15L nonbreather, p90, r22. 10:55 still nausea, 4mg sublingual zofran given. 11:04 pt transferred to stretcher with assisit, a&Ox4, V/s 132/69, p80, 94% o2 on 10l via nasal cannula, r26 co2 33. pt transferred via ambulance, pt request to be taken to hospital.
65 2021-01-28 cerebrovascular accident Suffered a massive MCA stroke; This is a spontaneous report from a Contactable Nurse. A 65-year-old ... Read more
Suffered a massive MCA stroke; This is a spontaneous report from a Contactable Nurse. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included covid prior vaccination. Known allergies: None. The patient's concomitant medications were not reported. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right arm on 21Dec2020 03:00 PM at single dose for COVID-19 immunization. The patient was not pregnant while receiving vaccine. Facility type vaccine: Hospital. If other vaccine in four weeks: No. Other medications in two weeks: No. The patient suffered a massive MCA (Middle cerebral artery) stroke on 21Jan2021 08:00 after getting second covid vaccine with outcome of not recovered. No history of hypertension, elevated cholesterol or medical issues. No medication being taken. Daily BP (Blood pressure) reading normal. Covid test post vaccination: Nasal Swab-PCR on 22Jan2021 with result negative. If treatment for AE: Unknown. The event was resulted in: Emergency room/department or urgent care, Hospitalization (Number of days hospitalization: 4), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.; Sender's Comments: The event middle cerebral artery stroke appeared 8 days after administration BNT162B2. The Company considers that the event is less likely related to suspect BNT162B2 injection given the weak time association. The status (bleeding or infarction) and cause of the stroke would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-01-29 chest pain, heart rate increased, hypertension developed numbness/tingling of tongue, headache and also pain across chest, as well as high BP and H... Read more
developed numbness/tingling of tongue, headache and also pain across chest, as well as high BP and HR. Given water, benadryl 50 mg IM with improvement of everything except chest pain. Sent to CSMC ER for further evaluation.
65 2021-01-31 pallor Rash on face and neck starting within 10 minutes of vaccine. Swelling in cheeks and left neck, and t... Read more
Rash on face and neck starting within 10 minutes of vaccine. Swelling in cheeks and left neck, and tightness starting in left neck. Itching in the eyes.. Benadryl 50 mg po taken and pepcid 40 mg po taken at home. To emergency room within 1 hour after the vaccine due to tightening and swelling in the neck. They gave me Solumedrol IM and po zyrtec and observed me for awhile. Tightening in the neck eased up and I went home. By bedtime I turned pastey white color, no rash. In the morning I broke out in another rash on my face and neck. Rash resolved by the second day.
65 2021-02-01 fast heart rate, palpitations Client c/o flush that washed over her while waiting 15 minutes. Also stated tachycardia and "skippe... Read more
Client c/o flush that washed over her while waiting 15 minutes. Also stated tachycardia and "skipped heart beats." She stated that the skipped beats started about a week after her first dose of Pfizer. BP 128/82, pulse 88 with 1 skipped beat every 1-2 minutes by palpation. She refused EMS, went home in car after 50 minutes. At 4:15 p.m. called after another episode of flushing and tachycardia, feeling "weird." Went to urgent care and had EKG, normal compared to one 2 years ago. NP and a consulting doctor diagnosed vaccine reaction, advised fluids and rest. BP and pulse continue to fluctuate. Per client, 2/2/21 a.m. her pulse goes from 80-112. She will continue to monitor.
65 2021-02-01 blood glucose increased, hypotension, fast heart rate, haemoglobin decreased Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1... Read more
Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1/23 she had defervesed to normal temp. Afternoon of 1/23/21 temp 101.4, 1/24/21 fever of 103 and 101. On 1/25/21 the nurses called the doctor and said that she was lethargic. Dr. found her to be hypotensive, lethargic, tacchycardic, They sent her to the ER. She also had during that day they found her with neck pain with movement, chills and fever. From 1/25-today she is still admitted to the hospital. They found her to have staph aureus sepsis - source unknown, encephalopathy related to sepsis, they did rule out meningitis, hyponatremia, UTI with E-coli and some staph, urinary retention, rhabdomyalisis with acute kidney injury and dehydration. They are treating her with antibiotics, getting better but still hospitalized.
65 2021-02-02 blood pressure increased About 15 minutes after receiving Pfizer vaccine dose 1 IM LD, pt experienced itchiness and tightness... Read more
About 15 minutes after receiving Pfizer vaccine dose 1 IM LD, pt experienced itchiness and tightness of the throat and breathing difficulty. Pt immediately brought to nearby cots to lay down. BP 130/78, Pulse 92, O2 99. 5 minutes later BP increased to 142/86, Pulse 70, O2 99. Pt began to relax a bit but symptoms were unchanged and Epinephrine 0.3mg x1 given & EMS called. BP 10 minutes later 144/80, pulse 70 O2 99. EMS arrived 10 minutes later, BP 146/90, and brought to nearby hospital.
65 2021-02-02 palpitations Heart palpitations 45 minutes after shot , only lasted a few minutes, shortness or breath at random ... Read more
Heart palpitations 45 minutes after shot , only lasted a few minutes, shortness or breath at random times . First time 1&1/2 hours after injection without any asthma triggers, then 4-5 times lasted a few minutes each time during first 24 hrs, coughed more frequently, only used my rescue inhaler 3x during the first 48 hrs, fine rash on my face the next morning, lasted 48 hrs. I had body aches, chills , didn?t feel well for first 48 hours after the shot, ok now, just still tender at injection site, that is improving. Concerned I may have had a mild allergic reaction, worried about getting 2nd dose, but my doctor told me to take Benadryl prior to second dose & have someone drive me to the appointment, and get the second dose.
65 2021-02-03 fast heart rate Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a c... Read more
Blurred vision; fatigue; dizziness; tachycardia; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ 1685), via an unspecified route of administration in the left arm on 20Dec2020 08:00 at a single dose for covid-19 immunization. Medical history included prediabetes, spinal stenosis of right back, allergies in penicillin, sulfa and yellow jacket venom. Concomitant medication included gabapentin, metformin, paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc and vitamins. On 20Dec2020 20:00, 12 hours after vaccine administration, the patient experienced blurred vision, fatigue, dizziness, tachycardia and arm soreness. The patient did not receive treatment for the events. The patient had not tested positive for COVID post vaccination. The outcome of the events was recovered on unspecified date.
65 2021-02-04 arrhythmia Light headed and mild heart arrhythmia (fast beat). After 10 days, chills, joint pain and sore thro... Read more
Light headed and mild heart arrhythmia (fast beat). After 10 days, chills, joint pain and sore throat
65 2021-02-04 pulmonary embolism Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shor... Read more
Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shortness of breath with symptoms worsening as time went on. Pt remained afebrile. Pt presented to the ED and was diagnosed with a Pulmonary Embolism.
65 2021-02-04 blood pressure increased fever, headache, bp 155/79 (usdually in 110's 120's/ baseline), and nausea. Caller wanted to know i... Read more
fever, headache, bp 155/79 (usdually in 110's 120's/ baseline), and nausea. Caller wanted to know if any interaction with APAP. Advised no interaction between Pfizer covid Vaccine and APAP, increase fluid intake as well, PIC will call back to f/u at later time.
65 2021-02-05 heart rate increased Client complaining of increase heart rate P112 and is taking metoprolol. EMS evaluated and client P ... Read more
Client complaining of increase heart rate P112 and is taking metoprolol. EMS evaluated and client P came down after breathing exercises and relaxing.
65 2021-02-05 loss of consciousness Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection giv... Read more
Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection given and a wave of pain and nausea and malaise overwhelmed me. I passed completely out still lying in bed (so out that I wet myself in bed) and gradually came to, still feeling horrible. Got up, changed clothes, and major chills when I returned to bed. Around 6am I felt nauseous, got up to vomit, but instead passed completely out on the bathroom floor for about 15 minutes. Remainder of day I felt very stiff, low energy and slightly woozy. By afternoon, energy was returning (I vacuumed the house). Minimal pain in arm this time compared to previous.
65 2021-02-07 blood glucose increased HA over R-eye, dizzy, shaky, no breakfast, no BS check., BS @ 14:18: 294
65 2021-02-08 chest discomfort FELT TOTALLY FINE AFTER INJECTION AND WALKING TO OBSERVATION ROOM. HAD BEEN SITTING THERE FOR ABOUT... Read more
FELT TOTALLY FINE AFTER INJECTION AND WALKING TO OBSERVATION ROOM. HAD BEEN SITTING THERE FOR ABOUT 4 OR 5 MINUTES SO HAPPY IT WAS OVER AND WE WOULD BE LEAVING SOON. THEN SUDDENLY AN INDESCRIBABLE SENSATION HIT ME LIKE A BRICK. I FELT AS IF I LOST MY SENSE OF REALITY. MAYBE AKIN TO ONE BEGINNING TO FAINT. CANNOT DESCRIBE IT ? VISION AND HEARING AFFECTED SUDDENLY ? LIKE THINGS CLOSING IN ON ME. THEN FELT A SENSATION IN MY CHEST AROUND BOTH LUNG AREAS WHICH TRAVELED UP MY NECK. I SAT DEBATING WITH MYSELF WHETHER TO MAKE A SCENE AND CALL FOR HELP VERSUS TELLING MYSELF IT WOULD BE OKAY. IT TOOK ABOUT 7 MINUTES BEFORE I COULD RELAX AND NOT BE TERRIFIED OF WHAT JUST HAD HAPPENED TO ME. I NOTICED A SCRATCHY SENSATION ON THE BACK OF MY TONGUE. GLAD HUSBAND WAS DRIVING BECAUSE I WAS SLIGHTLY DIZZY FOR SEVERAL HOURS. IT WAS TERRIFYING AND I DO NOT WANT TO GET INJECTION #2.
65 2021-02-08 lightheadedness Pfizer BioNTech COVID 19 Vaccine EUA - After waiting the 15 minute observation time in our clinic, p... Read more
Pfizer BioNTech COVID 19 Vaccine EUA - After waiting the 15 minute observation time in our clinic, patient proceeded to car. Patient became dizzy, got out of car and returned to clinic. Provider assessed patient as a vasovagal reaction. AFter 30 min additional observation time, symptoms resolved and patient was discharged to home.
65 2021-02-08 loss of consciousness She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energ... Read more
She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
65 2021-02-08 blood pressure fluctuation The patient had a headache within 5 minutes of receiving the vaccine. The patient was monitored and... Read more
The patient had a headache within 5 minutes of receiving the vaccine. The patient was monitored and her blood pressure taken three times, 5 minutes apart; the readings were 95/65 SBP/DBP, then 106/64, and finally 93/67. The patient was counseled by a pharmacist that since her headache was not severe she was able to leave if she wanted to. She did leave and upon follow up 6 hours later, the patient reported taking over the counter Tylenol to treat the headache that still persisted. The patient was asked to please report back to the pharmacy if the headache persists to tomorrow.
65 2021-02-08 pulmonary embolism, fainting my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like ... Read more
my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like a deep wide black spot and it is hard; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included amlodipine, metformin and propranolol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization and experienced severe headache and diarrhea. On 13Jan2021, the patient reported that: "my body collapsed, I had a pulmonary embolism. I had to go to the hospital in ambulance. When I was there, they find out that I have clot in my lung. I was in an intensive care for 2 days or 3 days and about 5 days in the hospital (from 13Jan2021 to 17Jan2021). I have behind my knee like a deep wide black spot and it is hard, my body did not have anything like that". Therapeutic measures were taken as a result of event pulmonary embolism/ clot in lung and included treatment with "some medications", one of which ELIQUIS. The patient outcome of pulmonary embolism and "clot in lung" was recovered on an unspecified date and of deep wide black spot was unknown. The information on the batch number has been requested.
65 2021-02-09 heart rate increased, blood pressure increased Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155... Read more
Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155/94; pulse rate up; This is a spontaneous report received from a contactable consumer (the patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL 9261), via an unspecified route of administration in the left arm on 21Jan2021 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, indoor and outdoor allergies, and allergies to latex and contrast. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously took and had allergies to: amoxicillin/ clavulanic acid (AUGMENTIN), sulfamethoxazole/ trimethoprim (BACTRIM), levofloxacin (LEVAQUIN), and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Within 5 minutes of receiving the dose on 21Jan2021, at 15:45 (as reported), the patient's face and chest became bright red, felt very hot, sinus pressure increased. The EMT's took her blood pressure- was up 155/94, and her pulse rate was up (21Jan2021, 15:45 (as reported)). Her temperature and blood sugar were within normal limits (21Jan2021). The patient did not receive any treatment for the events. The clinical outcome of face and chest became bright red, felt very hot, sinus pressure increased, blood pressure was up 155/94, and pulse rate up was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
65 2021-02-09 chest discomfort eyeballs, eyelids swollen, then face swollen and blotched, then second layer of skin became scalding... Read more
eyeballs, eyelids swollen, then face swollen and blotched, then second layer of skin became scalding on fire hot but no temp. then whole face and ears swollen. then swelling and blotch moved down into neck and upper chest. had been having trouble breathing from beginning of symptoms was getting worse.
65 2021-02-12 chest discomfort, low blood oxigenation chest tightness and difficulty breathing since receiving vaccine, found to be hypoxic in hospital
65 2021-02-15 chest pain Had chest pain, difficulty breathing approximately 30 minutes after shot. Also sharp pain left fore... Read more
Had chest pain, difficulty breathing approximately 30 minutes after shot. Also sharp pain left forehead. Lasting approximately 15-20 minutes.
65 2021-02-17 hypertension, heart rate irregular trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feelin... Read more
trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feeling very shaky and very weak; feeling unwell; alternating slow heartbeat and fast heartbeat; a weird feeling in her head like pressure but not a headache/pressure feeling in my head; they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction.; This is a spontaneous report from a contactable consumer. A 65 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 31Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included allergic to shrimp, lupus anticoagulant syndrome, chronic kidney disease and antiphospholipid syndrome. Concomitant medications included amlodipine, HCTZ, losartan, acetylsalicylic acid (ASPIRIN (E.C.) and atorvastatin calcium (LIPITOR ORIFARM). The patient informed that immediately after receiving the injection she felt a lump in her throat and could not swallow, still present now. Patient also informed that after vaccination she was having a very high blood pressures, feeling very shaky and very weak, a weird feeling in her head like pressure but not a headache, trouble sleeping because of the pressure feeling in my head, feeling unwell and alternating slow heartbeat and fast heartbeat. Patient also reported she had scheduled an allergist appointment and they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction. At the time of the reporting event outcome was unknown.
65 2021-02-18 heart rate irregular, pulmonary embolism, atrial fibrillation, heart attack Patient developed shortness of breath and irregular heart beat 8 days after receiving immunization. ... Read more
Patient developed shortness of breath and irregular heart beat 8 days after receiving immunization. Presented to the Clinic and was sent to the Emergency Department for evaluation. Admitted for PE, NSTEMI, and afib with RVR 2/11/21. Discharged to home 2/12/21.
65 2021-02-21 loss of consciousness Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and... Read more
Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and got up to go to the bathroom but felt fine. Went out to the hall bathroom so as not to wake husband in Master bath. Urinited and got up slowly as I always do and walked out to the hallway to go back to bed. I lost consciousness and came to when my husband who heard a thud came and found me out having fallen down the stairs.. head on the landing and feet above the landing. I have no recollection of it once leaving the bathroom and i would have headed away from the stairs which was just to the left of the bathroom doorway. I didn't feel any pain. Later found a bump on my forehead of the right side of my face and a bruised lip. He said my back was wet with sweat and I took a couple minutes to come to. After returning to the bed.. i immediately had to empty bowels. Diarrhea.. then the rest of the night in Chills. No fever. Slept most of the next day and night. Headache and joint aches and swelled lymph nodes in neck.. Fatigue through 20th. Mostly better by the 21st. Still today on 22 I am being careful when going from prone to standing. I feel more head pressure getting up and maybe I notice a little nausea when rising. I may just be worried about fainting again. It has never happened to me before. I do have very good blood pressure on the lower side so I was always careful to get up slowly but never fainted. Neck is sore.. Not sure if lymph nodes or something to do with fall.
65 2021-02-21 chest pain I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over a... Read more
I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over all my body (joint/muscle pain) that started about 10 PM the night. I woke up Saturday morning with a bad headache, felt like I was pass out, I had chills. Saturday afternoon I noticed under right armpit the lymph nodes were swollen. The pain radiates throughout my chest and shoulder but most severe under the armpit. As of today 22nd I feel tired and I am still experiencing the swollen lymph nodes under my right arm pit. All the other symptoms have went away. The lymph node feels warm to touch, there is also a small area of redness around the injection site. I am still having post COVID-19 symptoms as well which include nasal issues, weakness and brain fog. I have had all these symptoms since November.
65 2021-02-21 cerebrovascular accident Stroke in third branch of middle cerebral artery and intramural clot of right carotid artery
65 2021-02-21 chest discomfort tongue swollen, throat felt "thick, heaviness in chest, palms of hands felt hot and tingly, started ... Read more
tongue swollen, throat felt "thick, heaviness in chest, palms of hands felt hot and tingly, started as we were leaving the vaccination location outside the hospital about 10 minutes after the shot. No treatment.
65 2021-02-22 ischemic chest pain I experienced angina lasting ~ 15-20 seconds. I've never experienced anything like this and have no... Read more
I experienced angina lasting ~ 15-20 seconds. I've never experienced anything like this and have no cardiac illness or involvement. I was at work and just stood there until it passed. It felt like someone was squeezing my chest from front and back very hard, would categorize pain as about 7 or 8 out of 10. I hadn't eaten anything that morning and only a few sips of black coffee 4 hrs prior. Could this have been a reaction to the covid vaccine?
65 2021-02-23 palpitations 5:00 pm 2/23 headache/ fatigue 1:30 am 2/24 chills, headache, racing heart, shortness of breath, low... Read more
5:00 pm 2/23 headache/ fatigue 1:30 am 2/24 chills, headache, racing heart, shortness of breath, low grade fever , aches
65 2021-02-23 hypertension Almost immediate nausea, light headed, elevated blood pressure, arm pain
65 2021-02-23 palpitations pfizer jan 29 pfizer feb 19 Pfizer #1 EL 9263 Pfizer #2 EL 9267 low grade fever of 99.0, palpitatio... Read more
pfizer jan 29 pfizer feb 19 Pfizer #1 EL 9263 Pfizer #2 EL 9267 low grade fever of 99.0, palpitations, and diarrhea yesterday. Recommended that she see her primary provider if symptoms worsen.
65 2021-02-24 chest discomfort Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired... Read more
Headache, tightness in chest, legs hurting from my knees down, hard to focus vision, and super tired. started about an hour later. Did not sleep well. Stayed in bed the next 2 days. Tightness in chest went away the second day. Third day I felt like myself. These were things that I also experienced with Covid.
65 2021-02-24 increased heart rate, hypertension, hypotension, lightheadedness Within 15-minutes of vaccination, the patient reported feeling flush, near-syncopal, dizzy, and ligh... Read more
Within 15-minutes of vaccination, the patient reported feeling flush, near-syncopal, dizzy, and lightheaded with diaphoresis. EMS evaluated patient on-site. Patient was hypotensive (89/60). 12-lead EKG showed sinus tachycardia, rate 102 bpm, no ST elevation. EMS transported the patient to Emergency Department for further evaluation. In ED, patient was hypertensive (155/65) with all other vitals WNL. Repeat EKG indicated NSR, low voltage QRS, with no ischemic appearing ST changes. ED physician administered 1L saline bolus and 650mg Acetaminophen. Patient reported feeling better and was discharged with a differential diagnosis of vasovagal episode, electrolyte imbalance, and volume depletion.
65 2021-02-25 deep vein blood clot Diagnosed with May-thurner syndrome; Deep vein thrombosis; Both of her feet were only slightly swoll... Read more
Diagnosed with May-thurner syndrome; Deep vein thrombosis; Both of her feet were only slightly swollen; Dull minor headache; Off-label use; Inappropriate schedule of vaccine administered; Localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (weight: 77.56 kg, height: 157 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the upper left arm, on 23Jan2021, for COVID-19 immunisation. Relevant medical history included thyroid condition from an unspecified date (over 25-30 years before this report) and ongoing, controlled with levothyroxine sodium (SYNTHROID); and breast cancer from an unspecified date, in 2019 (treatment and surgery on an unspecified date, in 2019. Presumed resolved with radiation treatment, but no treatment within a year prior to getting Pfizer COVID-19 vaccine). The patient previously, on 05Jan2021 (18 days before the second dose), received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunisation. After the first dose, the patient experienced localized discomfort at the injection site and swelling of feet. Concomitant medication included levothyroxine sodium (SYNTHROID) from an unspecified date and ongoing, 0.88 mg, daily, for thyroid condition. On 23Jan2021, the patient experienced injection site discomfort described as "localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given". On 24Jan2021, she had dull minor headache. On an unspecified date, the patient was hospitalized after the second dose and was diagnosed with May-thurner syndrome. She clarified that May-Thurner syndrome was where the iliac artery collapses and crushed the iliac vein in the upper abdomen; from that point down it started creating a blood clot. She developed a deep vein thrombosis (DVT) from her left ankle up to her right rib cage area; it was a monster. On 10Feb2021, the patient experienced deep vein thrombosis and thrombectomy was performed on the same day (outpatient thrombectomy surgery, performed 10Feb2021. It was a great surgery, very corrective. She never did have any pain or discomfort which confused everyone. She felt fine this whole time, no issues). On an unspecified date, both of her feet were only slightly swollen. Relevant laboratory test, performed on an unspecified date, in 2021, included computerised tomogram (CT scan with contrast of her abdomen and chest) that showed deep vein thrombosis: left ankle-right ribcage area. The adverse events May-Thurner syndrome and deep vein thrombosis were assessed as serious, hospitalization required from 02Feb2021 to 10Feb2021. The patient recovered from deep vein thrombosis on 10Feb2021, recovered from headache on 26Jan2021, recovered from swelling of feet and vaccination site discomfort on an unspecified date, while clinical outcome of the other events was unknown. Her vascular surgeon said he did not believe these events were vaccine related but cannot rule it out; her Primary Care Physician absolutely believed the events were vaccine related. The information on the lot number has been requested.
65 2021-02-25 excessive bleeding Starting at bedtime, the patient felt itchiness at the injection site. The sensation started to feel... Read more
Starting at bedtime, the patient felt itchiness at the injection site. The sensation started to feel so intense that it felt like her skin was crawling. Shortly after she developed a rash and with raised, red pustules. The scratching led to bleeding and eruption of the pustules. The sensation went away after a few hours and left small scabs that are now healing.
65 2021-02-25 cerebrovascular accident blew a blood vessel under her eye lid; stroke; tasted rubber band taste in her mouth; This is a spon... Read more
blew a blood vessel under her eye lid; stroke; tasted rubber band taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), in a clinic, intramuscularly in the right arm on 29Jan2021 at 14:00 at 65-years-old at a single dose for COVID-19 immunization. There were no prior vaccinations within four weeks of the bnt162b2. Medical history included ongoing fibromyalgia from an unknown date, reflex sympathetic dystrophy from an unknown date and unknown if ongoing, irregular heart beat from an unknown date and unknown if ongoing, ongoing hemangioma from an unknown date, thyroid problems from an unknown date and unknown if ongoing, low white blood cell counts from an unknown date and unknown if ongoing, ongoing pinched nerves in her neck and back from an unknown date, migraines from an unknown date and unknown if ongoing, diastolic heart failure from an unknown date and unknown if ongoing (diagnosed about 5 years ago.), abdominal pains from an unknown date and unknown if ongoing, numbness in her nose, foot from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing, vomiting from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1283) for COVID-19 immunization on 08Jan2021 at 64-years-old and experienced metallic taste (Recovered), carbamazepine (TEGRETOL) from an unknown date to an unknown date and experienced white count was down to 1, influenza vaccine (MANUFACTURER UNKNOWN) in Jul2020 at 64-years-old for immunization. The patient experienced the following events and outcomes: stroke (medically significant) on 29Jan2021 at 14:10 with outcome of unknown, blew a blood vessel under her eye lid (medically significant) on 31Jan2021 with outcome of recovering, tasted rubber band taste in her mouth (non-serious) on 29Jan2021 with outcome of unknown. The clinical course was reported as follows: The patient reported a history of migraines/ weather migraines, that cause numbness in nose and foot as well as gastro-intestinal symptoms. The patient received her first dose of the Pfizer COVID vaccine on 08Jan2021 and felt a metallic taste in her mouth (said that the metallic taste lasted about three hours; ate to get rid of the metallic taste). On 29Jan2021, the patient received her second dose; after 10 minutes her face went numb; her nose, forehead, and under her eyes all the way up felt numb. Also, the patient's systolic blood pressure was at 150. The patient reported that she also tasted rubber band taste in her mouth. The patient's neighbor that was there with her getting the vaccine told the nurse and they called the paramedics. The paramedics stated that they thought she had a stroke. She said that her blood pressure was 150 systolic (usually 107-110/79). The patient had diastolic heart failure which was diagnosed about 5 years prior. The numbness stayed with her until about 22:00 on 29Jan2021. The patient had a history of "migraines and gets abdominal pains, numbness in her nose, foot", and she experienced "nausea and vomiting and stuff with her migraines." The patient thought the vaccine just gave her a big migraine. The patient took sumatriptan succinate (IMITREX) and it did nothing. The patient said that on 31Jan2021 her eye felt weird. The patient blew a blood vessel under her eye lid. The patient's eye looked like a blood clot in the corner of her eye then it dispersed throughout the eye and then now it was just below the pupil of her eye. The patient called the doctor on 01Feb2021, but they were out because of the snow. On 02Feb2021, the patient received a call from the doctor's office saying that the physician assistant would call her back, but the patient had not heard anything yet. The blood circulated around her eye and now it was just only under her pupil. The patient said that her daughter sent her something that said that some people have gotten Bell's palsy after getting the vaccine. The patient said that she was concerned about this with the facial numbness. The patient said that every once in a while, her face felt weird; her cheeks feel weird and her nose. The patient said that it comes and goes. The day after she got the second shot, she felt like she got run over by a truck and like someone beat her up. The patient's migraines were under control with magnesium. The migraine came on so quick it was like a boom. The patient said that was why she was concerned. The patient said that she declined going to the hospital; and there was no trip to the emergency room or physician office. The patient underwent lab tests and procedures which included blood pressure: 150 systolic on 29Jan2021 (usually 107-110/79). Therapeutic measures were taken as a result of stroke.
65 2021-02-28 loss of consciousness 15 minutes after her dose, patient was leaving and fell to the floor. She was unconscious briefly a... Read more
15 minutes after her dose, patient was leaving and fell to the floor. She was unconscious briefly and woke up within a couple of seconds. She was breathing heavy and 911 was called. She stayed on the ground for about 10 minutes and refused treatment. She kept asking not to start any IVs on her. Patient eventually recovered and refused the ambulance. Follow up call to her house later that day indicated she was doing fine and did not need any further treatments.
65 2021-02-28 chest discomfort Client c/o chest tightness. Client states I am having a hard time breathing. Client seen by EMS. ... Read more
Client c/o chest tightness. Client states I am having a hard time breathing. Client seen by EMS. Vitals: B/P 133/85, HR 88, Client verbalized that she had been anxious about receiving vaccine and that she is now able to breathe now that it's over and was cleared to go home by EMS.
65 2021-02-28 chest discomfort Difficulty swallowing, chest discomfort severe about 6 hrs day of vaccine lingering difficulties t... Read more
Difficulty swallowing, chest discomfort severe about 6 hrs day of vaccine lingering difficulties throught 3 days .continued . saw dr. march 1st soft foods for now
65 2021-02-28 atrial fibrillation I have been diagnosed with Afib but do not have daily episodes. Within 2 hours after receiving the ... Read more
I have been diagnosed with Afib but do not have daily episodes. Within 2 hours after receiving the vaccine I began to have regular episodes throughout the day and night and they have continued.; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELB982), via an unspecified route of administration on the left arm on 25Jan2021 11:15 at a single dose for COVID-19 immunization. Medical history included heart disease, hypothyroidism and Afib (Atrial fibrillation). The patient is not pregnant. Concomitant medication included levothyroxine, acetylsalicylic acid (BABY ASPIRIN) and cetirizine hydrochloride (ZYRTEC). It was reported that the patient was diagnosed with Afib but do not have daily episodes. Within 2 hours after receiving the vaccine (25Jan2021 13:30), the patient began to have regular episodes throughout the day and night and they have continued. Her cardiologist is out of town and was referred by his office to go to the ER if she felt she should. The patient do not think it is bad enough to go to the ER so she is just monitoring on her Apple Watch. No treatment was received for the event. The outcome of the event was not recovered.
65 2021-02-28 heart flutter Pt. left tent 9 to observation and started feeling lightheaded and heart fluttering. Paramedics ass... Read more
Pt. left tent 9 to observation and started feeling lightheaded and heart fluttering. Paramedics assessed EKG (PAC) on monito, It subsided once patient relaxed. Paramedics cleared pt. and let her leave,
65 2021-03-01 platelet count decreased, oxygen saturation decreased, blood glucose increased, cardiac failure congestive 2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the or... Read more
2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the original. NURSING HOME ACUTE VISIT 6/24/1955 MD SUBJECTIVE: Chief Complaint Patient presents with ? Cough Pt has COVID 19 and she is coughing and congestion. This is an acute visit with pt. Status and changes discussed with staff. Advanced directives on file. Allergies reviewed at NH, though may not be fully updated in electronic record. Problem List reviewed. ROS: Gen: Denies fever CV: Denies chest pain Resp: Denies dyspnea GI: Denies abdominal pain. GU: Denies dysuria. Psych: Denies depression. OBJECTIVE: VITALS: Vitals: 02/03/21 1226 BP: (!) 94/54 Pulse: 79 Resp: 18 Temp: 37 °C (98.6 °F) SpO2: 96% PHYSICAL EXAM: General: Alert, awake, no acute distress Skin: Intact HEENT: Grossly normal Neck: Supple Lungs: Within normal limits/clear CV: RRR Abdomen: Soft, BS active Extr: WNL Neuro: Unchanged and nonfocal ASSESSMENT/PLAN: Reviewed and signed orders. Recheck in 60 days. Patient was seen today for cough. Diagnoses and all orders for this visit: COVID-19 Cough CXR 2 view. Plan to start melatonin, vit D3, zinc. Rehab nurse note: Table of Contents for Miscellaneous Notes Telephone Encounter - RN - 02/09/2021 9:30 AM CST Telephone Encounter - 02/09/2021 9:16 AM CST Telephone Encounter - RN - 02/09/2021 9:30 AM CST Discussed with Dr. and he recommended that patient go to ER for urgent evaluation/treatment with dyspnea and low O2 levels even with supplemental oxygen. Electronically signed by RN at 02/09/2021 9:32 AM CST Back to top of Miscellaneous Notes Telephone Encounter - 02/09/2021 9:16 AM CST Rehab called, they stated PT was having trouble breathing and her O2 was 80 with oxygen. They wanted to know if they should bring her in but PT is Covid positive. Staff recommended that she go to the ER. Electronically signed at 02/09/2021 9:17 AM CST 2/9 ER-> admission note: (6day admission) History The patient is a 65 y.o. female with a past medical history notable for History of anemia, anxiety, cirrhosis, COPD, CHF, diabetes, reflux, hypertension. The patient presents for evaluation of Worsening issues of cellulitis in addition to the patient's history of recent Covid 19 infection. Patient also tested positive for influenza. Patient was started on steroids at skilled care facility. Patient was already on breathing medications. Patient has had issues with CHF and lower extremity swelling. Patient was taking a diuretic for this. Due to patient's cerebral kidney function patient is not a candidate for certain medications or either influenza, Covid 19 and we are limited on antibiotics. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/1/21 er to admission note: currently inpatient History The patient is a 65 y.o. female presents for evaluation of altered mental status. Notable PMHx: CHF, morbid obesity, diabetes, Patient is 3 weeks out from hospitalization for COVID-19 pneumonia. She has been more confused over the couple of days before admission. Because of altered mental status, patient was transferred to the emergency room. Patient also had some shortness of breath. In the ER, she had a chest x-ray which showed moderate interstitial infiltrate secondary to pulmonary edema or pneumonia. Lab work did show a UTI. BNP was normal at 45. Creatinine was near her baseline at 1.8. She did have elevated alkaline phosphatase at 452. White count was elevated at 14.7. Patient was difficult to arouse in the ER. On my exam, patient is difficult to arouse. After shaking her shoulder and yelling at her, she did open her eyes and say to me "I'm ok" before closing her eyes again. She is satting well on nasal canula oxygen.
65 2021-03-01 fainting Fever 100 - 101.5 24+ hours Chills 3.5 hours at noon 2-28, dizziness, nausea 2-3 hours one episode s... Read more
Fever 100 - 101.5 24+ hours Chills 3.5 hours at noon 2-28, dizziness, nausea 2-3 hours one episode syncope with fall, no injury extreme lassitude 24 hours
65 2021-03-01 chest discomfort Patient received the first dose of the Pfizer COVID-19 vaccine and subsequently developed hives on h... Read more
Patient received the first dose of the Pfizer COVID-19 vaccine and subsequently developed hives on her mouth, neck, and chest. Associated with mild chest discomfort and throat swelling, but not with shortness of breath. Patient was given epinephrine and Benadryl by medics and pharmacist on scene. Patient took Benadryl 25mg prior to vaccine. Patient was given Solu-medrol and Pepcid in ED. Normal EKG and no further allergic reaction noted.
65 2021-03-02 hypertension Elevated blood pressure, Encephalopathy, Lumbago, Transient global amnesia
65 2021-03-02 palpitations Patient reported that her heart is racing. I checked her BP three times: 12:37pm 168/98 pulse 97 12... Read more
Patient reported that her heart is racing. I checked her BP three times: 12:37pm 168/98 pulse 97 12:46pm 157/96 pulse 89 12:58pm 147/93 pulse 86 Patient said she felt anxious due to her allergy history. I had her sit in the observation area for 30 minutes and gave her water. She displayed no additional symptoms and nothing that would have been indicative of anaphylaxis. She was vaccinated at 12:30pm and left the store with her husband at 1pm.
65 2021-03-02 loss of consciousness Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, sta... Read more
Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, started going downhill with chills and some sneezing. Managed to get to sleep, but woke up at 1:15 am and could not get back to sleep. Feeling chilled all night. At 5:30 am, got out of bed to take Tylenol and experienced dizziness (briefly blacked-out), sweats, nausea (vomited) and slight diarrhea. After that episode, started to feel a little better, though still a bit woozy and exhausted from lack of sleep.
65 2021-03-02 blood pressure increased blood pressure is "off the charts" (in her words) after taking Pfizer. it is 197/96 and it is normal... Read more
blood pressure is "off the charts" (in her words) after taking Pfizer. it is 197/96 and it is normally 127/79.
65 2021-03-02 chest pain chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas... Read more
chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas of dermal filler, which was administered 10/2019 and progressed throughout face; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200, expiry date unknown) via an unspecified route of administration on 13Feb2021 13:15 in left arm at single dose for COVID-19 immunization. Medical history included migraine, joint pain and dermal filler in Oct2019; allergies to penicillin, mango, tree nuts, bees, shrimp. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication received within 2 weeks of vaccination included estrogens conjugated (PREMARIN), celecoxib (CELEBREX), levothyroxine, colecalciferol (D3), cyanocobalamin (B12), ascorbic acid (C) and Mul. The patient previously received first dose of BNT162B2 (lot number EL9262), on 23Jan2021 09:30 AM at Left arm. At 4:30 am 14Feb2021, the patient woke with chest pain, dizziness, joint and muscle pain; and bad headache. Extreme facial swelling began in areas of dermal filler, which was administered Oct2019 and progressed throughout face. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl and Tylenol (today 1 Celebrex). The outcome of the events was recovering. The events were reported as non-serious, did not result in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating, congenital anomaly or birth defect
65 2021-03-03 blood pressure increased, fast heart rate Pt had a hypersensitivity reaction to her COVID 19 vaccine. Her symptoms included becoming flush and... Read more
Pt had a hypersensitivity reaction to her COVID 19 vaccine. Her symptoms included becoming flush and tachycardic. Her BP was elevated initially (209/117). She did endorse forgetting to take her BP medications this AM and failing to eat anything for breakfast. A medical response was called and the patient received 10 mg of Zyrtec po. An EKG was obtained and read as normal by the responding provider. The patient was observed for a period of 90 minutes until her symptoms resolved and her BP and HR improved. She also had a snack and drink.
65 2021-03-03 fast heart rate Tachycardia, throat "feels funny" - Evaluated by EMS-Cleared
65 2021-03-04 fainting Syncope, roused after roughly 4 minutes. Patient seen by MD, had juice, observed for 30 minutes, ex... Read more
Syncope, roused after roughly 4 minutes. Patient seen by MD, had juice, observed for 30 minutes, experienced dizziness, see again by MD, eventually DC to home @1100 with significant other.
65 2021-03-05 heart flutter 1) 25 minutes from injection: fluttering heartbeat, hot flush spreading from arm throughout body, we... Read more
1) 25 minutes from injection: fluttering heartbeat, hot flush spreading from arm throughout body, weakness in arm and then all over, shaking, dry mouth and tongue. The worst of it lasted about 5 minutes but weakness and shaking continued for about an hour. 2) Over the course of several hours developed sore arm and headache which worsened over the next 12 hours but was not terribly bad. 3) Days 3-6 had stiffness which began at injection site and went up left shoulder into the left side of neck. Resolved by day 7. 4) ON DAY EIGHT I developed a rash and itching at the injection site. Also had a dry cough and sinus drainage but cannot be certain this was from the vaccination but the rash and itching definitely was. The rash resolved by day 12. It was not terribly bad and no drugs were needed to calm the itch.
65 2021-03-05 heart rate increased Dizziness, tingling tongue, elevated HR, evaluated by EMS-cleared.
65 2021-03-05 nosebleed Temporary nosebleed --Unusual occurrence
65 2021-03-06 heart rate increased Within a minute or two my heart started beating fast and hard and a headache began in my forehead. I... Read more
Within a minute or two my heart started beating fast and hard and a headache began in my forehead. I took off my mask, rolled down the window. This helped and it subsided within the 15 minute wait when we left the vaccination site. My head continued to feel a little woozy and the hard fast heartbeat returned with the headache three more times throughout the day with last one around 5:30pm. Next day just felt washed out.
65 2021-03-07 cerebral haemorrhage, hypertension High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these hap... Read more
High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these happened around 9:00 p.m. As soon as those signs appeared we rushed her to the ER. The results showed Brain bleed. She was transfered to Hospital where she was valorated again and other series of test were performed. On Tuesday, 02/16/2021 she was discharged from the hospital with Discharge Diagnoses: //Bilateral subarachnoid hemorrhage //Intractable headache //Essential hypertension, uncontrolled//Generalized anxiety disorder. Thursday 03/04/2021 we follow up with the neurologist. Saturday 03/06/2021 she went to the ER with blood preasure of 189/83.
65 2021-03-08 transient ischaemic attack, cerebrovascular accident TIA followed by mild stroke 10 hours later. Hospitalized for 2 days for tests and observation.
65 2021-03-09 blood pressure increased First my bp my who life has been 130/80 I first noticed I was feeling very flushed, didn?t make much... Read more
First my bp my who life has been 130/80 I first noticed I was feeling very flushed, didn?t make much of it. I don?t take my bp,often, dr offices etc. 4 weeks ago, I felt pressure around eyes, in back of neck, weak, dizzy. My bp had spiked to 203/104, my husband called the ambulance. I went to ER. Bp went down, I came home, same thing happened the next day. Back in again.... Since then, I have had just about every test possible. I am perfectly healthy on paper. I just don?t know what to,do.... have now taken some bp meds and beta blocker. I can feel my bp spiking several times a day. 170/93 and then after a while back down again. I feel like I might be allergic to whatever is in my body. My hands and face tingle, I feel hot and then cold. I am praying this will ease it way out after the vaccine wears off. Needless to,say I am super concerned. I have ALWAYs been very healthy, fit and happy with a busy life.
65 2021-03-09 hypertension, heart rate increased On or about March 5th or 6th I started noticing my heart was beating rapidly and my blood pressure ... Read more
On or about March 5th or 6th I started noticing my heart was beating rapidly and my blood pressure was higher. Mostly at night but it happened again this morning. Feeling like I might get a headache but don?t get one. Started thinking it might be a reaction to the shot. Unsure whether to get second dose .
65 2021-03-09 blood pressure increased Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 3/3/2021 Subjective Pt. is a 65 y.o... Read more
Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 3/3/2021 Subjective Pt. is a 65 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience throat tightness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress and tongue swelling. Past Medical History: Diagnosis Date ? Belching ? Bloating ? Chicken pox ? Cold sensation of skin ? Diarrhea ? Ear pain ? Generalized headaches ? German measles ? Graves disease ? Measles ? Mumps ? PVC (premature ventricular contraction) ? Sinusitis ? Thyrotoxicosis without mention of goiter or other cause, without mention of thyrotoxic crisis or storm Hyperthyroidism; ? Type II or unspecified type diabetes mellitus with unspecified complication, not stated as uncontrolled (HCC) DM Type II with comp; ? Unspecified essential hypertension Hypertension; ? Varicella without mention of complication Chicken Pox; ALLERGY REVIEW OF SYSTEMS: Patient complains of sore throat, frequent throat clearing and headaches (states she was outside yesterday and developed a headache/sinus headache. She has not taken anything for it.) Patient denies chills, fever and malaise/fatigue Previous Reactions: hx of reaction to tetanus. Reaction was arm swelling and throat swelling per pt. She did not take any medications I.e. anti-histamines prior to coming. She has throat clearing, states this is chronic, unchanged. She reports that she isn't sure if this is allergic or anxiety. Objective Vitals Vitals: 03/03/21 0940 03/03/21 0945 BP: (!) 190/71 (!) 167/76 Pulse: 86 SpO2: 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious (slightly anxious). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water pepcid and zyrtec Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash). HTN More likely anxiety related in her reaction today. No progression of her symptoms of throat tightness. She reports it is resolving. Time of observation was 30 minutes. She feels comfortable going home. She is aware of what to monitor for. IN regards to her elevated bp, pt states she was off her medications for a while and working on diet. She is stable w/o cp, sob, jaw pain, neuro deficits, lightheadedness, dizziness. Recommend she monitor her bp at home and if continues to be elevated >140/90 that she follow up with her pcp. She also is aware of hypertensive emergency and to go to ED if needed. She is stable and looks well on discharge. Pt is comfortable going home. She ambulated w/o difficulty and complaints. Pt also was offered tylenol here in the bay for her sinus headache that she developed yesterday after being outside. She declined. She reports she will take at home and resume her nasacort as usual. Electronically Signed 3/3/2021 9:50 AM 3 of 3
65 2021-03-09 chest discomfort shortness of breath, chest pressure, fatigue
65 2021-03-10 chest discomfort, blood pressure increased 10:16 am - Client complained of blurry vision and chest pressure and increased blood pressure after ... Read more
10:16 am - Client complained of blurry vision and chest pressure and increased blood pressure after 15 minutes after receiving the vaccine. Client was evaluated by MD onsite at the Mini POD and EMS. Client was transported by EMS to Hospital. Did a follow up call found out client was only in the Emergency Room and then was discharged with no medication. Advised client to monitor blood pressure and follow up appointment with MD if need to start Blood pressure medications.
65 2021-03-10 blood pressure increased Patient had history of anxiety with previous vaccines, started to become anxious when she though she... Read more
Patient had history of anxiety with previous vaccines, started to become anxious when she though she lost her vaccine card. Patient experience the shakes, increased blood pressure 179/131 with pulse 111 pm, shortened breathing. We called 911, took her blood pressure, took her mask off to view face, offered water and ice pack before EMS arrived. Epinephrine not administered.
65 2021-03-10 palpitations Sore arm Headache Palpitations All lasted 24 hours and then completely resolved
65 2021-03-10 atrial fibrillation Suddenly went into afib, shortness of breath, throat was tight for a short time, body felt cold insi... Read more
Suddenly went into afib, shortness of breath, throat was tight for a short time, body felt cold inside, shaking inside
65 2021-03-11 chest discomfort, chest pain About 10 minutes after the shot I felt a warm sensation inside my arm running all the way down to my... Read more
About 10 minutes after the shot I felt a warm sensation inside my arm running all the way down to my arm and my hand went numb . I waited a few more minutes then I was released. Then 1/2 hour later my eyes were very sensitive to light I wore sunglasses. Then five hours after the shot I had chest discomfort on left side of my chest which felt like I was having a heart attack pain subsided then every 2 hours it came and went until the middle of the night. Then next day still having same chest pain. Then I had difficulty swallowing was choking so I called my doctor. I also had trouble breathing. Dr. Advised to go to ER if I needed to. I rested and rested and monitored myself. Blood pressure fluctuated somewhat. Still had chest pain and discomfort 24 hours after the vaccine. I had never had chest pain or discomfort before. It was quite alarming. Not being able to swallow was alarming also. Several years ago I had an allergic reaction to a cleaning problem some of the same symptoms it was very scary no heart or chest pain with that allergic reaction to a cleaning product that had bleach in the product.
65 2021-03-11 atrial fibrillation Adverse event: 36 hrs of Atrial Fibrillation. BP157/107 HR 158 Treatment: Rx blood thinner (Eliquis... Read more
Adverse event: 36 hrs of Atrial Fibrillation. BP157/107 HR 158 Treatment: Rx blood thinner (Eliquis) and beta blocker (Metoprolol) No further adverse event to second Pfizer Covid Vaccine dose Lot #EN6202 on 03/21/2021 while on prescribed treatment. Ok now while on meds until appointment with cardiologist in May 2021 (FYI-My sister also had similar adverse reaction to Moderna 1st dose)
65 2021-03-11 lightheadedness Patient experienced vasovagal response 10 minutes after dose given. Diaphoretic, vital signs remaine... Read more
Patient experienced vasovagal response 10 minutes after dose given. Diaphoretic, vital signs remained stable. Patient stated "feel like I could pass out". Observed for 30 minutes with full resolution of symptoms.
65 2021-03-13 palpitations, hypertension The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got naus... Read more
The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got nausea. Was sent to Urgent Care office where I got EKG, which showed no problems with my heart. Went home, weak. Woke at 2:00 am with night sweats. When I got up I noticed swelling on face, throat, hands & feet. Faint pink rash ran up both fore arms and I had welts rising on my wrists. Nurse line I called said to to to ER asap, Took me a few hours to find a ride, my throat was closing up more by that point. I could tell over a few hours that my throat was swelling up. Went to nearest ER where I was very mentally confused. They gave me a shot of steroids and Benedryl. Later that night I got chills and was VERY weak. Had night sweats again. After a few days of rest, am still weak.
65 2021-03-14 blood pressure increased Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to ... Read more
Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to Hospital. Was administered IV Benadryl and Prednisone. Slept for three hours. BP dropped to 165 and was released with Benadryl and Prednisone to take for the next four days. Next several days of nausea, diarrhea, fever, weakness, shakes. No energy. Not feeling well until March 14th.
65 2021-03-14 chest discomfort chest pressure, shortness of breath, ems evaluated, refusal to transport
65 2021-03-15 loss of consciousness Approx. 6 hours after first dose - she developed a funny feeling in her head. This feeling became pr... Read more
Approx. 6 hours after first dose - she developed a funny feeling in her head. This feeling became profuse sweating, stomach irritability, blacked out and fell to the ground. She had chills and ringing in her ears. symptoms resolved by next morning.
65 2021-03-15 loss of consciousness Patient felt like going to pass out and she did then, she was probably out less than in a minute; Se... Read more
Patient felt like going to pass out and she did then, she was probably out less than in a minute; Severe headache; Nauseous; Throwing up/Vomiting; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient (weight: 81.65 kg, height 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder form an unspecified date. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder. On 22Feb2021, the patient experienced sore arm. On 25Feb2021, the patient developed severe headache, nauseous, and vomiting (throwing up) and the patient felt like going to pass out and she did then, she was probably out less than in a minute. The patient described as following: so, on 25Feb2021, the headache increased throughout the day and her nauseousness continued throughout the day and in the afternoon with the pain of the headache she thought she passed out, she vomited that gave her little bit of relief but then she took "two (not clarified) Advil and went to bed". Clinical outcome of the adverse events was unknown at time of this report. Patient asked if should be expected the same kind of reaction when she got her second shot.
65 2021-03-15 chest discomfort Patient has a history of asthma and felt like her chest was tight and difficult to breathe. She used... Read more
Patient has a history of asthma and felt like her chest was tight and difficult to breathe. She used inhaler and nebulizer without relief.
65 2021-03-16 palpitations 1st day after-fatique/headache/weakness/chills 2nd day- better 3rd day- dizziness started late nigh... Read more
1st day after-fatique/headache/weakness/chills 2nd day- better 3rd day- dizziness started late night, subsided next morning. 4th day- same as 3rd 5th day- extreme dizziness at night, continued next day with sick feeling, stomach pain, leg weakness. Heart palpitations and racing(during night) Symptoms continued following 6th-10th days. Went to hospital emergency room 11th day due to doctor concerns of possible aFib. Admitted in Observation Unit overnight with IV fluids & heart monitor. Heart attack ruled out. Tachycardia event with follow up at cardiologist.
65 2021-03-16 chest pain, blood pressure increased, heart rate increased Lightheaded first. Arm soreness, Late evening tired, headache, chills, fever up to 100.6, slight bl... Read more
Lightheaded first. Arm soreness, Late evening tired, headache, chills, fever up to 100.6, slight blood pressure increase, pulse to 99 (normally 65), chest pain. Woke up 2/17 feeling better. Fever down to 98.8, pulse down to 74
65 2021-03-16 cardiac failure congestive, low blood oxigenation Patient was noted to have abrupt respiratory failure 2 days after taking the 1st dose. The patient w... Read more
Patient was noted to have abrupt respiratory failure 2 days after taking the 1st dose. The patient was admitted to the hospital for acute respiratory failure with hypoxemia secondary to acute CHF exacerbation. The patient had a transthoracic echocardiogram performed 2 weeks prior to hospitalization that was noted to show a left ventricular ejection fraction of 60-65%. At the hospitalization, her left ventricular ejection fraction was noted to decrease to 25-30%. Left heart catheterization was performed and showed no signs of ischemic heart disease (coronary artery disease). Patient was started on Entresto 24/26mg PO BID and Toprol XL 50mg PO daily and was diuresed with Bumex 1mg IV daily and was noted to have improvement in respiratory symptoms for which she was weaned off of BiPAP 15/5 with FiO2 of 50% down to room air. Patient had repeat transthoracic echocardiogram ordered prior to discharge and was noted to have an improvement in left ventricular ejection fraction to 48% prior to discharge. The only change was that the patient had the COVID-19 vaccination. Patient does not have any history of coronary artery disease or heart failure. Patient was worked up extensively for other etiologies of heart failure and none were found.
65 2021-03-16 palpitations Vaccine administered at 1145. At 1200 patient reported that her heart was racing, dizziness, lighthe... Read more
Vaccine administered at 1145. At 1200 patient reported that her heart was racing, dizziness, lightheadedness, and throat feeling "tight." BP 110/70. Symptoms progressed. 911 Called. EpiPen administered in L thigh at 1210. 1211 BP 112/60, still complaining of "throat swelling" and lightheadedness. EMS arrived at 1213 and transported patient by ambulance to Hospital emergency department at 1217.
65 2021-03-16 palpitations Vertigo, nausea, migraine headache, weakness, 4 days of hearing/feeling blood pressure/pounding in 1... Read more
Vertigo, nausea, migraine headache, weakness, 4 days of hearing/feeling blood pressure/pounding in 1 ear, but no fever or redness or pain in ears. No other infections or symptoms thereof. ER visit with blood and urine tests and an MRI revealed nothing definitive. Response to symptom-alleviating shots was less than desirable, hence the MRI. Sent home with anti-vertigo and anti-nausea prescriptions and referral to an ENT specialist (appt set for Mar 21). Patient unable to do anything but lie down. Efficacy of prescriptions is pending. Symptoms are projected to gradually subside and eventually disappear.
65 2021-03-17 blood glucose increased 30 mins post vaccination, client complained of new onset tickling in throat, voice hoarseness then c... Read more
30 mins post vaccination, client complained of new onset tickling in throat, voice hoarseness then cough. Client awake and alert. Vital signs stable, BP slightly elevated 164/71 @ 1226, O2 sats 98%. Blood glucose 154. Per staff protocol, Benadryl discussed but doctor declined to order administration. Daughter is driving her home.
65 2021-03-17 cerebrovascular accident Just 38.5 hours after receiving my 2nd dose of the Pfizer Covid-19 Vaccine I suffered a Cerebral Vas... Read more
Just 38.5 hours after receiving my 2nd dose of the Pfizer Covid-19 Vaccine I suffered a Cerebral Vascular Accident, a CVA, a Stroke @ 5:05a.m. in our home. My entire right side was paralyzed & unable to speak. My husband alerted #911 & fortunately @ the hosp. I received immediate life saving care. I had a C.T. Scan which revealed #2 blood clots in the left side of my brain. Intravenous T.P.A. was administered & then a thrombectomy was performed. Hospitalized approx. 5:45a.m on Sun., Feb. 28th, 2021 till my discharge on Wed., March 3rd, 2021@ 5:30pm.
65 2021-03-17 chest discomfort chest tightness, wheezing, sob, lightheaded. Evaluated by EMS-Refusal to transport.
65 2021-03-18 blood pressure increased Dizziness, nausea, blurred vision, elevated blood pressure, tightness in neck muscles
65 2021-03-18 loss of consciousness, lightheadedness Patient reports receiving the second dose of the vaccine on 3/17, feeling weak that night. on 3/18 ... Read more
Patient reports receiving the second dose of the vaccine on 3/17, feeling weak that night. on 3/18 she passed out x2 for several seconds each time. No postictal response. Patient was brought to the ER, diagnosed with vasovagal response Chest xray, EKG, labs normal
65 2021-03-18 palpitations Pt. states that she received the 1st pfizer covid vaccine to left arm at 0930 on 3/19/21. Pt. states... Read more
Pt. states that she received the 1st pfizer covid vaccine to left arm at 0930 on 3/19/21. Pt. states that she started to have heart palpitations around 15 minutes after receiving the covid vaccine. Patient noticed arm redness to bilateral arms. Pt. states that heart palpitations have resolved. Pt. denies shortness of breath, denies chest pain, denies difficulty breathing.
65 2021-03-18 troponin increased, heart attack Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing... Read more
Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing issues; Dry heaves; Mucus to come out; Nauseous; Dizzy; Headache; Ears became hypersensitive; Senses heightened; Throwed up; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Feb2021 (lot# EN6205), as 0.3 ml single, for COVID-19 immunisation. Medical history included seizure from 2017 (she hasn't had a seizure in 8 months), allergy (to a lot of things). Concomitant medications were not reported. The patient did not have other vaccinations in 4 weeks prior. Within 15 minutes from having the vaccination at the center the patient experienced the first seizure that lasted about an hour. The seizure was really bad, she had breathing issues, dry heaving like she was trying to throw up, mucus to come out. The paramedics checked her out, they stayed around until she came out of the seizure. The patient went home and then at 07:50 PM she started heavy shallow breathing, was nauseous, dizzy, had a headache, which also happened at the center. Ears became hypersensitive, it was so noisy like loud, but her husband and the paramedics said it wasn't loud but she could hear it, all of her senses were heightened. She had a second seizure and didn't known how long it lasted. Patient had another seizure at 08:25 PM, at 08:40 PM she had another one, at 09:00 PM patient was coming back around and had another seizure and her throat closed up and that's when she went to the hospital, when her throat started to close up. While the patient was in the emergency room (ER) she had another seizure, she had 6 total seizures, she has never had this many before so she knows it was an adverse event to this vaccination. The seizures also increased the patient's heart enzymes- troponin levels. The patient has an EEG, was given 4 baby chewable Aspirin, as she had a mild heart attack. She thought the seizure increased her troponin. The patient mentioned that during the first event at the center, she was so into the seizures, she remembers grabbing her left shoulder, her arm was hurting. She was so into the seizure and trying to throwing up that it didn't dawn on her. The hospital didn't tell her she had a mild heart attack, it just dawned on her because her troponin levels were up mildly and she thought the seizures were triggering something in her heart, not just her seizures. The patient got another headache and was dizzy and had shallowing breathing. Seizures recovered on 28Feb2021. The patient underwent lab tests and procedures which included chest x-ray: normal, it didn't show pneumonia or fluid on the lungs on 27Feb2021, electrocardiogram (EKG): normal on unspecified date, electroencephalogram (EEG): normal on 27Feb2021, troponin: increased on 27Feb2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
65 2021-03-20 blood pressure increased After Dose 1, that night, sore arm, pressure headache in top of head, fatigue. Everything improved w... Read more
After Dose 1, that night, sore arm, pressure headache in top of head, fatigue. Everything improved with exception of lingering headache for about 2 weeks. Evening after Dose 2, sore arm, worse headache, next day burning eyes, felt like flu. After 48 hours all improved but headache lingered in top of head pressure and nausea. On 3/3/21 8:15 am full blown sharp pain left side of head and then vise grip type headache like top of head was going to explode, severe shaking uncontrollable jerking, stuttering, worst headache ever, high BP over 200/170. Went to ER. CTA head wi 3D reconstruction, labs, etc. gave Toradol, Ativan Zofran Compazine and Fluids, Released after several hours, unspecified headache. Slept for 11 hours, next day severe brain fog and fatigue. On 3/6/21 awoke with same dull headache, but seemingly more jitteriness, by 10:40, another full blown extremely painful headache pins/needles from head to toe. Ambulance arrived BP 208/160ish. Transport to hospital. Ran many tests CT, etc. Gave Morphine, sent home after 5 hours. Saw Neurologist 3/17
65 2021-03-20 palpitations Dizziness, palpitations, racing heart. BP 145/82 (pulse 71), 100% O2 sat. Snack and oral fluids give... Read more
Dizziness, palpitations, racing heart. BP 145/82 (pulse 71), 100% O2 sat. Snack and oral fluids given. BP 123/59 (pulse 66), 100% O2 sat.
65 2021-03-21 deep vein blood clot 7 weeks after 2nd vaccine (given 01/16/2021) patient I developed a DVT in LLE. I have no underlying... Read more
7 weeks after 2nd vaccine (given 01/16/2021) patient I developed a DVT in LLE. I have no underlying health conditions, I have no risk factors and am in excellent health. Described as an "unprovoked DVT."
65 2021-03-21 chest pain Presented to ED on 3/14/21 with shortness of breath. She started feeling sick march 6th, with fatigu... Read more
Presented to ED on 3/14/21 with shortness of breath. She started feeling sick march 6th, with fatigue and no appetite. She developed a cough, loss of taste/smell, and then nausea/vomiting. She tested positive for Covid-19 on the 11th. She hasn't been able to hold down meds for the last week. She is having intermittent chest pains which she attributes to not being able to take her cardiac meds. Was started on supplemental oxygen and admitted to hospital. Is still admitted at time of writing.
65 2021-03-21 palpitations delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and nec... Read more
delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
65 2021-03-21 palpitations, blood pressure increased fever (spiking at 101.7), vomiting, body ache, heart racing and blood pressure raised
65 2021-03-22 hypertension Developed paresthesias, migraine headaches, and then was admitted on 3/20, three days after dose #2 ... Read more
Developed paresthesias, migraine headaches, and then was admitted on 3/20, three days after dose #2 with acute dysarthria thought to be due to complex migraine. MRI was negative for stroke. Additionally she had accelerated hypertension. She reports that migraines have not been a problem for 10 years prior. Hypertension has been an ongoing issue.
65 2021-03-22 blood glucose increased Pt notes that her BG levels started to rise about 5 days after the vaccination and remained elevated... Read more
Pt notes that her BG levels started to rise about 5 days after the vaccination and remained elevated for a little over a month later. Her BG readings have been improved since then. She also noted to worsening depression, fatigue, arthralgias associated beyond the initial period of the vaccination.
65 2021-03-22 chest pain, palpitations Started with severe headache, moved to base of skull and neck. Next day (Thurs. 3/18) extreme pain i... Read more
Started with severe headache, moved to base of skull and neck. Next day (Thurs. 3/18) extreme pain in neck, chest and shoulder area, headache, chills, fatigue, shortness of breath, heart palpitations, brain fog, malaise. I thought it would pass. Friday I felt no better - by evening I felt swelling in my neck and chest area. Noticeable swelling in clavicle area on both sides. Saturday & Sunday I rode it out until I could see my Dr. on Monday March 22. Dr. gave me a shot of steroids and a script for MethylPREDNISolone - 21 tablets. Today is Tuesday, March 23, 2021 and I feel much, much better. Dr. said to NOT get the 2nd shot and to report this reaction.
65 2021-03-22 chest pain shortness of breath chest pain
65 2021-03-23 chest discomfort Couldn't eat, very sore over whole body, needed to sleep most of days, very weak, nauseous, headache... Read more
Couldn't eat, very sore over whole body, needed to sleep most of days, very weak, nauseous, headaches, felt at times I might have been having a heart attack, very hard to breathe deep & felt like chest constricting. Lasted for a full 5 days.
65 2021-03-23 heart rate increased Her arm is sore and swollen; Her arm is sore and swollen; dizziness; rapid heart rate/she started ha... Read more
Her arm is sore and swollen; Her arm is sore and swollen; dizziness; rapid heart rate/she started having a bounding rapid heart beat; SOB/Shortness of breath; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199 and expiration date not provided), via an unspecified route of administration first dose on 07Mar2021 at single dose for Covid-19 immunization. The patient's medical history included allergy history to a of number of medication and things (I'm prone to allergies). The patient's concomitant medications were not reported. On 07Mar2021, the patient received the first dose and she went to sit in the observation area for 5 minutes. The patient was not anxious at all about getting it but she started having a rapid heart rate/ bounding rapid heart beat and SOB/shortness of breath that lasted about a minute. The EMT checked her out and asked her to stay longer and she did and after about 5 more minutes the same thing happened again. These episodes lasted about 1 minute and she had dizziness with it. Also she did not have any further episodes and she stayed a long time. Her concern was whether this was indicative of an allergic reaction and should she still get the second dose. The patient was asking for information about 2nd dose being given after 42 days. The patient stated that she has not had any more of those symptoms at all. The patient arm was sore and swollen that was all now. The events heart rate increased, dyspnea, pain in extremity, and peripheral swelling was assessed by the reporter as serious (medically significant). The outcome of the events heart rate increased, dyspnea, and dizziness was recovered and unknown for the remaining events. Information on Lot/Batch number was available. Additional information has been requested.
65 2021-03-23 fast heart rate, palpitations, heart rate increased Pt developed palpitations, tachycardia and lightheadedness appx. 10 minutes after injection. HR was ... Read more
Pt developed palpitations, tachycardia and lightheadedness appx. 10 minutes after injection. HR was noted to be elevated initially at appx. 120. Symptoms improved after several minutes. BP was noted to be158/94. HR improved to 70s. Pt noted a metallic taste in mouth as well. EMS services and hospital evaluation were offered but pt declined. She elected to go home and mentioned that she will call her doctor.
65 2021-03-23 blood pressure increased Tinnitus and rise in blood pressure
65 2021-03-24 blood pressure increased I tested positive for Covid in early December, 2020. 5 days after I received the vaccine, I woke up... Read more
I tested positive for Covid in early December, 2020. 5 days after I received the vaccine, I woke up to extreme dizziness with the room just spinning. My blood pressure increased to around 212/101 for much of the day. Normal is around 120/70. The dizziness finally subsided later in the day and the blood pressure went down to about 168/85 by evening. Then I minor developed a headache. I also developed sores in my mouth and on my tongue. I still have those today (the day after).
65 2021-03-24 chest discomfort, chest pain On-set on dizziness, severe pain and swelling in left arm. 6 hour later, severe pain shooting up my ... Read more
On-set on dizziness, severe pain and swelling in left arm. 6 hour later, severe pain shooting up my arm, radiating up my neck to my left ear. Severe pain on left side of chest, left breast and pain radiating over shoulder to back on left side. On scale of 1-10, the pain was a 9. Extreme heaviness on both sides of chest. I could breath but seemed difficult to take deep breaths. Took an extra dose of my blood pressure meds and it eased the pain to a 4-5 and I was finally able to sleep at 1:00 AM. Starting on March 8, 2021 I began having severe night sweats and continue to have them at present (March 25, 2021). Dr does not recommend that I take the second vaccination due to my reaction to the first one. He did recommend that I take the Johnson & Johnson but the health department is stating that I have to complete my vaccinations with the same on I started with. I will not have the second Pfizer.
65 2021-03-24 fainting Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: H... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hyperventilation-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Medium
65 2021-03-25 chest discomfort Pt complained of chest tightness few minutes after vaccine given with no shortness of breath or dizz... Read more
Pt complained of chest tightness few minutes after vaccine given with no shortness of breath or dizzines
65 2021-03-27 chest pain Chest pain, projectile vomiting, hives and swelling of the face, mouth and throat. Benedryl, steroid... Read more
Chest pain, projectile vomiting, hives and swelling of the face, mouth and throat. Benedryl, steroids, Nitroglycerin 3 times. I was not aware of any other test or results.
65 2021-03-28 fainting feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm fe... Read more
feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm felt mildly painful as injection went in; severe chills; fever; fatigue; restless sleep; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 65-years-old via an unspecified route of administration on 08Mar2021 08:15 (lot number: EN6203) as single dose for covid-19 immunisation. Medical history included covid-19 (covid prior vaccination: yes) from 10Jan2021 to an unknown date. There were no known allergies. Concomitant medication included acetaminophen taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 65-years-old, administered on the left arm on 15Feb2021 08:15 (lot number: EL9264) for covid-19 immunisation and experienced very painful injection site, chills, fever and fatigue. The patient reported that when she had her second vaccine on 08Mar2021, her arm felt mildly painful as injection went in, as though never healed from previous shot. This time, within 3 hours of vaccine, she began to feel fatigue, then began to experience chills and fever. She drank plenty of fluids, and took acetaminophen about 6 hrs after injection. In the evening her temp was up to 101.2 (her normal 97.2) and she took Acetaminophen at bedtime. Had very restless sleep, and at 5 AM on 09Mar2021, she got up feeling sick to her stomach ended up fainting onto bathroom floor. Luckily uninjured, and felt better upon "coming to". She was very fatigued rest of day, then normal next day. The patient underwent lab tests and procedures which included body temperature: 101.2 on 08Mar2021. No treatment was received for the events. The patient recovered from the events on an unspecified date.; Sender's Comments: Linked Report(s) : Same reporter,patient,product/ 2nd dose;US-PFIZER INC-2021269674 Same reporter,patient,product/ 2nd dose
65 2021-03-29 chest discomfort Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous repor... Read more
Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous report from a contactable 65-year-old female consumer reported for herself. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose (at the age of 65 years old) for covid-19 immunisation. Medical history included osteoarthritis due to car wrecks in younger years, migraine headaches, muscle spasms in back, covid-19 from Jul2020 to an unknown date (still on oxygen from being hospitalized in July with Covid and still get really tired, was home for a week and a half before being transported to hospital for 2 weeks, and received a plasma transfusion). The patient previously took codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, lisinopril and experienced drug hypersensitivity. On 21Feb2021 17:00, the patient experienced headache, tightness in chest, legs hurting from knees down, super tired (felt almost like he did when she had Covid infection and she was still on oxygen from being hospitalized in July with Covid). The outcome of the reported events was recovered. There was no treatment reported. Since the vaccination, the patient had not been tested for COVID-19.
65 2021-03-30 blood clot Blood clots; This is a spontaneous report from a contactable consumer (reported for herself). A 65-y... Read more
Blood clots; This is a spontaneous report from a contactable consumer (reported for herself). A 65-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6199, expiry date not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 10:45 at a single dose for covid-19 immunisation. Medical history included known allergies to sulpha. The patient had no Covid prior vaccination. Concomitant medications included atorvastatin (LIPITOR) and lisinopril, both taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had the vaccination on a public health clinic/veterans administration facility. On 12Mar2021, patient experienced blood clots that resulted in doctor other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was not tested for Covid post vaccination. Therapeutic measures were taken as result of the event which included that the patient was put on blood thinners. The event blood clots recovered with lasting effects.
65 2021-03-30 chest discomfort Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in ... Read more
Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in the throat; Headache; Dizzy; couldn't think clearly/her thinking wasn't clear; Confused; sensation in her chest; weak; fatigued; she had a full tongue which effecting her talking; tingling in her lips; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot Number: EN6198; Expiration Date: Jun2021), as single dose in left shoulder on 04Mar2021 at noon for COVID-19 immunisation. Medical history included Hashimoto's disease from May2012 and ongoing (autoimmune condition), ongoing undifferentiated connective tissue disease (UCTD) (autoimmune condition, unsure when diagnosed, started with polymyalgia rheumatica, then it went to rheumatoid arthritis (RA), then it went between Lupus and undifferentiated connective tissue disease), hospitalization: she had to go hospital twice in last 4 months, one was for Amlodipine which has polyethylene glycol and another time for Lisinopril as another blood pressure medication, she had 2 mild anaphylactic reactions in the last 4 months from amlodipine and Lisinopril, patient thought they all have PEG in the ingredients; underwent colonoscopy unknown results. There were no concomitant medications. On 04Mar2021 the patient experienced anaphylactic reaction, gasping for air, headache, dizzy, could not think clearly/her thinking was not clear, tongue swelling, swollen lips, throat closing/restriction in her throat, confused , sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips. Course of events was as follows: The patient drove two hours to get the vaccine. The patient was vaccinated on 04Mar2021 at noon. The reaction started immediately, the caller had a severe headache within seconds, a little bit of sensation in her chest. The patient's thoughts were getting mixed up, she was not thinking clearly. This was one of first things that happened. The patient stumbled a little bit and the nurses were there around her and said she better sit down now. Then the sensation in her throat was starting to feel like it was closing up, her lips were swollen; so she would say she was a little bit confused. The patient started getting dizzy and her thinking was not clear, her tongue swelled, she had a full tongue which effecting her talking, she was gasping for air, she needed a moment to regulate her breathing. In regards to swollen lips she added at first she had a tickle in the throat, tingling in her lips, restriction in her throat, then she started slurring her words before the ambulance got there. On site they responded and watched her because she did not know if the symptoms were going to get worse. The paramedics gave the caller oxygen and an IV, since she had a mild experience she wanted to see what she did not take any medications before taking the vaccine so she could see what it would do, she did not take an ibuprofen or Tylenol. Patient commented, she knew it was not recommended, but some people do it. The patient mentioned started speaking very badly and very fast, she started gulping for air, and was informed the histamines are hitting her. She felt like she was going to faint, she thought if she was able to count back from ten she was going to be knocked out. Once she counted back she started to feel better. Like she would not faint. She did not faint often. She mentioned counting backwards from ten when getting a colonoscopy or something like don't get passed five and then knocked out, so she knows the sensation that can occur. After 1.5 hours they decided to call the emergency number and that was when the ambulance came. The ambulance service was the one who did everything for the patient. Because the patient got in the ambulance, they required her to go to the hospital, she was in a bed in the hall, by the time her doctor had looked at her, her throat had opened up and was feeling reasonably well after an hour an half. Confirmed she was not admitted just in the Emergency Room. On 04Mar202 the patient was at the hospital and was gasping for breath. The patient was on an IV and they gave her 125 mg of Solu-Medrol, 50 mg of Benadryl, and 5 mg of nausea medicine, phedrol the caller thought it was called. They did a good job and that helped the patient down from the most severe symptoms and she wanted to report her symptoms. The patient has been looking around and she thought this reaction it was from the polyethylene glycol. She mentioned historically she had a minor reaction. She had to go hospital twice in last four months. One was for Amlodipine which has polyethylene glycol and another time for Lisinopril which is another blood pressure medication. She confirmed she visited the emergency room for all 3 of these cases. The patient was still very confused on 09Mar2021 and over the weekend, she had to rest, she was weak and fatigued. On 09Mar2021 it was first real day she went back to work. She worked and asked her brother to watch out for her. On 10Mar2021 she was starting to feel a little bit better as regarded anaphylactic reaction, she has recovered with residual effects from the anaphylactic reaction. Confusion was improved but stull a concern. The outcome of anaphylactic reaction was recovered with sequelae, of headache, swollen lips, confused was recovering, of gasping for air, dizzy, could not think clearly/her thinking was not clear, tongue swelling, throat closing/restriction in her throat, sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips was unknown. Patient asked if there was a conclusion about the PEG and her anaphylactic reaction. Her second dose was scheduled on 25Mar2021. Patient stated that her PCP and the CDC recommend to not get the second dose. Caller wanted to know if the anaphylaxis could be worse in the second dose. The patient wanted to know if she should she get the next dose. She was very concerned about COVID as well but did not know if it's worth her risking her life. Patient wanted to know if she can get the Johnson and Johnson vaccine after a certain amount of time after receiving the Pfizer COVID 19 vaccine, caller cannot get the second dose of the Pfizer COVID vaccine due to a reaction. As of 12Mar2021 patent stated she does not wish to be contacted any further. A Product Complaint was filed.
65 2021-03-30 blood glucose increased Seeing double; eye are puffy; high neutrophils; high sugar; Dizziness; Nausea; Dry heaves; The ER to... Read more
Seeing double; eye are puffy; high neutrophils; high sugar; Dizziness; Nausea; Dry heaves; The ER told them she had an allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband). This 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6206), via intramuscular in the right arm, on 09Mar2021 (at 14:00) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9266) administered in the left arm on 15Feb2021 (at 14:00) for COVID-19 immunisation. Relevant medical history included psoriatic arthritis, chronic obstructive pulmonary disease (COPD), emphysema, blood pressure abnormal, blood cholesterol abnormal, blood potassium abnormal, sleep apnea (she used C-Pap machine). Past drug history included allergy to penicillin. Relevant concomitant medications included hydroxychloroquine sulfate (PLAQUENIL SULFATE) for psoriatic arthropathy, ixekizumab (TALTZ) for psoriatic arthropathy, levothyroxine sodium (SYNTHROID), rosuvastatin for blood cholesterol abnormal, ranolazine (RANEXA), losartan for blood pressure abnormal, carvedilol (COREG), clopidogrel bisulfate (PLAVIX), potassium chloride (KLOR-CON) for blood potassium abnormal, escitalopram oxalate (LEXAPRO) for blood pressure abnormal, furosemide, tiotropium bromide (SPIRIVA) for COPD, fluticasone propionate, salmeterol xinafoate (ADVAIR) for COPD, acetylsalicylic acid (ASPIRIN (E.C.)), salbutamol (ALBUTEROL HFA) for emphysema and COPD and oxygen. On 11Mar2021, the patient became dizzy and nauseous and it just got worse and worse. She had also dry heaves. On 12Mar2021, she took meclozine hydrochloride (ANTIVERT, NDC 65162 0441 10) and ondansetron hydrochloride (ZOFRAN, NDC 65862 0187 30). Finally, on 13Mar2021 she had dry heaves and felt like she was going to pass out so they took her to the emergency room (ER). At ER, a computerized tomogram (CT) of head was done and resulted negative and blood work was normal except for high neutrophils and high sugar due to her drinking ginger ale for the nausea. The ER treated her with a shot of ANTIVERT and ZOFRAN and then lorazepam (ATIVAN). ATIVAN helped her so they sent her home with a prescription for ATIVAN. On 15Mar2021 (on Monday), she was no better. She was still dizzy and nauseous although the nausea was getting better as she could keep food down; she couldn't get off the couch without getting dizzy; under her eyes are so puffy and she was seeing double this morning when she woke up. The ER told them she had an allergic reaction. She was not sick at all when she got the shots; she was perfect. She used a C-Pap machine for sleep apnea and had oxygen that she used as needed. The patient had recovered from dry heaves on 14Mar2021, from seeing double on 15Mar2021; the patient had not recovered from dizziness and eye are puffy. The patient was recovering from nausea while the outcome of the remaining events was unknown.
65 2021-03-30 lightheadedness hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/n... Read more
hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/numbness in her feet up to her knees; little blue squares vibrating and pulsating on her wrists to her finger tips; Severe pain in her right hip; she was ready to pass out; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302) via an unspecified route of administration, administered into the left arm on 06Mar2021 09:45 as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. There were no concomitant medications. On 07Mar2021 at 17:30 patient's stomach had been getting harder all day long, she had severe diarrhea and when she was in the toilet she noticed numbness in her hand, numbness in her feet up to her knees, severe pain in her right hip. She also saw little blue squares vibrating and pulsating on her wrists to her finger tips, she was ready to pass out and thought that she might be having hallucination (AS REPORTED). She was trying to lift her hip off the toilet and just wanted to get to the floor to curl up in the fetal position. Then suddenly all these effects went away and she was fine the rest of the night and has been fine ever since. The patient was asking if these could be side effects of the vaccine or if it was just a part of her IBS. Outcome of events recovered on 07Mar2021.
65 2021-03-31 heart attack she is a heart attack survivor; This is a spontaneous report from a contactable consumer (patient). ... Read more
she is a heart attack survivor; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first vaccine ended up being a Pfizer vaccine. She received her Pfizer vaccine on 10Mar2021 and the next is scheduled 07Apr2021. She was wondering if she should schedule somewhere else to get another vaccine sooner. The patient was a heart attack survivor on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested.
65 2021-04-01 nosebleed 4/1/21: patient presented with chief compliant of left-sided epistaxis (nose bleeding). Patient sta... Read more
4/1/21: patient presented with chief compliant of left-sided epistaxis (nose bleeding). Patient states she has had epistaxis on and off for the past 5 days. Stated she feels nauseas from the blood in the back of her throat. Significant active heavy bleeding from the left nare was confirmed. Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine
65 2021-04-06 hypotension Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; Th... Read more
Nausea; fever; chills; headache; tired; diarrhea which led to loss of fluids; low blood pressure; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18Mar2021 09:30 am (Batch/Lot Number: En6204) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications within 2 weeks of vaccination were not unspecified. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received cefaclor (CECLOR) and experience allergies, and also received first dose of BNT162B2 (Lot number= En6200) on 25Feb2021 09:30 AM at single dose at left arm for COVID-19 immunization. The patient experienced nausea, fever, chills, headache, tired and diarrhea which led to loss of fluids and low blood pressure in Mar2021 08:00 PM with outcome of recovering. The adverse events resulted in hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage, emergency room/department or urgent care. Patient received treatments for the events included fluids, medicine, partial colon removal. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19: negative in Mar2021. Additional information has been requested.
65 2021-04-06 cardiac failure congestive Patient has COVID-19 + diagnosis 2/16, recovered, received first dose Pfizer on 3/5/21. Admitted to ... Read more
Patient has COVID-19 + diagnosis 2/16, recovered, received first dose Pfizer on 3/5/21. Admitted to outside hospital on 3/17 with acute on chronic respiratory failure due to HCAP and acute Congestive Heart Failure exacerbation. Discharged 3/22.
65 2021-04-08 deep vein blood clot, pulmonary embolism Saddle Pulmonary embolism and right lower extremity DVT
65 2021-04-12 cerebrovascular accident Stroke 13 days after 2nd injection
65 2021-04-14 chest pain Covid 19 Shortness of breath Chest pain
65 2021-04-15 heart rate decreased, very slow heart rate Lip numbness and tingling. Throat tightness. Weakness. Heart rate dropped to 42 bpm. Facial and ... Read more
Lip numbness and tingling. Throat tightness. Weakness. Heart rate dropped to 42 bpm. Facial and lip swelling. No SOB, no chest pain.
65 2021-04-15 pulmonary embolism Pulmonary embolism
65 2021-04-20 fast heart rate Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weaknes... Read more
Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weakness, & fatigue that had started 4/4/21 and diagnosed w/COVID-19 (4/10/21). She had just received 2nd vaccine (3/27/21), but had been exposed to COVID-19 the following day from a relative. She was discharged w/dexamethasone and pulse oximeter. Symptoms had continued to worsen and returned to ED where she was admitted for acute hypoxemic respiratory failure and tachycardia secondary to COVID pneumonia requiring steroids, remdesivir, oxygen, but unfortunately succumbed to her illness (4/18/21) given condition critical and prognosis poor.
65 2021-04-24 blood glucose increased blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; ... Read more
blood sugar was 140 this am; I don't feel right; don't feel right and I am breaking out in a sweat; clammy and lethargic; clammy and lethargic; respiratory rate was 8; This is a spontaneous report from a contactable nurse (husband). A 65-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EW0153), intramuscular, administered in Arm Right on 08Apr2021 12:30 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at Administration facility. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included diabetes, hypertension, depression, and known allergy to sulfa. The patient was not pregnant. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; and BP (blood pressure) meds, ECT therapy. The reporter stated that he and his wife came around at 12:30 (08Apr2021) and got her first dose of COVID vaccine. They waited in observation for 15 minutes. They went to go eat after the shot and he stopped to get gas and his wife stated "I don't feel right and I am breaking out in a sweat." So, he just came back over here to the vaccine site. When nurse approached the car, the patient in the passenger seat appeared diaphoretic, clammy and lethargic. She was responsive oriented to four spheres and denied pain. She said "I just don't feel right." Pulse rate was 63, respiratory rate was 8, BP was 120/60 O2 saturation 97%. The patient stated "I am a diabetic and blood sugar was 140 this am." She is on insulin and BP meds her spouse stated, Advanced EMT on site checking vitals. Epi 0.3 was given in right thigh per EMT and patient was transported to ER via ambulance. All adverse events started on 08Apr2021 01:15 PM. The adverse events resulted in Emergency room/department or urgent care. The patient received corrective treatment for the reported adverse events. Outcome of the events was recovering. The patient had no COVID prior to administration of bnt162b2 and was not tested for COVID post vaccination.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
65 2021-04-26 chest pain C/O Chest pain. Seen by paramedic and transferred to Hospital
65 2021-04-26 chest discomfort emphysema; wheeze from the pollen; allergies were not exacerbating but started the last few days; wh... Read more
emphysema; wheeze from the pollen; allergies were not exacerbating but started the last few days; wheezing cough; she had a sore throat; agitation; chills; anxiety; tight, shallow, and labored breathing/troubles breathing/Difficulty breathing/ has to yawn a lot to get the air in; tight, shallow, and labored breathing/troubles breathing/Difficulty breathing/ has to yawn a lot to get the air in; tightness in her chest; felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7534), via an unspecified route of administration, administered in Left Arm on 23Mar2021 19:00 as single dose for COVID-19 immunisation. Medical history included ongoing laryngopharyngeal reflux diagnosed about 5 years ago, ongoing anxiety, usually happens during stressful circumstances; diagnosed about 20 years ago and she had had the sensation of labored breathing, dry mouth, and accelerated heart rate then yes for work like with public speaking; sensitive: Sulfa drugs, aesthetic filler in her face and allergic reaction Hyaluronic acid filler collagen and she doesn't smoke and drink. Family history included daughter was diagnosed with psychotic episode and diagnosed with mental illness and it was stressful getting that under control and she was sensitive to medication and surgical procedures she doesn't tolerate narcotics. Concomitant medication included clonazepam (KLONOPIN). She reported that she was prescribed .125 of clonazepam and it was a dissolvable sublingual and she doesn't use it frequently as she has read about reliance and potentially addictive and she will take a walk or watch a boring video to try to get her mind off it. The patient previously took oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET) and she was sensitive to Percocet; and darvocet and experienced sensitive to Darvocet post surgery; and codeine, and vicodin and was sensitive to both drugs, advil and causes her stomach to be upset, shingles vaccine, HPV vaccine, chicken pox vaccine and got 1 pox from that about 15 years ago when it first came out. The only post-surgical medicine pain reliever she can take was Tramadol and more often than not she doesn't have to do anything beyond Tylenol extra strength. On 24Mar2021, 04:00, the patient experienced extreme chills, and anxiety accompanied with tight, shallow, and labored breathing. She had troubled breathing due to this. She mentioned that she went to the emergency room (ER) that morning. On 27Mar2021, the patient had emphysema and agitation. On 26Mar2021, early in the morning, she had the breathing issue that she mentioned first concurrent with agitation and anxiety like at same time with the extreme chills. The sensation of agitation was all combined together, it like hit out of the blue while she was getting ready to go to sleep. She stated that at 4am it hit her with a sudden bout of extreme chills and at the same time a sense of anxiety, it felt like she hit a wall and couldn't get a full breath. She stays up late but wasn't doing anything anxiety provoking, she thought she was reading recipes. She sat to calm herself as she was not sure if it was a reaction or anxiety at the initial reaction fueling it further so she tried to sort of lower everything in her system and was concerned it could accelerate and not subside. At the hospital, they took her in an exam room and did her vitals and she was there about 2-3 hours and it was early in the morning and at that point sometime they took a chest x-ray, EKG, and blood work and at that point prior to that while she was waiting she was feeling a little better, the worst had subsided and she suggested she go and they asked her to stay since she was already checked in and to be seen. The doctor looked at the results and read the film and questioned about emphysema and she felt that was unrealistic reading as she doesn't smoke, doesn't drink and it's not in her genetic make up. The doctor told her lungs were showing a lot of air and she said maybe it was because she was gasping and they told her to take a big gulp of a breath and hold it to get the X-ray. The doctor suggested she see a pulmonologist and she didn't feel that was warranted. She contacted her general practitioner and they recommended she get the 2nd shot and had her see an allergist who also suggested she get the 2nd shot. The patient stated that she was not really overweight and doesn't drink and doesn't smoke and the allergist didn't mention but she saw in the paperwork that a side effect could be difficulty breathing. She had no swelling, body rash, dizziness or weakness. Since that episode, she periodically throughout the day, and she can't tell if it's anxiety or allergies or something but she felt labored breathing and tightness in her chest and can't get a full intake of breath. She reported that when she sleeps on her back the sensation disappears completely and when she sleeps on her side it reappears a little; 1-2 nights after, it woke her from sleep and she doesn't think she was dreaming about anxiety. She stated that she has never had anaphylactic if this should escalate what to do and she decided to go to the ER and they had her wait an additional 2 hours for a follow-up reading that was all clear, all fine, except emphysema thing which was again, she was just researching and forgot the medical term, she this it was hype aeration, too much air sucked in. Her general practitioner recommended she see an allergist for a 2nd opinion and was surprised she was up on anything and didn't mention side effect and the handout said it could be a possible side effect. She has to yawn a lotto get the air in. She does have laryngopharyngeal reflux prior and she clears her throat which is probably annoying and controls that through diet instead of taking Pepcid AC. She has had to clear her throat a lot but never had labored breathing or shortness of breath, that to get a full breath sometimes she has to yawn to get past that tightness of shallow breathing or labored breathing. On certain days she doesn't feel it and thinks it was done and she will have a spate and it happens and she thought there was something stressing and does a reality check and again it's that time of year and when she was taking her walk and walked past a certain block she started to wheeze from the pollen on an unspecified date and she called her allergist to see about getting something. She had a mask and that helped a little. Her allergies were not exacerbating on 23Mar2021 or 26Mar2021 but started the last few days and she has a wheezing cough that had an extended sort of wheeze at the end of the cough. Before her cough for LPR it was annoying throat clearing. After the vaccine, she took that walk through that one specific spot on her route she got to coughing and thinking she needs to call and get something prescribed something if anything if she gets the second shot it will address any of the side issues if they were related to allergies so don't have to contend. It was every night where she sort of feels it and she sleeps through the night so if it was tension related it subsides and can't distinguish what is emotional and physical but she was sleeping through the night and it was an indication that it was improving. She reported that when she visited her son and after she returned he told her he was unaware he had strep and didn't know it, he was asymptomatic and she had a sore throat and went to urgent care and had an exam and didn't have strep and doesn't know what it was but she was feeling better by the weekend. She was supposed to go back and everything was shutting and she didn't go. Maybe she was exposed and just had a mild thing while she was there. She was tested for Covid on 26Mar2021 and her result was negative, but they did not do an antibody test. She wanted to know if difficulty breathing was a common reaction with the vaccine, and if the side effects would be lesser after the 2nd dose since she already had a severe reaction after the 1st dose and if she should still receive the 2nd dose of the vaccine. She was concerned the 2nd shot will be more pronounced than the 1st and she doesn't want to go through that and it be more severe. She has heard if you had that reaction you may have been exposed to Covid before and she may have been around people with Covid that had positives and she may have antibodies from an asymptomatic experience and it may do more harm than good and she should do the 2nd shot. She mentioned this to her allergist and was told if she has a similar symptoms to call and get a bronchodilator. She was onboard with that but wants to discuss it because she finds it hard to believe she was the only one that had difficulty breathing and was wondering what was the duration of this labored breathing. She was scheduled for the second dose 18Apr2021. Outcome of events sore throat was recovered on an unspecified date; and outcome of rest of events was unknown.
65 2021-04-27 blood clot April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vacci... Read more
April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vaccine experience with family member and relative. April 23 morning, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced death right after midnight at 12:04 April 25th. Reason of death given is "septic shock secondary to ischemic bowel & intra-abdominal sepsis". But it is the blood clots issue that is causing it. I was told that after my auntie got into hospital the very next day after Pfizer vaccine, hospital later found out that my auntie has blood blockage issue that is causing blood couldn't flow to her intestines. The acid in her blood was very high, 6+. After more than 6 hours without blood to her intestines, her intestines tissues start dying and turned black color. Doctor found out about this at the night of April 23, 2021 nighttime. April 22, 2021 morning is the day my auntie got her Pfizer covid vaccine. There is a very high chances of the Pfizer vaccine is causing the blood clots that lead to blood blockages.
65 2021-04-28 cerebrovascular accident stroke; face sunk in and changed/Bells Palsy; This is a spontaneous report from a Pfizer-sponsored p... Read more
stroke; face sunk in and changed/Bells Palsy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 16Mar2021 at 14:00 as a single dose for COVID-19 immunization. Medical history included a mild case of COVID-19, last year, on an unspecified date in 2020. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks of the COVID vaccine. On 21Mar2021, the patient's face sunk in and changed. The patient's symptoms were not improving. Her eye and right side of her face are affected. She cannot close her right eye. She worked on it and is now able to close right eye not like the left eye closes, but it doesn't blink as the left eye does. She has been using eye drops for this. She said it was Bells Palsy. The patient added that it is hard to look in the mirror. She will not get the second dose. She was not interested in taking the vaccine now. She wanted to wait and see. It being so new and see. Her sister took it and encouraged her, and said it is necessary because they like to travel. She got Prednisone when she was at the hospital, they gave her 60mg Prednisone. Her physician didn't want to keep her on it too long and said it may cause other complications. Her physician cut her off, she weaned her down 50mg, 40mg, 30mg, 20mg, then 10mg. When the patient noticed her face start to turn, she went to the ER. She thought she was having a stroke. The patient was not admitted to the hospital. The outcome of the event face sunk in and changed/bells palsy was not recovered while the outcome of the event stroke was unknown.
65 2021-04-30 coughing up blood coughing up blood; Coughing; Nausea; Headache; extreme fatigue; acute pain on the left side, she tho... Read more
coughing up blood; Coughing; Nausea; Headache; extreme fatigue; acute pain on the left side, she thought she cracked her rib/ rib pain; acute pain on the left side, she thought she cracked her rib/ rib pain; didn't sleep at all; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8757) at the age of 65-year-old, via an unspecified route of administration on left arm on 31Mar2021 at 13:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. There were no additional vaccines administered on the same date and no vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took aspirin and experienced allergy which was described as deadly. She never took medications since she found that out at 16-year-old. The patient received her first shot on 31Mar2021 at a pharmacy and mentioned that she was not sick at the time of vaccination, but she had a violent reaction to it. When she received it, she didn't feel anything. People said you will get a sore arm, but she got none of that. Then in the middle of the night on Friday (02Apr2021) probably around 3:00, she woke up with acute pain on the left side, it was rib pain, she thought she cracked her rib. On the same day, she also experienced difficulty breathing, and didn't sleep at all. On Saturday morning (03Apr2021), when she woke up, she had nausea, a headache, and extreme fatigue, but wondered if the extreme fatigue was because she did not sleep. The nausea and headache went away 8 hours later, on the same day. On Sunday (04Apr2021), she was coughing and coughed up blood. When she coughed, there was blood in the mucous. She mentioned that she still has acute pain, she could not get comfortable. Her sister passed away in January and she had a 5 pm train she was supposed to catch, she was responsible for the funeral. She was thinking that if she went to a hospital, they would keep her for 24 hours, she could maybe make it to the funeral but that was questionable. By Monday (05Apr2021), the acute pain was gone, she still had a cough, there was still blood in the mucous, she has occasionally blood in the mucous. The cough has not gone away but she was getting better every day. The difficulty breathing continued until about 08Apr2021 (as reported), but she still has some shortness of breath, but nowhere near as bad. She consulted her notes and said she was at 30% on 03Apr2021 and she felt today that she was at 80% and every day she was a little better and better. She has to sleep upright, she was afraid to sleep flat, she slept in her chair, last night for 2 nights she slept upright in her bed. She probably could lay down, but she was more comfortable upright. Because she was sleeping upright, she was not fatigued, she was not sleeping well but she didn't think that has anything to do with what was going on. The events did not result in emergency room or physician office visit. She is supposed to get her second dose on 21Apr2021but she did not want to get the second shot. She asked if she could wait and get the one shot from Johnson & Johnson. She didn't know where to go anymore. The outcome of the event "acute pain on the left side, she thought she cracked her rib/ rib pain" was recovered on 05Apr2021, recovered on 03Apr2021 for "nausea" and "headache", recovered on Apr2021 for "extreme fatigue", not recovered for "didn't sleep at all", and recovering for all other events.
65 2021-05-04 palpitations, heart flutter kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full... Read more
kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full tingling; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; mucoid eruption on her lower lip/ mucoid eruptions in her mouth, on her palate and down her throat; rash to her face, neck, chest, back, shoulders and thighs; has bright red palms and sole of her feet are bright red; it looked like Kawasaki disease; voice change; had joint pain in her left arm and could not use her left arm and her whole entire arm and hand; had left clavicle pain under the clavicle; spontaneous cough where her heart races; spontaneous cough where her heart races; felt she couldn't catch her breath; issues in her throat and neck area had something pressing around her throat; she was so tired; chest flutters; tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly; may be body inflammatory response to being vaccinated; This is a spontaneous report from a contactable Nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Mar2021 09:40 (Lot Number: EN6199) (at the age of 65 years old) as single dose (dose 1) for COVID-19 immunisation; and methylprednisolone (MEDROL), via an unspecified route of administration from an unspecified date to an unspecified date at short term increase of the Medrol dose (as reported), from unspecified date to an unspecified date at 2 mg (for four years, as reported), then from unspecified date to 10Mar2021 at 6 mg, then from 11Mar2021 to 13Mar2021 at 8 mg, then from 14Mar2021 to unspecified date at 6 mg, for Lupus. Medical history included diagnosed with asthma initially exercised induced and now it is seasonal and was diagnosed years ago (states she has not had to use her Albuterol inhaler that much now because it is seasonal but she is doing more outside and is allergic to outside things so she tends to use the inhaler more if needed), right leg paresthesia (she did have a right leg paresthesia and had that before the vaccine), autoimmune disorder, thyroid disorder and patient stated that she has lost height. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for asthma; levothyroxine sodium (SYNTHROID) taken for thyroid disorder; paracetamol (TYLENOL); and diphenhydramine hydrochloride (BENADRYL). The patient had a history of Lupus and is on maintenance Medrol 2mg for four years and before that she had a short-term increase of the Medrol dose with flares of her Lupus. She had the Pfizer COVID Vaccine 1st dose and then three days later on 10Mar2021 at 16:00, she thought what is going on and had her tongue tip so irritated and a strange feeling that it was a tiny bit edematous, her lower lip was full tingling. She had mucoid eruption on her lower lip and saw then that the next day thought it was swollen but it wasn't swollen. She had eruption on her tongue, had a rash to her face, neck, chest, back, shoulders and thighs. The rash was dispersed and there is a red raised rash with Lupus called Livedo reticularis and that is usually on the thighs but this rash on her was below her thighs and came up and dispersed between all the same rash elsewhere on her body. The healthcare professionals were closed so she took increased Medrol steroids and her Albuterol inhaler and Benadryl; the Benadryl was thrown out and discarded so she has no lot number to provide for it, stated that the Benadryl was the pediatric dye free bubblegum free. The Albuterol Sulfate HFA inhaler is 90mcg per puff and she does two puffs every 6 hours as needed; she had not taken the inhaler but she has trouble with asthma and took the Albuterol inhaler now as preventative and needs to use the inhaler as of yesterday (lot Y23B with expiry date Dec2021). Patient stated that she has the tools of her Albuterol inhaler, the steroid Medrol and the Benadryl and the knowledge so she prevented the symptoms she was reporting from being life threatening but stated the reported events were a little disabling and medically significant.She had joint pain in her left arm and could not use her left arm and her whole entire arm and hand. She had left clavicle pain under the clavicle and knows this did occur in the random trials but for her it went away after two days and is now back regarding the pain. She has bright red palms and sole of her feet are bright red. The next morning on 11Mar2021, her upper lip was tingling and she did go see her healthcare professional in town and sent photos to her Rheumatologist. As time went on she had tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly and her soles and palms were bright red; it looked like Kawasaki disease and she used to take care of children with Kawasaki disease. On Saturday which was the 3rd day she was on the Medrol 8mg and had the fight or flight cardiac symptom and she cut herself down on the Medrol on the next Sunday to 6mg which seemed to make her better. The redness was gone until she had the Pfizer COVID Vaccine 2nd dose yesterday and the healthcare professional initially said after her 1st dose of the vaccine to wait and see her rheumatologist do decided to do the increased Medrol dose of steroids and she stated she has got to get the 2nd dose of the Pfizer COVID Vaccine; the healthcare professional checked her lungs that were clear and her pulse ox was fine and she was not wheezing and she then went on increased steroids from Medrol 6mg to 8mg right away. She did have a right leg paresthesia and had that before the vaccine so she knows what it is like because she has issues with her spine but had not had the paresthesia in a long time. She increased to Medrol 8mg for the three days after the 1st dose of the Pfizer COVID Vaccine and got a flight or fight response. She had to increase the Medrol dose from 6mg and popped it up to 8mg and she had mucoid eruptions in her mouth, on her palate and down her throat and had a voice change. She has a laryngoscopy on Thursday (25Mar2021) with her ENT. She has pediatric doses of everything because she reacts to almost everything. The 2nd dose of the Pfizer COVID Vaccine was administered to her on 29Mar2021 09:45 with lot ER8732. Patient stated that anyone else would have gone to the emergency room but she took care of herself at home and knows the risk factors related to the vaccine. She absolutely felt the reported events were related to the Pfizer COVID Vaccine in terms of causality and she never had these issues before. The rheumatologist had experience with patients with autoimmune diseases and stated people with autoimmune disease have a heightened immune reaction to the vaccine no matter which vaccine they get and are overly active and then a vaccine is thrown in there and we are charting new territory. The next Thursday or Friday over a week now after the Pfizer COVID Vaccine she had a multisystem type of thing and on 18th and 19th of March she started having episodes and was not doing anything but quietly doing something and had chest flutters and spontaneous cough where her heart races and felt she couldn't catch her breath and is now on a 30 day event monitor. She was not sure this is due to the Medrol steroids or the Pfizer COVID Vaccine. She got her thyroid TSH level done because sometimes when the Synthroid dose needs to be lowered because it is too high for your body and you can have atrial flutter which she has had before in the past from her Synthroid dose being too high; states her Synthroid is 50mcg and takes it once per day by mouth and it is in a prescription bottle with no lot, expiry date or NDC. Patient saw her primary care physician again last Tuesday on 23Mar2021 and all the issues in her throat and neck area had something pressing around her throat and thought it was lymph nodes and woke up with a voice change and physician said he would take a look and he said it was not thrush and she would have to be scoped because he couldn't see in her throat. She had a referral for a CBC and Chemistry lab to be done on 25Mar2021 and TSH was in the usual range for her, the results from Thursday (25Mar2021) night had her BUN and creatinine and GSR (Glomerular filtration rate) abnormal. The rheumatologist called her that night and talked to the physician and said he considered this may be body inflammatory response to being vaccinated and could be that her kidneys were inflamed and she does not know as this is all new territory. For the kidney issues, the information was sent off to the rheumatologist who did orders and called the physician back the next day and she told him she thought she needed a nephrology consult and had urine chemistry, a urinalysis and looked for protein and did a blood draw for a chemistry screen with the following results on 25Mar2021: BUN 22.3, grade IIIa kidney failure, creatinine 1.28, eGSR-NAA 42ml/min, normal is over 60 and she usually runs 70 something. She went to the hospital over the years to have her chemistry lab done because she has Lupus and over the last two years she has never been below 60 for the eGSR-NAA. On 26Mar2021, she repeated the blood work and sent everything to her physician and the CMP had her BUN still elevated at 19.5, the creatinine was down to 0.97 and the eGSR-NAA was up to 58mL/min which is still abnormal; the urinalysis was all fine with no white cells and no leukocytes and no protein; the urine chemistry had the creatine of 8.5, the protein in the urine LVL was less than 0.4mg. Her CBC had her lymphs and monos down and she would expect having this response to the vaccine. Both physician called her on the weekend and they were concerned this came out of nowhere and now are monitoring her again in a month; her physician and rheumatologist both were entertaining this could be related to the Pfizer COVID Vaccine. She does not take vaccines because of what they do to the body and did take the flu vaccine in Oct2020. She was covid negative (unspecified date) and stated had to be screened on Friday 26Mar2021 before her laryngoscopy and did the PCR test and only does the PCR. States she was doing research and had conflicting information from her physician and rheumatologist who she first saw her physician, after her 1st dose of the vaccine and the rheumatologist talked about increasing her steroids and she told him she was so tired and how with increased steroids, do steroids impact the effectiveness of the covid vaccine being blunt immune suppressants. Physician said long term chronic steroids have no effect on the effectiveness of the vaccine. She has no had headaches, shaky chills like everybody else has because she is on immune suppressants and has an article that says some evidence for steroids diminishing efficacy in Pfizer COVID Vaccine. No prior vaccinations within 4 weeks. No additional Vaccines administered on same date of the Pfizer suspect. Events required a visit to physician office (No visit to the ER but did see her physician). The last action taken in response to the events for methylprednisolone was unknown. The outcome of the event had left clavicle pain under the clavicle was recovered on 12Mar2021; event has bright red palms and sole of her feet are bright red was recovered in Mar2021; outcome for the other events was unknown.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but possible contributory effects from patient's medical history and concomitant medications cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
65 2021-05-04 palpitations leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpita... Read more
leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpitation; light headed/dizzy; severe muscle pain; tenderness and soreness in her inner thigh of the left leg/throbbing pain; Chills; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208), via an unspecified route of administration in unspecified arm on 09Mar2021 (12:00) at single dose for Covid-19 immunization. The patient's medical history included ongoing hypothyroidism. Concomitant medication included levothyroxine been taking for 10-11 years for hypothyroidism. On 17Mar2021, Wednesday, the patient received the vaccine and had chills. On 18Mar2021, the patient had tenderness and soreness in her inner thigh of the left leg. On 19Mar2021, the patient had severe muscle pain on her calf of leg to inner thigh and it was throbbing so bad behind her knee on her left leg that she called her physician, and a sonogram was performed on 23Mar2021 which had found there was not a blood clot but there was severe inflammation along the major vein in her leg. On 20Mar2021, the patient had heart palpitation, her doctor told her to drink water and propel, she had heart spasms for 6 hours and felt lightheaded and dizzy. she thought she would go to the hospital, but she lives in a rural community and felt it did not make sense to go to the hospital. Palpitations and tenderness recovering. Her doctor and she was put on a heart monitor for her heart palpitations. She had heart palpitations with her hypothyroid but, this was totally different when she has had heart palpitations in the past. On an unknown date in Apr2021, the patient had diarrhea for 6 days. Patient had not been back to the doctor, but the nurse thought it was ok for her to take the second vaccine, but the patient was not comfortable with it. No prior vaccinations within the week. The patient never taken the flu shot. She had never received the flu vaccine or pneumonia nothing, so this was new for her getting the COVID vaccine. Caller clarified the chills started the week after she received the vaccine on Wednesday 17Mar2021. Severe muscle pain: Caller stated this happened on the 19, 20, 21, and 22 as well as the throbbing pain and then the next day on Monday 22Mar2021 she went to call her doctor and had a sonogram that next day on Tuesday (23Mar2021). Caller stated she still had the muscle pain in her left leg on the inner thigh but it was more so when she was active and once in a while she felt like her leg was bruised for a day or two but then it went away and she did not have a blood clot. Left leg throbbing: Caller stated this continually got worse and then on Sunday she felt so bad she laid in bed with her knee up and it throbbed like crazy. Caller stated this stopped about 2 days after she got the sonogram and it was not that severe it was just really tender and sore. Heart palpitation: Caller clarified that the heart murmurs she referred to earlier was actually heart palpitations. Caller stated this started at 8 in the morning and then at 10 in the morning she started getting light-headed and thought about going to the emergency room and figured no she will get through this. Caller stated she called her physician for the heart palpitations on Monday and she saw her doctor the following Tuesday and that is when her doctor had given her the heart monitor. Caller stated for 6 hours she felt horrible on Saturday since she knows the difference from her normal heart palpitations from her thyroid. Diarrhea: Caller stated this last for 6 days and was last week or so. Treatment: Caller stated no she is not a medicine taker she does not even take Tylenol or Advil unless it is a necessity. Outcome of the event chills recovered on 18Mar2021, tenderness and soreness in her inner thigh of the left leg/throbbing pain was resolving, severe muscle pain and inflammation along the major vein in her leg was not resolved, heart palpitation was resolving, light headed/dizzy was resolved on 20Mar2021, diarrhea was resolved on Apr2021, leg was bruised was resolved, heart spasms was unknown. No follow-up attempts are needed. No further information is expected. follow up(20Apr2021): New information was reported from a contactable consumer (patient) included: new events (coronary spasm, pain in extremity, phlebitis lower limb and bruising of leg) and event details. Case is upgraded to serious upon this follow up. No follow-up attempts are needed. No further information is expected.
65 2021-05-04 hypertension lower HTN (160/98); This is a spontaneous report from a contactable other healthcare professional. A... Read more
lower HTN (160/98); This is a spontaneous report from a contactable other healthcare professional. A contactable other healthcare professional reported in response to HCP Letter sent in cross-referenced case. A 65-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an intramuscular route of administration, in deltoid right on 28Jan2021 (at the age of 65-year-old) as single dose for COVID-19 immunization. The patient medical history included, first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, frequency (0.3cc) solution for injection, Batch/Lot Number: EH-9899), via an intramuscular route of administration in Lt Deltoid (Arm Left) on 23Dec2020; 15:48 as single dose for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination): None. Family Medical History Relevant to AE (s) includes, Father, HTN died ago 80 Lung cancer (Fire fighter), Sister: HTN. Concomitant medications included Losartan (MANUFACTURER UNKNOWN) taken for indication, suspected underlying HTN from 07Jan2021 and Continues. Most recent dose (daily dose and regimen including Formulation, Route, Frequency): 50mg PO (per oral) Daily; clonidine (MANUFACTURER UNKNOWN) taken for an unspecified indication from 28Jan2021 to an unspecified stop date. On 28Jan2021 at 12:48 (15 min after admin), patient had low HTN (160/98) resolved with Clonidine at site. Adverse event required visit to the physician office, visit to Emergency Room was not required. Relevant Tests were None. The outcome of event was recovered. Causal Relationship, a reasonable possibility that the event is related to suspect product/s was reported as Yes.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Hypertension cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
65 2021-05-04 platelet count decreased suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; suppress... Read more
suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; Very loose, sticky stool; Very loose, sticky stool; gaseous episodes; This is a spontaneous report from a contactable Other-HCP (patient). A 65-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248), second dose intramuscular, administered in Arm Left on 08Jan2021 08:00 (at 65 years old, not pregnant) single dose for covid-19 immunisation. The patient had no relevant medical history. The patient had her first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 1500 for covid-19 immunisation, intramuscular on left arm. Concomitant medication(s) included colecalciferol (VIT D3); magnesium; calcium; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN; monascus purpureus (RED YEAST RICE). On 16Jan2021, patient experienced very loose, sticky stool, gaseous episodes everyday since 2nd shot in Jan2021. Patient still do not have normal solid stool today. Patient went into the hospital 23Mar2021 with suppressed WBC and neutrophils and platelets. Tested for every virus, fungus and autoimmune disease and all came back negative and then had a bone marrow biopsy with negative results. Inflammation was seen in biopsy study. Given Neupogen to increase WBC/neutrophils only once which raised levels. Released 5 days later. Blood test 4/13 showed below normal WBC/neutrophils again but not as severe. Still trying to get healthy again. Adverse event resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Five days of hopitalisation. The outcome of the events was Recovering.Patient was given treatment Bone marrow biopsy, injection of Neupogen, IV antibiotics. No Covid prior vaccination. Patient got Covid tested post vaccination, nasal swab on 21Mar2021, 21Mar2021 and 23Mar2021, all negative. No Known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events diarrhea, flatulence, abnormal feces, platelet count decreased, neutrophil count decreased and WBC count decreased and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
65 2021-05-07 atrial fibrillation Atrial Fibrillation for 4 1/2 hours; 1st dose was 31Mar2021, 2nd dose on 04Apr2021; 1st dose was 31M... Read more
Atrial Fibrillation for 4 1/2 hours; 1st dose was 31Mar2021, 2nd dose on 04Apr2021; 1st dose was 31Mar2021, 2nd dose on 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 04Apr2021 13:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. The first dose was received on 31Mar2021 13:00 on the left arm. The patient medical history was not reported. Patient was not pregnant. Concomitant medications included flecainide, apixaban (ELIQUIS), atorvastatin and unspecified multivitamins. No other vaccines within four weeks. The patient experienced atrial fibrillation for 4 1/2 hours on 22Apr2021 07:30. Flecainide was given as treatment. Outcome of the event of atrial fibrillation was recovered on an unspecified date. Patient did not have covid prior to vaccination and had not been tested post-vaccination.
65 2021-05-09 blood clot, deep vein blood clot My left leg and ankle became very, very swollen and sore. I experienced severe pain in my left thigh... Read more
My left leg and ankle became very, very swollen and sore. I experienced severe pain in my left thigh, left knee and left calf whenever I sat, walked, went up and down stairs, while sleeping and I was limited in what activities I was able to do without pain. I went to the doctor on 3/29/2021 (9 days after my first shot) and the doctor sent me for an ultrasound of the left leg and an X-ray of the left ankle..
66 2021-01-04 hypotension 66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg ... Read more
66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg po, diphenhydramine 50mg PO at 1000. She also was administered NaCL 0.9% as a carrier for durvalumab as an infusion between 1000-1200. Pt was administered COVID19 vaccine at 1110. At 1120 patient called out stating "I just don't feel right". Pt was diaphoretic/weak/hypotensive. No swelling or respiratory distress noted during the episode. Attending physician and PharmD alerted and were at bedside. Per note, pt has needle phobia. Please refer to relevant history below for information regarding BP. Patient was monitored closely at the infusion clinic. She was able to receive her chemo agent as planned after she felt better from eating. Patient does not wish to get the second dose of covid vaccine.
66 2021-01-07 palpitations Pounding heart rate, it is faster than normal; can hear her heartbeat in her ears; Felt like she had... Read more
Pounding heart rate, it is faster than normal; can hear her heartbeat in her ears; Felt like she had fever and felt like kind of warmish; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0140), via an unspecified route of administration, on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included seasonal allergy, brain aneurysm, psoriasis, diabetic, blood pressure, immunosuppressant, cholesterol, and stent in brain. The patient's concomitant medications included metformin, semaglutide (RYBELSUS), valsartan for blood pressure, acetylsalicylic acid (ASPIRIN), ustekinumab (STELARA) as immunosuppressant for psoriasis, and an unspecified statin for cholesterol. The patient took the COVID vaccine yesterday morning (30Dec2020) at the hospital and she had like a pounding heart rate, it is faster than normal, but it is pounding. The patient can hear her heartbeat in her ears. The patient took her blood pressure and it is normal at 123/78 something like that. Heart rate is an over - little 72, 75, little bit fast but not tachycardia. The patient felt like she had fever and felt like kind of warmish, but her temperature is 98.2. As treatment, the patient took an over-the-counter medication, paracetamol (TYLENOL). The outcome of the events was unknown.
66 2021-01-10 body temperature decreased 1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 9... Read more
1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 99.3, muscle pain arms and legs worse Uncomfortable during the entire night (tossing and turning) 1/10/21- 07:30-General malaise(flu like symptoms)- muscle pain-feeling weak T-99 started feeling better during the late afternoon, still with muscle pain , T-98.7
66 2021-01-11 fainting "45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,... Read more
"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,muscle aches , pain some Syncope, nausea, sweating on and off, oral herpes outbreak just like I did when I had Covid -19 in April"
66 2021-01-11 chest discomfort onset of severe headache, chills, nausea, fever to 101.5 and chest tightness (pulse ox dropped to 92... Read more
onset of severe headache, chills, nausea, fever to 101.5 and chest tightness (pulse ox dropped to 92% requiring treatment with albuterol several times during the day. Inset of symptoms occurred approximately 16 hours after vaccination. Fever and other symptoms began subsiding approximately 24-28 hours after vaccination.
66 2021-01-12 cardiac arrest Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administ... Read more
Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association ("Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown
66 2021-01-13 chest discomfort Body Aches Back aches chest tightness
66 2021-01-13 heart rate decreased Dizziness Narrative: employee said her heart was low, so she laid on the floor C/o sweaty, diziness,... Read more
Dizziness Narrative: employee said her heart was low, so she laid on the floor C/o sweaty, diziness, lying on floor felt better. PMH of vascular response, taking beta blocker had juice felt better. Vss. 115/76 bp pulse 65. Recheck b/p 103/69 65 pulse, 101/68 pulse 69 oxygen sats room aire were 100. initial pulse was 43 b/p 115/76. Resolved after rest elevated legs, and fluids. Employee left about after and hour walking well, with no further c/o symptoms all seemed to resolved She was instructed to go the emergency room any further symptoms. She verbalized back the plan.
66 2021-01-13 loss of consciousness RESIDENT BEGAN VOMITING AND BECAME UNRESPONSIVE AT 12PM.
66 2021-01-14 fast heart rate Periods of tachycardia and diaphoresis started 7 hours after vaccine Had 3 "spells" of it ending am... Read more
Periods of tachycardia and diaphoresis started 7 hours after vaccine Had 3 "spells" of it ending am of 1/14/21
66 2021-01-14 blood pressure decreased Sore arm, loss of appetite, fatigue, extreme dizziness, drop in blood pressure
66 2021-01-17 chest pain 1345-pt called RN over and explained that she started having sharp chest pain under her right breast... Read more
1345-pt called RN over and explained that she started having sharp chest pain under her right breast after she leaned over in the chair to get her insurance card from her purse that was located on the floor. pt denies headache, dizziness, SOB, and nausea. After 5 minutes, pt states the pain has stopped. Upon review, pt states that the pain may have been caused by the underwire in her bra. Pt verbalized to RN that she has a follow up appointment with PCP for her hiatal hernia and she will mention her symptoms at that time. Pt states she felt fine and left vaccine clinic at 1356.
66 2021-01-19 palpitations Patient received first dose of COVID-19 vaccine and within 15 minutes felt tongue swelling and lip s... Read more
Patient received first dose of COVID-19 vaccine and within 15 minutes felt tongue swelling and lip swelling and felt heart was racing like she has been exercising. Feels lightheaded and dizzy. No trouble breathing. Patient was immediately assessed. Benadryl 50 mg given in clinic. Minimal improvement in lip and tongue swelling. Patient feeling more lightheaded. Vitals: BP 120/70, Pulse 69-72 O2 saturation 98-99%. PE: CV: normal rate: Respiratory: CTAB. HEENT: swollen upper and lower lip and tongue swelling (angioedema) Skin: mild redness in left hand, no hives noted Patient has had hx of anaphylaxis in the past to compazine and phenergan. Recommend ER Evaluation and monitoring.
66 2021-01-19 chest pain jaw pain x 3 min 5 minutes after vaccine administration, then had two episodes of chest pain after 1... Read more
jaw pain x 3 min 5 minutes after vaccine administration, then had two episodes of chest pain after 15 minutes measuring a 2/10 last 2-3 seconds each.
66 2021-01-22 hypotension Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm p... Read more
Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm pain, generalized muscle aches. 36 hours after developed chills, fever 102.5, headache, fatigue 48 hours fatigue, muscle aches present but less fatigue lasted 5 days
66 2021-01-24 atrial fibrillation, chest discomfort At 1132, Pfizer was administered. RRT called at 1138 in the post-vaccine Recovery area for a 66 y/o ... Read more
At 1132, Pfizer was administered. RRT called at 1138 in the post-vaccine Recovery area for a 66 y/o female that complains of upper chest tightness and temporal tightness, pain 3/10, non-radiating. 4 RNs responded to the scene. Head-to-toe assessment completed. She reports allergies to sulfa. She took multiple morning medications today, all regularly taken. Hx of stents, HTN, HLD, DM, WPW, irregular HR. Initial vitals: HR: 125, BP: 126/80, RR: 19, O2 98% on RA. Denies nausea and SOB. At 1148, she reported that her pain was subsiding. Given medical hx, RRT activated 911 response, called by Site Manager. At this point, client calm, AA0x4, skin WNL, resp WNL. 1201 EMS arrived and report was given to them. Client taken into ambulance for EKG. ALS response provided. Nitro and ASA given. EKG revealed A-fib, HR 120, O2 96%. Client to be taken to Hospital via ambulance, truck number 490. EMS assumed care at 1214. Husband that was with client was told of plan.
66 2021-01-25 palpitations, heart rate abnormal Patient approached Observation RN (3rd Floor stadium location) that her "heart was racing". Patient ... Read more
Patient approached Observation RN (3rd Floor stadium location) that her "heart was racing". Patient informed RN at 12:55pm, the injection was administered at 12:08pm in the left deltoid. Paramedic notified and vitals were taken: BP 117/75, HR 88, SpO2 98% on RA, RR 16. Patient denied lip or tongue swelling, difficulty swallowing, SOB, or chest pain. Patient stated she has history of anxiety, CAD, and LBB. Patient signed ambulance waiver declining transport to the emergency room. Patient left observation area at 13:18 on her own without the need for assistance.
66 2021-01-25 chest discomfort Patient with known allergies in observation area following injection noted flushed cheeks, chest tig... Read more
Patient with known allergies in observation area following injection noted flushed cheeks, chest tightness, and reported to clinical manager.(10:16) Given 25mg PO Benadryl and continued observation. AT 10:30, no resolution of symptoms-telehealth visit initiated. Vital signs stable, Oxygen sat at 97%, patient with c/o cough and scratchy throat. Order given and medication administered. Solumedrol 125mg IM. Additional 1 hour observation-symptoms resolved, and patient was discharged to home.
66 2021-01-25 cardio-respiratory arrest RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHI... Read more
RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHIBITED ANY SYMPTOMS. RESIDENT WAS OBSERVED TO BE UNRESPONSIVE WITH NO PRESENCE OF VITAL SIGNS ON 1/24/2021. RESIDENT WAS A FULL CODE, CPR INITIATED UNSUCESSFULLY. BASED ON REVIEW WITH PRIMARY CARE PHYSICIAN AND MEDICAL DIRECTOR, THE RESIDENT HAD NOT HAVE ANY OTHER EVENTS PRIOR TO RECEIVING THE COVID VACCINE 4 DAYS PRIOR TO EVENT.
66 2021-01-26 lightheadedness Pfizer-BioNTech COVID-19 Vaccine EUA Vagal Near-Syncope
66 2021-01-26 loss of consciousness Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A hea... Read more
Tiredness; A sore arm/Arm was a little sore; Dizziness; Passed out; Chills; Tremor in fingers; A headache; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EH9899, expiry date: unknown), via an unspecified route of administration on 06Jan2021 10:30 at single dose (Right upper arm) for COVID-19 immunization. Medical history included Blood pressure (takes blood pressure medication). The patient's concomitant medications included blood pressure medication. The patient experienced a sore arm, chills, tremor in fingers and a headache when she came home from being vaccinated. The morning after, she experienced dizziness, tiredness and passed out. She then checked her blood pressure and it was fine and then she went to bed and slept all day. She got up around 7 pm and was fine. It was further reports that the patient received first COVID Vaccine on 06Jan2021. She came home and was fine. Arm was a little sore. During night had chills and noticed fingers had tremors. Had a bad headache. Woke up in morning and went to do usual things. Was dizzy and passed out. Woke up on floor. Husband helped her back into bed and she slept the whole day. After that she was absolutely fine. They were curious, but a little bit concerned about taking the second dose. Advised patient to follow up with primary care physician. She went to primary care physician yesterday. Primary care physician advised her to take the second dose of COVID Vaccine stating he didn't see why she couldn't take it. HCP Details: Address and email address are unknown Received first dose of COVID Vaccine on 06Jan2021 around 10:30. Chills: began at 23:00 Fingers had tremors: began 23:00 Bad headache: did not provide time of onset Dizzy and passed out: 08:00 Woke up absolutely fine on 07Jan2021 around 19:00 Indication: 66 years old and it was available to her Causality: Yes, because she was fine before then History and Investigations: Takes blood pressure medication, but blood pressure has been normal. Product name not provided by caller. Vaccination facility type was at a skilled nursing facility. The outcome of the events was unknown. Chills, Tremor in fingers, headache, Dizziness, and Passed out were reported as Medically significant events. Reaction assessed for Chills, Fingers had tremors, Had a bad headache, Dizzy, and Passed out. Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including chills, tremor in fingers, headache, dizziness, and passed out, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
66 2021-01-26 cardio-respiratory arrest Unable to breath within 27 minutes, coded, rushed to emergency after crash cart medical trestment
66 2021-01-27 hypertension Elevated blood pressure. Pressure in ears muffled hearing. Loss of appetite.
66 2021-01-27 heart rate increased Joint pain for approx. 12 hours, chills for 12 hours - extreme chills for 4 hours, accelerated pulse... Read more
Joint pain for approx. 12 hours, chills for 12 hours - extreme chills for 4 hours, accelerated pulse for several hours - up to 118 bpm - normal is 60-70
66 2021-01-31 chest discomfort, blood pressure increased Schedulers notified RN pt complaint of difficulty breathing. She had been sitting in waiting room fo... Read more
Schedulers notified RN pt complaint of difficulty breathing. She had been sitting in waiting room for about 15 minutes post Pfizer COVID vaccine. Upon assessment, pt stated difficulty breathing and "heaviness in chest." She stated this "felt different" from anxiety. She was taken to an exam room for further monitoring. Pulse taken and WNL. Clinic Response Team was called. Pt was given water. She denied any other symptoms or worsening of current one. After about 10 minutes, pt stated feeling better. CRT arrival, EKG was performed and abnormal when compared to previous EKG from 5 years ago. Recommendation was given for patient to have further evaluation in ER.
66 2021-01-31 pulmonary embolism, chest discomfort, deep vein blood clot, fibrin d dimer increased Sunday: tightness in chest Monday : short of breath with walking Tuesday: extreme shortness of breat... Read more
Sunday: tightness in chest Monday : short of breath with walking Tuesday: extreme shortness of breath Wednesday: continued worsening SOB- sent for labs/ chest xray Thursday: D-dimer back -4.53- sent to hospital CAT scan showed multiple pulmonary embolisms without cor pulmonale / ultrasound- multiple DVTs, hospitalized 01-21 to 01-23/ heparin drip, transitioned to apixiban Discharged home
66 2021-01-31 chest discomfort Tingling in lips, heaviness in chest, scratchy tongue and throat.
66 2021-01-31 loss of consciousness Within 3 hours: Dizziness, severe diarrhea, vomiting, loss of consciousness, rapid shallow breathing... Read more
Within 3 hours: Dizziness, severe diarrhea, vomiting, loss of consciousness, rapid shallow breathing, BP 87/40, called 911, went to E.R.
66 2021-02-01 fainting Short fainting spell; This is a spontaneous report from a contactable consumer (patient). A 66-year-... Read more
Short fainting spell; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1686), intramuscularly on 14Jan2021 after 15:00 (her appointment was at 1510 but she had to wait past her appointment time before she received it) in upper right arm at single dose for Prevent Covid in hospital. No history of all previous immunization with bnt162b2 considered as suspect. No additional vaccines administered on same date of bnt162b2. Medical history included breast cancer from 9 years before 19Jan2021 (2012) and she has been Anastrozole since, she was only supposed to take Anastrozole for 5 years and when she was one month away from being done with it she had a Seizure and she was found to have a Tumor in her brain, she had had Srs surgery on her brain on 13Apr2016, she was prescribed Levetiracetam, a seizure medication, for two years and had not had any problem since. Concomitant medication included ongoing anastrozole taking for about 9 years for Post breast cancer. No prior vaccinations within 4 weeks. The patient previously took levetiracetam for seizure, she stopped taking Levetiracetam 750mg about 2 or 3 years before 19Jan2021, flu shot on 05Dec2020 for immunization at the age of 66-year-old. The patient reported that she had a short fainting spell around 8:30am on 19Jan2021 and she was not sure if it was related to the Covid vaccine. She described that she had been sitting for a while and when she got up she felt like this black curtain coming down which she has felt before in the past but she usually recovered and never lost control to where she fainted. Her husband was there to catch her. She clarified that she never passed out. She did not have any reactions in the past few days since she received the covid vaccine, she did not even have soreness at injection site. The event was not required a visit to Emergency Room nor Physician Office. Relevant Tests was none. The outcome of the event was unknown.
66 2021-02-01 blood pressure increased pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched ne... Read more
pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched nerve in my neck and blood pressure went up to 182/98; arm where she got the shot hurt like it was very tender; left breat hurt/then right breast hurt; having a little bit of trouble with asthma; congested and sneezing; congested and sneezing; bumpy rash on her chest and arms; puffiness/swelling in the neck; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration on 14Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing asthma and high blood pressure unknown if ongoing; both from unknown dates. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for asthma, unspecified vitamins and an inhaler for asthma. On 14Jan2021, the patient received the vaccination. She had a reaction to the vaccine almost immediately within 15 minutes of receiving vaccine. First, she had a pinched nerve in her neck and blood pressure went up to 182/98. Then about an hour later, the arm where she got the shot hurt like it was very tender. Then, her left breast hurt, followed by her right breast hurt. A few days later on 17Jan2021, she had breast pain and also pain under her arm. In Jan2021, she was also have some trouble with her asthma, was congested and sneezing. She had bumpy rash on her chest and arms. It was like tiny little bumps but it was not painful. She also had puffiness/swelling in the neck. The clinical outcomes of the pinched nerve in her neck, blood pressure went up to 182/98, arm where she got the shot was tender, breast pain, pain under arm, trouble with her asthma, congested and sneezing, bumpy rash, and puffiness/swelling in the neck were unknown.
66 2021-02-02 chest discomfort tightness in chest, numbness in legs and feet
66 2021-02-03 hypertension Immediate adverse reaction: Trouble breathing. Numbness L fingers, then jaw, then R fingers. Blood P... Read more
Immediate adverse reaction: Trouble breathing. Numbness L fingers, then jaw, then R fingers. Blood Pressure Emergency Room High. Fast heartbeat. Dizziness. Weakness. Trouble communicating-at a loss for words. Took Lisinopril-HCTZ20-12.5 while being monitored by RNs for BP and heart rate. 5 minutes thereafter, fuzzy cloud lifted from brain. Eventually felt OK to leave site.
66 2021-02-04 chest discomfort Pfizer-BioNTech COVID-19 Vaccine EUA Drive Thru Vaccination clinic - Within 10 mins of getting the ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Drive Thru Vaccination clinic - Within 10 mins of getting the vaccine, patient reports numbness to her central lips and tip of tongue. Diaphoresis and chest discomfort. Vitals were 157/78, 99, 16, 98% RA. Symptoms slowly started to resolve. 911 called and pt sent to ED. Pt takes Allegra (fexofenadine) daily. Symptoms resolved at 1:15pm. Troponins were normal - low concern for ACS. Diphenhydramine 25mg po on 1121 and prednisone 40mg at 1214. Discharge prescription for prednisone 40mg daily x 3 days.
66 2021-02-04 hypertension facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolv... Read more
facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolved), neck pain (ongoing, possible fibromyalgia flare); ocular irritation redness (ongoing, possibly unrelated)
66 2021-02-05 heart rate increased I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my hea... Read more
I was feeling pretty good until suddenly I felt lousy. My arm quickly started to get sore and my heart rate doubled. It took around an hour for my heart rate to slow down again. By bedtime all I had was a sore arm. That was gone within 24 hours.
66 2021-02-08 chest pain 15 min after vaccine had headache and chest pain requiring EC visit. Evaluated in EC without specifi... Read more
15 min after vaccine had headache and chest pain requiring EC visit. Evaluated in EC without specific intervention and discharge with follow-up precautions with PCP
66 2021-02-08 heart rate increased, fast heart rate, blood pressure increased I receive my second vaccination for Covid on January 4, 2021. Less than 36 hours later I experience... Read more
I receive my second vaccination for Covid on January 4, 2021. Less than 36 hours later I experience a rapid heart rate (110 - 128) and shortness of breath not related to activity. I had anticipated body aches, chills etc and did have those as well. Over the course of 4 - 5 days those resolved but my tachycardia and shortness of breath have not. I waited another week to see if it would improve and when that did not occur I made an appointment to see Cardiologist because quite frankly, I was fearful of my symptoms. My lungs remain clear, I have no difficulty taking a deep breath and my SAO2 is high 90's. I had my annual physical 1/18/2021 and my lab work was normal as was my EKG. I have never had shortness of breath and my heart rate was normally in the 70 - 80's range at rest. Doctor ordered testing and the results are in My Chart. I had a Echo/Stress/Echo which was normal. My EF was 60% and in spite of my extreme shortness of breath on the treadmill, there was no ischemia induced. Bp was elevated initially and during the test but returned to 130's/70's in recovery phase. SAO2 was 97% to 100%. I did a home sleep study on 1/31/2021 with results pending. Doctor stated there was nothing on my testing that would account for my symptoms. At my initial visit (1/26/2021)he started me on low dose Cardezem 120mg to address my heart rate. My heart rate has improved with Cardezem (increased to 240 mg 2/2/2021) but my shortness of breath with minimal exertion has not. I believe Doctor plans to order a PFT next. Because of the timeframe for new onset symptoms and my Covid 19 vaccination, I wanted to reach out to you for guidance. ? Second Covid Vaccination 1/4/2021 ? Shortness of breath and tachycardia 1/5/2021 ? Scheduled appointment with Cardiologist for 1/21/2021 and it was cancelled and rescheduled for 1/26/2021 ? Dr. appointment 1/26/2021, started on Cardezem 120 mg qd ? 1/31/2021 Sleep Study completed, results pending ? 2/2/2021 Echo/Stress/Echo completed, Cardezem increased to 240 mg qd ? PFT order pending ? Follow up with Doctor scheduled for 2/18/2021
66 2021-02-08 chest discomfort I started having itching on my lower back, almost like a rash. When I scratch it does come up. My he... Read more
I started having itching on my lower back, almost like a rash. When I scratch it does come up. My head and left ear and some spots on my hands, continue to itch. As soon as I start scratching little bumps come up. My scalp continues to become really itchy, I never had this before, the itch is constant. As soon as I scratch it starts to itch even more. I used some cream for my hands every once in a while. I started having pressure in my chest from my anxiety but felt a little more. She referred my to the Cardiologist to get a work up, but she believes it's due to my anxiety not the vaccine.
66 2021-02-08 chest discomfort Report discomfort to mid-chest with radiation to mid back. Treatment: Advil. Outcome: no improvement... Read more
Report discomfort to mid-chest with radiation to mid back. Treatment: Advil. Outcome: no improvement, continues to work, does not interfere with ADLS. Recommend to follow-up primary care doctor.
66 2021-02-09 blood pressure increased Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2... Read more
Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2nd dose pfizer vaccine given; after obtaining chart pt reports "feeling flushed, and then redness/rash on chest, and blood pressure go up". Pt given epi during rapid response; Pt reported a headache at this time. Pt denies dizziness, nausea, diarrhea, sob, no facial swelling, no lip swelling; no dysphagia; RR equal non-labored; Alert and orientated x4;
66 2021-02-09 palpitations headache; heart-pounding, racing heart beat,; dizziness; feelings of passing out; This is a spontane... Read more
headache; heart-pounding, racing heart beat,; dizziness; feelings of passing out; This is a spontaneous report from a contactable consumer. A 66-year-old non-pregnant female received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9262), via an unspecified route of administration in the left arm on 23Jan2021 10:00, at 0.3ml, single for covid-19 immunization.The patient medical history was not reported. Patient is an Rh Neg A blood type and did not have Covid, as she's been isolated for a year. Concomitant medication included gabapentin, paroxetine hydrochloride and atorvastatin. On 23Ja2021, after half an hour (10:30) of receiving 1st dose of the vaccine, patient experienced heart pounding, racing heart beat, dizziness, feelings of passing out. These symptoms lasted up to 3 hours. Patient sat her my car outside of the an emergency parking lot for 3 hours because she couldn't drive home during these symptoms. Patient was on the verge of going into emergency care. For the remainder of the day, patient's sitting heart beat was at 90. The next day, 24Jan201, she felt better but have on and off slight headache. She did not plan on taking the 2nd dose. The outcome of the events was recovering. The patient has not tested positive for Covid-19 post vaccination.
66 2021-02-10 chest discomfort Pt administered injection at 0749 and was sent to waiting area for 15 minutes post injection. Pt den... Read more
Pt administered injection at 0749 and was sent to waiting area for 15 minutes post injection. Pt denied chest pain, shortness of breath or adverse reactions prior to discharge to home. At 0830 patient contacted covid clinic phone line and advised she was experiencing chest tightness, and felt like her throat was swelling. Pt denied shortness of breath, was able to talk to complete sentences and was drinking water while on phone with covid clinic. Pt advised to proceed to Emergency room for further evaluation. Pt verbalized understanding of instructions.
66 2021-02-10 excessive bleeding Small rash on hind that itched for a couple of hours. Once it stopped itching the rash turned in to ... Read more
Small rash on hind that itched for a couple of hours. Once it stopped itching the rash turned in to what looked like a burn mark and the skin starting tearing and bleeding. I?ve been wearing a bandaid and I still have the mark today (1 week later), although it is slowly going away.
66 2021-02-10 fainting, hypertension Within 15-minutes of vaccination, the patient reported dizziness and feeling faint. EMS evaluated pa... Read more
Within 15-minutes of vaccination, the patient reported dizziness and feeling faint. EMS evaluated patient, no respiratory distress and no sign of increase work of breathing. Patient was hypertensive (158/78) with FSBG of 84. EMS transported the patient to the Medical Center emergency department. Patient was discharged from the ED with vasovagal syncope.
66 2021-02-10 hypertension Within 15-minutes of vaccination, the patient reported feeling lightheaded. Stated they had a histor... Read more
Within 15-minutes of vaccination, the patient reported feeling lightheaded. Stated they had a history of anxiety. EMS evaluated patient on-site. Patient was hypertensive (154/84). EMS monitored patient until normotensive, at which point, the patient refused transport to the hospital.
66 2021-02-10 hypertension Within fifteen-minutes of vaccination, the patient reported that her lips; tongue; and throat became... Read more
Within fifteen-minutes of vaccination, the patient reported that her lips; tongue; and throat became "tingly and itchy". She also reported feeling lightheaded. She denied difficulty breathing or pain. EMS assessed patient and found urticaria present on face. Lung sounds were clear with normal respirations. Patient was hypertensive (185/92). Patient remained hypertensive (177/96), but stated the tingling and itching sensations had subsided. They refused transportation to a hospital for evaluation.
66 2021-02-14 fainting, loss of consciousness I started with chills at 7 pm went to bed at 9pm at 3:30 I had to go to bathroom and almost fell off... Read more
I started with chills at 7 pm went to bed at 9pm at 3:30 I had to go to bathroom and almost fell off toilet. Caught myself but laid on floor and slept 30 min until I could get up and go back to bed. Chills were gone at this time. This morning at 10:30 I went to bathroom and blacked out. I was laying on floor but don?t remember what happened except I must have twisted my ankle and knee as they are very sore. I could not get up , no strength and hollered for Alexa to call my husband in the other part of the house. I rested in bed and finally came to couch and then around 3 ate a little but not hungry. I feel better, took a bath and resting but have a terrible headache.
66 2021-02-14 chest discomfort Swelling of throat and tightness of chest. Swelling of lips
66 2021-02-15 loss of consciousness patient received covid vaccine. screening questions answered. administered vaccine at 1321pm. pat... Read more
patient received covid vaccine. screening questions answered. administered vaccine at 1321pm. patient wheeled to vaccine waiting room. patient became lethargic and blacked out. patient not alert and awake for approximately 1 minute. patient came to, pulse 80, blood pressure 93/70, oxygen saturation 98%, husband at side, emergency cart and AED and oxygen brought to location of the patient. oxygen 2L nasal canula placed on patient. EMS called and Dr. came to site. assessment obtained with Dr. at site. patient awake, was able to speak full name but stated she was not aware of where she was. this reaction happened approximately 6 minutes post immunization. within approximately 3 minutes of episode where she states she felt she was going to "black out" she began to shake/ full body involvement. during this episode patient was following nurse commands. momements were rhythmic and lasted approximately 10 seconds then stopped. Patient brought back to exam room. at 138pm- temp 97.5, blood pressure 144/31, pulse 51, respiration 18. patient stated she felt warm and reports she felt she was going to black out. this episode lasted approximately 3 seconds and patient became alert at that time. vitals at 140 pm- blood pressure 124/60, pulse 75, respirations 16. vitals at 144pm- blood pressure 119/75, pulse 75, respirations 16. patient has dialysis 4 times a week for CKD stage 5. patient has lengthy medical history. patient reports her primary care doctor is Dr. who sees her frequently. patient reports she has an issue with internal bleeding with source unknown and at times has to have blood transfusions. no recent illnesses reported. patient states she ate breakfast around 10am today. patient states she has never had a vaccine reaction int he past or reaction to needles. EMS arrived on site approximately 1345. report given to EMS. patient alert with EMT. patient transferred from her personal wheelchair to EMS cot. patients husband left with patient to go to Medical Center. Patient tolerated vaccine well immediately after immunization. She reported no pain at injection site. Paper tape and 2x2 gauze placed at injection site due to allergy to tape. Allergy list was reviewed prior to administration of vaccine. Patient alert and oriented prior to vaccine to person place and time. Husband present in room. Verbal consent obtained by patient to receive covid vaccine today . Vaccine information handout and emergency use handout given to patient. Patient wheeled out of exam in wheelchair.
66 2021-02-16 cerebrovascular accident, hypertension Within 15-minutes, the patient reported a "pulsating sharp pain" behind their right eye. EMS evaluat... Read more
Within 15-minutes, the patient reported a "pulsating sharp pain" behind their right eye. EMS evaluated the patient on-site and they were found to be hypertensive (173/88). The patient proceeded to a emergency department. In the ED, the patient remained hypertensive with a mild generalized headache. They reported that their eye pain is constant but comes in waves of higher intensity. Differential diagnosis was possible stroke due to right-sided hemianopsia and right-sided ptosis. Patient was admitted and evaluated. Aspirin was administered and blood pressure was monitored prior to discharge.
66 2021-02-17 inflammation of the heart muscle Enlarged or inflamed heart, lungs full of fluid, myocarditis, vomiting, dehydration
66 2021-02-17 chest pain Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest... Read more
Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest pain; body ache; high fever; fatigue; profuse sweating; belabored breathing; hot; butterfly rash of face; This is a spontaneous report from a contactable physician (patient). A 66-year-old female (Not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 11Feb2021 14:30 at single dose for covid-19 immunization. Medical history included hypothyroidism, hypertension, hypercholesterolemia, breast cancer, osteoporosis, ligamentous RA, degenerative joint disease (DJD). The patient had known allergies to cilantro, cephalosporins, all morphine and morphine derivatives, Herceptin, astralogous mushrooms, gadolinium dye, fentanyl. The patient's concomitant medications reported as other medications in two weeks was yes.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, eye pain, earache on side of shot, itching both arms, severe jaw pain, severe chest pain, body ache and high fever &fatigue - profuse sweating, belabored breathing hot butterfly rash of face on 12Feb2021 at time of 06:00 AM. AEs resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient received Prednisone 80 mg and Benadryl 50 mg as treatment. Prior to vaccination, the patient was diagnosed with COVID-19. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab and PCR test: negative on 09Feb2021. The outcome of events was recovering. Information on Lot/Batch has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-02-18 hypertension, heart flutter Heart flutter, hypertension
66 2021-02-18 heart rate increased Pfizer, dizzyness, sore injection site, fast heart rate
66 2021-02-18 chest discomfort, fast heart rate Within 10 minutes of receiving vaccine, caregiver developed tachycardia, lightheadedness, chest tigh... Read more
Within 10 minutes of receiving vaccine, caregiver developed tachycardia, lightheadedness, chest tightness, and a headache, was taken to the ER and monitored and released.
66 2021-02-19 chest discomfort PATIENT RECEIVED VACCINATION. APPROXMATELY 10 MINS LATER THROAT FELT "STRANGE". BECAME HOT AND HAD M... Read more
PATIENT RECEIVED VACCINATION. APPROXMATELY 10 MINS LATER THROAT FELT "STRANGE". BECAME HOT AND HAD MINOR CHEST TIGHTNESS. VITAL SIGNS REMAINED STABLE. OBSERVED FOR ADDITIONAL 30 MINS. LEFT ON OWN ACCORD WITH RESOLVED SYMPTOMS.
66 2021-02-21 loss of consciousness Pt went to unconscious; reported SOB and then slowly went unresponsive. code blue called immediately... Read more
Pt went to unconscious; reported SOB and then slowly went unresponsive. code blue called immediately, patient still with BP WNL, oxygenating fine, had a pulse. gag reflex+ when oral airway placed. Taken to ED w/ team. Epi IM given, Ativan given, Benadryl given, glucose given. Pt became awake and alert, talking, observed at ED, then discharged to home at 1226
66 2021-02-21 cardio-respiratory arrest, pallor Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through th... Read more
Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through the pharmacy LTC partnership vaccination program. Resident had no adverse effects until around 8:00 pm she began complaining of body aches, and chills, Tylenol was given at this time. Around 9:30pm resident was sleeping in bed. Around 12:00 am the CNA called nurse into room to assess resident as the resident stated she did not feel good. Temperature at that time was 102.2, and vomiting. RN came to assess @ 1220 am She was noted to be vomiting, diaphoretic, pale and having trouble breathing. Temp was 97.3 after vomting, Pulse 53, Resp 20, o2 sats were 40-45%, unable to obtain Blood pressure, Applied 5 L of oxygen at this time and had LPN call 911 immediately. Resident was repsonsive and able to follow staff members instructions but was only answering yes or no simple questions at the time time of assessment. Paramedics arrived at 0040 and resident was sent to Hospital. @ 0130 ER nurse called to nursing facility to notify resident had coded in the ER and passed away @ 0110.
66 2021-02-22 blood clot 2 days after vaccination right thighs and right leg started to have pain similar to pain I got with ... Read more
2 days after vaccination right thighs and right leg started to have pain similar to pain I got with polymyalgia rheumatica that I have had in past and I though it was a flare up. A couple of days after that right leg started to swell and was warm. Went to ER on 1/29/2021 and had doppler which showed blood clots from groin area to below the knee. I was placed on Xarelto at that time. Got 2nd dose and about 24 hours latter back of thighs started to hurt again. Called doctor and applied heat and elevation and had no new swelling but I remain on Xeralto. Not sure if it was related but I have had no history of blood clots. 2 years previously broke my right patella and was with brace and no weight bearing for about 8 weeks and brace for 12 weeks without clot issues. Traveled by car a couple thousand miles last year and no issues.
66 2021-02-22 oxygen saturation decreased Dyspnea at 3different times within 24 hours
66 2021-02-22 ischemic chest pain, palpitations Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet... Read more
Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet, itchy rash all over torso, heart palpitations and pain.
66 2021-02-23 blood pressure increased Elevated blood pressure: 140/90
66 2021-02-24 blood pressure increased, heart rate increased, chest discomfort Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing.... Read more
Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing. These symptoms came in waves and is a normal reaction I get with medication I am sensitive to. However because I not having a normal reaction, I was told to go to an emergency room for a EKG. I knew this wasn?t a heart event, but a reaction to the vaccine. It is a normal reaction for me. I?ve dealt with it most of my life.
66 2021-02-25 heart rate increased Patient experienced increase heart rate with mild itching on right hand and right ear.
66 2021-02-26 loss of consciousness Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank... Read more
Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank about 20 oz of Crystal Light Peach Tea over night. Got up at 5am to get more to drink and find another place to rest. went into my kitchen to fill container and passed out. Woke a few seconds later. Left side of my forehead was bruised and swollen above left eye. Over the last 4 days both eyes an cheeks are bruised. All day felt like I had the flu without the fever. I did not go to the hospital.
66 2021-02-27 blood pressure increased Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and... Read more
Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and again the day after. Injection site became red and itchy within an hour of injection; redness has spread down the arm and continues to itch on day 3. This did not occur with first jab. Loss of appetite, fatigue, and brain fog, the day of and next day.
66 2021-02-28 chest pain Complaint of dizziness. Denies shortness of breath, chest pain, difficulty breathing and pain. No bl... Read more
Complaint of dizziness. Denies shortness of breath, chest pain, difficulty breathing and pain. No blurred vision. Patient did not eat or take prescribed medications prior to vaccination. Patient alert and oriented x3. Vitals: BP 120/78, T 97.9, P 89, R 18, O2 95%. Vitals prior to discharge BP 122/80, T 97.4, P 91, R 20, O2 95%. Patient discharged from clinic.
66 2021-02-28 blood pressure decreased Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room.... Read more
Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room. While she was sitting down patient started to complain of itchiness at injection site and felt like needed to scratch arm about 3 times, lasted only a minute. Started to feel lightheaded about 5 minutes after sitting down in waitng arae and notified observer. Felt weak and lighthed. Offered a wheelchair but refused and able to walk back to examination room. Taking Topamax this am for headaches, no other medications. Has COPD. Caring for adult daughter who is disabled and her husband left for a trip last Wednesday and back tonight. Patient often has interrupted sleep and up every couple hours with daughter. She has another daughter who will come and help at times but no one else around due to COVID concerns. Ate granola, blueberries, yogurt for breakfast this am Offered water in exam room, crackers and apple juice but patient refused. States has IBS and not want to eat other things In exam room feeling anxious, but the lightedness disappeared within 10 minutes. B/P decreased to 128/72. No nausea, abdominal pain, SOB. Denies any new illness. Has chronic cough with COPD Patient alert and oriented during entire visit and pleasant in conversation.
66 2021-02-28 chest discomfort Pt given Pfizer COVID-19 Vaccine (first dose) around 1100. Waited 30 minutes post-vaccination observ... Read more
Pt given Pfizer COVID-19 Vaccine (first dose) around 1100. Waited 30 minutes post-vaccination observation period and left vaccine clinic. Pt reports she noted SOB going up the stairs to leave the building. Reports she waited upstairs for a while and symptoms did not resolve.. Pt reported back to healthcare facility to report symptoms at 11:45. Brought to observation area, vital signs checked (125/76, HR 60, O2- 99%). Reports SOB/tightness in chest continues at rest- Emergency Response Team is called. 1152- develops thickness in throat and coughing that becomes progressively worsening. Emergency Response Team arrives, Provider advises Epi-Pen. Administered Epinephrine Auto-Injector at 1155. Pt is transported to ER by Emergency Response Team.
66 2021-03-01 hypotension Nausea, diarrhea, body aches, hypotension, headache
66 2021-03-01 blood glucose increased Patient received 2nd Covid 19 Pfizer vaccine shot on 22 February 2021. The patient had a past histo... Read more
Patient received 2nd Covid 19 Pfizer vaccine shot on 22 February 2021. The patient had a past history of having a reaction to the H1N1 vaccine. patient reports she did well with her first COVID vaccine-reports no issues. A few minutes after the vaccine was injected, it was reported from the nurse the patient was lethargic, sluggish, and the patient complained of arm weakness and lightheadedness. Fire department arrived to the scene first and vital signs were taken, all vitals were WNL. Patient's glucose was 119 on her continuous BG monitor. She reported she was feeling better, but still weak. Her vitals in the ED were BP 174/81 and HR of 53. The patient stated she felt better and decided she did not need treatment in the ED.
66 2021-03-02 heart rate increased 1020 am Complaint of dizziness, increased heart rate and anxiety with sweaty palms. Patient stated t... Read more
1020 am Complaint of dizziness, increased heart rate and anxiety with sweaty palms. Patient stated that she did not take blood pressure medication this morning. BP 165/100, T 97.7, P 113, O2 98%. 1050 am T 97.9, P 67, O2 96%, BP 160/90. Patient states symptoms have subsided. Patient educated on taking blood pressure medication as directed by primary provider. Patient discharged from clinic.
66 2021-03-02 chest discomfort About 3 minutes after COVID-19 Injection, patient started to have numbness in lips, tongue felt swol... Read more
About 3 minutes after COVID-19 Injection, patient started to have numbness in lips, tongue felt swollen, chest and abdomen tingling and tightness. Lasted about 5 minutes and then resolved.
66 2021-03-02 nosebleed, loss of consciousness I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous... Read more
I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EM9810) at her left arm, at 11:00AM 17Feb2021, for Covid-19 immunization. The patient received her first injection (Lot number EL9765) on 27Jan2021 10:15AM at her left arm. The patient's medical history was not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient was fine for 10 hours afterwards, went to bed, woke up disoriented weak and dizzy. She passed out going down stairs, came to on the floor at the bottom of the stairs, bloody nose, about an hour later passed out again in the kitchen and woke up on the floor. No warning either time, like light switch being turned off. The patient never had a reaction to anything before, never passed out before. She felt better at time of reporting. The adverse events happened at 07:00 AM 18Feb2021. The patient had not received any treatment for the events and not covered from the events. The patient had no Covid prior vaccination and Covid was not tested post vaccination.
66 2021-03-02 blood clot large knot right above the injection site/size of a half dollar/size of a silver dollar and where th... Read more
large knot right above the injection site/size of a half dollar/size of a silver dollar and where the needle went in was right at the base of that knot/like egg under the skin or clot; felt like she got a flu shot and could tell her arm was very sore; swelling started almost immediately after the shot/swelling was exactly underneath the injection site, just in the pronounced area/about 4 inches wide and about 2 inches high; thought maybe someone has hit a vein because it did bleed and ran down her arm; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EN6201, unknown expiration), via an unspecified route of administration on 18Feb2021 at 04:30 at a single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included tolterodine and adalimumab (HUMIRA). The patient reported that she received the COVID vaccine on 18Feb2021 at around 4:30. Firstly it was fine, she felt like she got a flu shot and could tell her arm was very sore. What concerned her was the swelling started almost immediately after the shot on 18Feb2021. She knew that was one of the symptoms. This morning and yesterday though (18Feb2021), she noticed some of the symptoms. She got a large knot that was right above the injection site. Yesterday, it was about the size of a half dollar, today it is about the size of a silver dollar and where the needle went in was right at the base of that knot. It feels like an egg under the skin or a clot. Like a knot (a hard spot underneath the skin). The patient was wondering if it was something she should be concerned about because the swelling was exactly underneath the injection site, just in the pronounced area. It was a rectangle and is about 4 inches wide and about 2 inches high and then right above that was where the needle went in. The large circle or knot was right above that and she was thinking possibly when she was given the injection she has never really bleed before. So, she thought maybe someone has hit a vein because it did bleed and ran down her arm. She got no problem. That happens at times, but she started thinking if this was a clot or it was something that is right above there because it is so pronounced, and it really hurts. The patient stated that she took some Aspirin last night and is going to take an ibuprofen in a little while. She mentioned that she takes this one pill and it has nothing to do with anything. The patient had lab work done (unknown results) that was about 3 weeks ago (2021). She also stated that she also take Humira which is a shot every 2 weeks and it said in the fact sheet that she should be concerned or be sure that she did not take any medicine that affects the immune system and Humira does weaken the immune system but she was not ask that prior to. The patient wanted to know if is that something she should be concerned about. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
66 2021-03-02 heart rate increased terrible gas and bloating - starting 12 hours after injection and lasting 1 day, rapid and irregula... Read more
terrible gas and bloating - starting 12 hours after injection and lasting 1 day, rapid and irregular heart rhythm - beginning 40 hours after injection - lasting 6 hours, extreme tiredness - day 7 & 8, lower back and hip pain - day 7 and currently day 10, general feeling unwell - most days
66 2021-03-03 ischaemic stroke, hypertension Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a ... Read more
Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9810, expiry: unknown), via an unspecified route of administration in the left deltoid on 01Feb2021 14:15 at a single dose for covid-19 immunization at a Physician office. Medical history included asthma, irritable bowel syndrome, pneumonia and borderline high cholesterol. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had her first COVID-19 vaccine on 01Feb2021 and second one is due on 22Feb2021. On 03Feb2021, the patient had a headache, but didn't think too much because it is a side effect. The headache lasted all through the weekend. Visual disturbances began 04Feb2021. She called her doctor on Monday and was seen by her doctor on Tuesday, 09Feb2021. The patient was referred to the eye center. Her headache was getting a little better. On 10Feb2021, the patient was seen at an institution, her retina and macula looked good, so she was referred to the ED. The patient was told she probably had a stroke. The patient was admitted to the hospital for an ischemic stroke. By looking at the MRI, the onset of the ischemic stroke would have been five to seven days prior, placing the onset on Wednesday, 03Feb2021, which was also the onset of her headache. There is no definitive cause of her ischemic stroke. The patient currently has an arrhythmia monitor on. MRI/MRA showed her vessels looked good. MRI showed evidence of the ischemic stroke. The patient has neurologists since being admitted to the hospital. It was thought that the headache was just because of the COVID-19 Vaccine. Causality was unknown, it was stated that they haven't found anything else as a cause. The patient's doctor stated she was borderline for high cholesterol. She was not hypertensive, but supposedly is now. The patient also had echocardiogram, EKG, manual neuro checks, and blood work but does not have the results. The outcome of the events was unknown. The has trouble reading now since the stroke.; Sender's Comments: Based on available information, the reported events are assessed as unrelated to the vaccine BNT162B2 and can be explained as intercurrent or underlying medical conditions in this elderly patient with excessive weight (BMI=29) and underlying elevated cholesterol. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-03-03 arrhythmia SOB, heart arrhythmia, slight nausea. Seen by EMT on site. BP 180/90, Afib on EKG, (None seen on 1... Read more
SOB, heart arrhythmia, slight nausea. Seen by EMT on site. BP 180/90, Afib on EKG, (None seen on 12 lead), lungs clear, O2 sat taken (no comment from EMT), Glucose checked, lungs clear.
66 2021-03-03 fainting She had syncope, nausea, vomiting on 2/10/21, 4 days after vaccine. She went to ED that day. She saw... Read more
She had syncope, nausea, vomiting on 2/10/21, 4 days after vaccine. She went to ED that day. She saw me today (3/4/21) and has had recurrent nausea, vomiting and dizziness but no further syncope.
66 2021-03-03 palpitations, hypertension Within 15-minutes of vaccination, the patient reported palpitations and feeling lightheaded. EMS ev... Read more
Within 15-minutes of vaccination, the patient reported palpitations and feeling lightheaded. EMS evaluated the patient on-site. The patient was hypertensive and transported to Emergency Department. In the ED, the patient remained hypertensive (199/95). Patient was administered clonidine and reported feeling improved. They were discharged with palpitations and hypertensive urgency.
66 2021-03-04 fast heart rate Systemic: felt like she was going to pass out, short term memory loss-Severe, Systemic: Shakiness-Me... Read more
Systemic: felt like she was going to pass out, short term memory loss-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
66 2021-03-05 fainting Pt experienced anxiety immediately following the vaccine shot and fainted
66 2021-03-06 lightheadedness Tingling, lightheaded, presyncope. BP readings: 97/62 (pulse 46), 98/60 (pulse 59). Given juice and ... Read more
Tingling, lightheaded, presyncope. BP readings: 97/62 (pulse 46), 98/60 (pulse 59). Given juice and water.
66 2021-03-07 palpitations, chest pain Nausea immediately with injection, injection site pain, tiredness, headache, body aches, dizziness, ... Read more
Nausea immediately with injection, injection site pain, tiredness, headache, body aches, dizziness, blurred vision, poor appetite, unable to taste food, feeling unwell. day later rash on chest, next day heart racing, breathing shallow and fast, chest hurting. roads were iced over, to unsafe to drive.
66 2021-03-07 cerebrovascular accident Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain w... Read more
Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain why she didn't feel well. She woke up feeling well and then quickly became disoriented and vomited. She was then unable to walk or communicate appropriately. Emergency services was called and she was transported to Emergency room. She was diagnosed with a posterior brain CVA and was treated with tpa and now remains hospitalized in the ICU with expressive aphasia and vision loss.
66 2021-03-08 hypertension Within 15-minutes of vaccination, the patient reported feeling lightheaded. EMS evaluated the patien... Read more
Within 15-minutes of vaccination, the patient reported feeling lightheaded. EMS evaluated the patient on-site. Patient was noted to be hypertensive (209/120) with an EKG showing NSR, rate 80 bpm, no ST elevation. EMS administered 3mL saline IV. EMS transported the patient to Medical Center Emergency Department. In the ED, the patient remained hypertensive (191/106). Repeat EKG indicated NSR, rate 70bpm, low voltage QRS, cannot rule out Anterior infarct. The ED physician administered 10mg Nifedipine and patient had improvement in blood pressure.
66 2021-03-09 skin turning blue I had breast cancer in 2003 and had to have a left breast removed and half of the lymph nodes were r... Read more
I had breast cancer in 2003 and had to have a left breast removed and half of the lymph nodes were removed. Due to the surgery I developed lymphedema and i have to wear a compression sleeve and glove seven days a week. A few minutes after the injection i was reading the reaction list and caught that it might cause lymph nodes to swell and about the time i was reading it i felt pressure in left arm i looked at it my arm and hand swelled to the point my hand and fingers turned blue i started to massage my arm and called the nurse she told to keep massaging after 30 minutes sitting there the arm was still swelled the nurse released me and told me if it got worse go to the emergency room. I came home kept massaging and elevated my arm about the time i went to bed around 9:00pm the swelling came down. The arm was normal when i woke up
66 2021-03-09 blood pressure decreased, pallor Progress Notes COVID VACCINE CLINIC 3/3/2021 Patient is a 66 y.o. female who was seen at Vaccine... Read more
Progress Notes COVID VACCINE CLINIC 3/3/2021 Patient is a 66 y.o. female who was seen at Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience feeling flushed/nausea. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress and vomiting. She reports she took her coreg 25 mg dose torsemide 20 mg doses this am. She did eat toast and yogurt around 7 this am. Past Medical History: Diagnosis Date ? Biventricular ICD (Medtronic) implanted on 8/19/14 8/20/2014 ? Depression ? Depressive disorder, not elsewhere classified ? GERD (gastroesophageal reflux disease) ? Heart failure (HCC) LVEF 40-45% by ECHO 1/2012. ECHO 11/13 LVEF 50-55%. LVEF 37% by nuclear stress test 2/20.14. ECHO 4/2014 LVEF 30-35%. LVEF by echo from 3/2017 LVEF 50-55%. ? hospitalization Admit on: 20111020; Diagnosis: Acute respiratory failure, acute on chronic systolic and diastolic heart failure; at: Stormont-Vail HealthCare; ? Hypertension ? LBBB (left bundle branch block) ? Mitral regurgitation Moderate secondary to annular dilation ? NICM (nonischemic cardiomyopathy) (HCC) Cardiac cath from 10/2011 normal coronary arteries. Nuclear stress test 2/2014 no ischemia. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, ear pain, sore throat, eyes watering, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, blood in stool, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/03/21 0920 03/03/21 0928 03/03/21 0937 03/03/21 1000 BP: 97/50 97/57 112/60 104/58 Pulse: 96 86 68 Resp: 18 16 14 Temp: 98.4 °F (36.9 °C) SpO2: 100% 100% 100% Blood Sugar 71 collected at 0922 Blood sugar 103 collected at 0945 Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: She is not diaphoretic. Comments: Flushed. Negative for diaphoresis Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Coloration: Skin is pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water, snacks and reclined Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Greatly improved after water/snack/reclining. Pt observed for 45 minutes in the bay. She feels comfortable going home. Her blood pressure drop may be related to her taking two medications that affect her bp as mentioned above. She's improved with hydration and snack. Recommended that she rest, monitor her bp at home. If symptoms worsen or returns, recommend evaluation in ED. Otherwise follow up with pcp office. Pt wheeled out with RN and husband. Pt voices appreciation of her care today.
66 2021-03-10 hypotension Progress Notes Family Medicine COVID VACCINE CLINIC, 3/3/2021 Patient: Patient a 66 y.o... Read more
Progress Notes Family Medicine COVID VACCINE CLINIC, 3/3/2021 Patient: Patient a 66 y.o. female who was seen at a COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. Past Medical History: Diagnosis Date ? Depression ? GERD (gastroesophageal reflux disease) ? Hyperlipidemia ? Hypertension ? Obstructive sleep apnea (adult) (pediatric) ? Osteoarthritis She does have a way to monitor her blood pressure. She last ate around 9:30 am ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/03/21 1315 03/03/21 1326 03/03/21 1340 BP: (!) 167/81 (!) 167/81 (!) 163/63 Pulse: (!) 103 (!) 103 80 Resp: 18 18 16 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait abnormal (has her own wheelchair that she uses for long distances. ). Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) HTN Overall well appearing, not in distress. Pt observed in the bay for approx 25 minutes. Bp slowly improving. She is here with husband who will take her home. She feels better after water and snacks. Pt encouraged to monitor her bp at home. Follow up with pcp if continues to be elevated. Pt and husband voices understanding and denies any other questions or concerns. Electronically Signed 3/3/2021 1:27 PM
66 2021-03-10 palpitations Racing heart, headache with sudden onset
66 2021-03-10 vaginal haemorrhage Vaginal bleeding at 3:30 am, bloodied underwear and sheets. Gynecologist gave me an internal ultras... Read more
Vaginal bleeding at 3:30 am, bloodied underwear and sheets. Gynecologist gave me an internal ultrasound of uterus, ovaries etc. were perfect. Had fatigue and aches for 24 hr. after vaccine. Also had a very bright pink, red rash covering the underside of my right arm and right chest, hot to the touch, some swelling, primary Doctor put me on antihistamines and antibiotics. Bleeding stopped. Rash and swelling is improving, still slight swelling on the underside of right arm 8 days later.
66 2021-03-10 nosebleed developed a nosebleed, I am treating by lying down
66 2021-03-11 loss of consciousness After 1 hour of light housework she walked approximately 200 yards to her daughter?s house to retrie... Read more
After 1 hour of light housework she walked approximately 200 yards to her daughter?s house to retrieve her dog. She bent over a couple times to pick up the dog then she became dizzy and passed out and fell to the ground. This has never happened before taking this shot.
66 2021-03-11 loss of consciousness, cardiac arrest Patient was vaccinated with her second dose on Wednesday, February 24th. A family member contacted u... Read more
Patient was vaccinated with her second dose on Wednesday, February 24th. A family member contacted us to let us know she was sitting in a casino exactly one week later and passed out, going into cardiac arrest. The patient did pass away.
66 2021-03-11 cardiac arrest Received shot 02/04/2021, sudden Cardiac Arrest 2/8/2021, found 2/10/2021
66 2021-03-11 hypertension c/o facial and tongue swelling, tongue tingling, flushed cheeks, Hypertensive at 207/93, HR 50s, O2s... Read more
c/o facial and tongue swelling, tongue tingling, flushed cheeks, Hypertensive at 207/93, HR 50s, O2sat 98. Recommended EMS transport, patient/SO declined transport. Signed AMA and EMS form. Significant other drove patient to ED for further evaluation. Received normal saline fluids, famotidine 40 mg PO x 1, hydroxyzine 25 mg IM X1, and Methylprednisolone 125 mg IM X1 in the ED. Discharged from ED 3/8/2021. Patient contacted on 3/11/2021 and states feeling a little better since visit to the ED on 3/8/2021. Still feels like throat and face are a little "tight" but improving.
66 2021-03-14 chest pain Shortness of breath, chest pain, chills, fatigue, pain in back, nausea - Went to ER Feb 28, 2am - sy... Read more
Shortness of breath, chest pain, chills, fatigue, pain in back, nausea - Went to ER Feb 28, 2am - symptoms continue for another week.
66 2021-03-14 lightheadedness felt like she was going to pass out; Dizziness and lightheaded/felt a heaviness in her head; get ach... Read more
felt like she was going to pass out; Dizziness and lightheaded/felt a heaviness in her head; get achy`; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (lot number was EL9262, expiration date was unknown) via intramuscular in left arm on 11Feb2021 around 10:00at single dose for preventative. Medical history included ongoing autoimmune condition diagnosed three years ago, ongoing primary biliary cirrhosis diagnosed three years ago, ongoing acid reflux diagnosed 5 years ago, blood pressure abnormal, cholesterol abnormal, cardiac disorder. She had one stent. Ongoing concomitant medication included ursodiol for autoimmune condition and primary biliary cirrhosis, simvastatin for cholesterol, ezetimibe (ZETIA) for cholesterol, losartan potassium for blood pressure, clopidogrel bisulfate (PLAVIX) since she had one stent, acetylsalicylic acid (BABY ASPIRIN) for the heart, hydrochlorothiazide for blood pressure, omeprazole for acid reflux. She received flu shot in Sep2020 or Oct2020 for immunization and she was fine. Patient received first dose of BNT162B2 (lot number was EL3249) via intramuscular in left arm on 21Jan2021 around 10:00 a.m. for COVID-19 immunization. Patient got something to eat and while she was on the phone around 12:30pm on 11Feb2021, she felt like she was going to pass out, she was dizzy and lightheaded. It lasted all night. On 12Feb2021 she felt a little better, but she still felt a heaviness in her head. It felt like pressure and the pressure was like dizziness. Her health care professional told her that it was normal, and she was told to hydrate, drink water and rest. She took her time getting up now since she was afraid. She wished she was one of the lucky ones to just get achy. Events not required visit to emergency room and physician office. There were no relevant tests. The outcome of event "Dizziness and lightheaded/felt a heaviness in her head" was recovering. The outcome of other events was unknown.
66 2021-03-16 chest pain 03/16/2021: Presented to the emergency department with chest pain. The patient was admitted for ches... Read more
03/16/2021: Presented to the emergency department with chest pain. The patient was admitted for chest pain observation. There are no acute ischemic ECG changes and her first 2 troponins are normal.
66 2021-03-16 platelet count decreased The evening after patient received vaccine, she started to develop low grade fever and urticarial ra... Read more
The evening after patient received vaccine, she started to develop low grade fever and urticarial rash at the vaccine site. The urticaria improved the following day, as did the fevers. Then 3/5, the fevers started again, several times per day, as high as 102 at home. In association with the fever she has had some mild nausea, x1 non-bloody emesis last night, as well as rigors/night sweats. She went to urgent care and eventually was admitted to the hospital for the following 9 days. During this admission, she continued to have fevers intermittently as high as ~103. She also developed more generalized urticarial rash (worst on trunk), and lab abnormalities including low platelets and elevated liver function tests. She had extensive testing, ultimately determined likely vaccine reaction, started on prednisone 40 daily and improved for discharge to home on 3/17 without fevers x48 hours and with improving labs.
66 2021-03-17 palpitations, heart rate increased Heart Racing/ elevated heart rate- several times a day. History of panic/anxiety attacks, but feels ... Read more
Heart Racing/ elevated heart rate- several times a day. History of panic/anxiety attacks, but feels completely fine, so the heart rate is concerning.
66 2021-03-17 palpitations, heart rate increased On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had ... Read more
On 3/4 approximately 24 hours after receiving first dose started shaking while standing as if I had parkinsons disease. The heaviest shaking was of the right arm and hand which was where the vaccine was administered. Made my way to bedroom on my walker to tell hubby I was not feeling well, Took blood pressure which was elevated and my heart felt like it was beating out my chest, Bllod pressure was elevated and so was pulse. Shaking continued and breathing was shallow, Waited 10 minutes and retook vitals, BP and pulse up more, Called 911, Paramedics came and monitored my vitals several times which after 20 minutes started declining, Could not say conclusively if was vaccine related. Elected due to Covid not to be transported to hospital and signed off on declination, Was told by paramedics to call 911 again if symptoms reoccurred and go to hospital, In successive days I still continue to have pin-prick feelings and numbness in my right fingers, More difficult to walk than usual,
66 2021-03-17 fainting Scared of needles. Syncope, flushing/sweating. BP 111/51 (pulse 90). Patient placed in supine positi... Read more
Scared of needles. Syncope, flushing/sweating. BP 111/51 (pulse 90). Patient placed in supine position - appeared to show signs of convulsion. Taken to the ED.
66 2021-03-17 palpitations heart racing, heartburn, have no energy
66 2021-03-18 pallor, loss of consciousness 12:45 Received Pfizer #2 13:00 Felt dizzy, lightheaded; consumed water and chocolate 13:05 Transport... Read more
12:45 Received Pfizer #2 13:00 Felt dizzy, lightheaded; consumed water and chocolate 13:05 Transported to EMS area of observation area; in wheelchair lost consciousness and had brief 15-20 second seizure 13:10 Repeated bouts of emesis. Patient had marked pallor and diaphoresis 13:35 EMS transport arrived, placed IV, gave phenergan, and transported via ambulance to Hospital Center
66 2021-03-18 pallor, blood glucose increased 1:50 pm patient complained of HA, dizziness, nausea. Provided water, elevated legs, observed x 5 min... Read more
1:50 pm patient complained of HA, dizziness, nausea. Provided water, elevated legs, observed x 5 minutes. Patient's color became very pale. EMS notified. Placed on O2 at 3L NP. SATS on RA 95%; after O2 improved to 98%. Initial VS 182/110 (2:05 pm); p 78; R. 30 - irregular. Glucose - 100dl BP 212/113; p 78. R 30. Nausea better. Sipping water. Refused food. 1415hrs. Fire/rescue arrives at 1420. Assessed patient. She initially refused transport, but later gave her consent. 1438 Transported to ER.
66 2021-03-18 blood pressure increased 3 days following the vaccine I felt as though my blood pressure might be elevated. I checked it sev... Read more
3 days following the vaccine I felt as though my blood pressure might be elevated. I checked it several times and it was over 200 (208, 212), so I sent to the ER where they did tests and found everything to be normal. BP dropped to 167 while there, so no medication was given. Advised to follow up with primary care doctor, which I did 2 days later. BP still in the 160s. Advised to monitor and if not improved to begin an additional BP medication.. That medication was started today. The vaccine was given through the County Health Department.
66 2021-03-18 cerebrovascular accident I had the second vaccine on February 13 in afternoon. I had a stroke causing expressive aphasia on ... Read more
I had the second vaccine on February 13 in afternoon. I had a stroke causing expressive aphasia on the evening of February 14. I had no side effects from the first vaccine and just soreness in arm of injection after the second vaccine. I realize that the stroke could coincidental but thought I should report it just in case for information in the event others had similar event.
66 2021-03-18 palpitations On 2/14 started experiencing heart palpitations, tremors, sweating No previous history of anxiety... Read more
On 2/14 started experiencing heart palpitations, tremors, sweating No previous history of anxiety or depression
66 2021-03-19 pulse abnormal, palpitations About 5 hours after receiving vaccine, a rash appeared on my torso and upper arms, prickly skin sens... Read more
About 5 hours after receiving vaccine, a rash appeared on my torso and upper arms, prickly skin sensation, thready pulse 80/min, felt occasional palpitations, Couldn't get accurate BP because it was faint and hard to hear pulse. I took Benedyl 25mg orally at 10 pm.
66 2021-03-21 ischemic chest pain About two hours after injection experienced heart pain. It lasted about 3 hours; This is a spontaneo... Read more
About two hours after injection experienced heart pain. It lasted about 3 hours; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in left arm on 06Mar2021 at 09:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included no thyroid, fibrinogen in blood; and known allergies to latex and penicillin. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), liothyronine, and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). On 06Mar2021 at 11:00 AM, the patient experienced about two hours after injection experienced heart pain. It lasted about 3 hours. There was no treatment given for the event. The patient recovered from the event on 06Mar2021 at 14:00. No follow-up attempts are possible. No further information is expected.
66 2021-03-21 pallor Patient was sitting s/p vaccination waiting 15 min. She became diaphoretic, nauseous, and pale. She ... Read more
Patient was sitting s/p vaccination waiting 15 min. She became diaphoretic, nauseous, and pale. She vomited twice. She stated that she thought she had a panic attack. Her vital signs were normal at all times. Last set of vitals 97.6 po, 126/84, 77, 98%
66 2021-03-22 deep vein blood clot, pulmonary embolism 2 days after vaccine she devloped symptoms of DVT and PE
66 2021-03-22 fainting I woke up after a normal night's sleep and found that everything was spinning. Was dizzy and could ... Read more
I woke up after a normal night's sleep and found that everything was spinning. Was dizzy and could not properly walk. After trying to drink a bit of water, fainted and vomited it all back up. I was weak and tired. Slept or rested all day and by late afternoon was able to hold down some toast and by evening symptoms had resolved. Clearly, I am not sure that this was vaccine related since it occurred 2 wks after vaccination but felt should be reported.
66 2021-03-22 hypertension Pt received the COVID vaccine 03/15/2021 at store. Per patient states that since then she has been h... Read more
Pt received the COVID vaccine 03/15/2021 at store. Per patient states that since then she has been having issues with blood pressure running high. Patient is on blood pressure medication but was stable and under control prior to vaccine .
66 2021-03-22 palpitations Racing heart, fatigue, headache, felt like fire bursts under my skin mostly in arms and legs. Had t... Read more
Racing heart, fatigue, headache, felt like fire bursts under my skin mostly in arms and legs. Had these adverse effects on and off for over a week. The second week after the shot felt numbness in my face. After about one month these events are mostly gone. Still have occasional fire bursts under my skin but only one or two not my entire arms or legs.
66 2021-03-22 heart rate irregular, atrial fibrillation Triggered atrial fibrillation within 4 hours after receiving 2nd dose. Double-loading Amiodarone for... Read more
Triggered atrial fibrillation within 4 hours after receiving 2nd dose. Double-loading Amiodarone for one week after speaking with doctor's office on 3/10/21 (3/10/21 - 3/16/21) and for another week (3/16/21 - 3/22/21) did not convert my heart back to normal sinus rhythm. During Kardia readings (taken 2-3 times per day), heart beat jumps back and forth repeatedly in the range of 92 to 110+.
66 2021-03-23 heart rate increased Received jab at 1:00pm ...at about 1:15 pm , exhibited extreme rapid pulse for 4-8 minutes. Pulse gr... Read more
Received jab at 1:00pm ...at about 1:15 pm , exhibited extreme rapid pulse for 4-8 minutes. Pulse gradually declined to a more normal range. Monitored by onsite nurse. Waited onsite for about 1/2 hour afterwards. Pulse normal.
66 2021-03-23 fainting Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred a... Read more
Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred around 8am on 3/24/21: Headache,Muscle pain, Chills, Joint pain, Fever, Nausea, Feeling unwell, Dizziness, Fainting
66 2021-03-24 blood pressure increased 1/13 vaccination I started having HA about 7pm that night. BP was elevated; 170/110. Kept monitoring... Read more
1/13 vaccination I started having HA about 7pm that night. BP was elevated; 170/110. Kept monitoring. Would come down every day. Valcartin increase per PCM and it took care of the BP increase after 3 days.
66 2021-03-24 heart rate increased Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and s... Read more
Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and swollen; raised red itchy rash on neck, chest and abdomen; swollen lymph glands in throat; diarrhea; sore throat; site soreness; achy joints; headache; nausea; fatigue; Racing heartbeat; throat felt lujeir was closing; tongue felt tingly and swollen; This is a spontaneous report from a contactable healthcare professional (the patient). A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205), via an unknown route of administration in the left arm on 06Mar2021 at 16:30 (at the age of 66-years-old) as a single dose for Covid-19 immunization. Medical history was included celiac sprue, Crohns, chronic pancreatitis, psoriasis, osteoporosis, and ulcerative colitis, all from an unknown date and unknown if ongoing. The patient was allergic to penicillin and codeine. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269) on 13Feb2021 at 11:30 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported however it was reported the patient had other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 16:30, within 5 minutes of injection, the patient experienced Racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands. The patient also experienced the typical side effects of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat, and raised red itchy rash on neck, chest and abdomen. Treatment of Benadryl was given for the events as recommended by paramedic which was still being taken on day 4. The clinical outcome of the events racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands was recovered on 06Mar2021 (reported as 'last about 10 minutes'); outcome of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat and raised red itchy rash on neck, chest and abdomen was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-03-24 atrial fibrillation Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable co... Read more
Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable consumer (patient). A 66 years old female patient (weight: 107.95 kg, height: 165 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 04Mar2021, at 16:50, for COVID-19 immunisation. Relevant medical history included atrial fibrillation from Jan2016 and ongoing and cardiac ablation on an unspecified date, in Feb2020 (she had her 2nd ablation in Feb2020, since then she has had intermittent episodes of atrial fibrillation. She stated prior to the second vaccine she had been in normal sinus rhythm for 8 days). Patient stated that she had a sister who had an arrhythmia problem. The patient previously, on 10Feb2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) in the left arm, at single dose, for COVID-19 immunisation. Patient stated that she had no problem with first dose. The patient received concomitant medications (unspecified). On 04Mar2021, at 21:00, the patient experienced atrial fibrillation and on 04Mar2021 she was tired. On 05Mar2021, she developed pain in the left arm. The patient recovered from pain in arm on 05Mar2021, from tiredness on 07Mar2021, while did not recover from atrial fibrillation. The information on the lot number has been requested.
66 2021-03-24 hypertension Within 10-minutes of vaccination, the patient reported dizziness when standing up. EMS evaluated the... Read more
Within 10-minutes of vaccination, the patient reported dizziness when standing up. EMS evaluated the patient on-site. The patient was hypertensive (159/88) with a FSBG of 89mg/dl. EKG demonstrated NSR, rate 61 bpm, no ST elevation. EMS transported the patient to Medical Center Emergency Department. In the ED, the patient denied vertigo symptoms. Labs were grossly unremarkable, but UA did have leukocyte esterase and bacteria. Physician considered 1g Rocephin for UTI, but did not administer due to hives reaction to amoxicillin. Prescribed the patient 5-days of Macrobid PO BID. Discharge diagnoses were lightheadedness and UTI.
66 2021-03-25 pulmonary embolism, nosebleed Principal Final Diagnosis: Acute saddle pulmonary embolism with acute cor pulmonale (HCC) Secondary... Read more
Principal Final Diagnosis: Acute saddle pulmonary embolism with acute cor pulmonale (HCC) Secondary Diagnoses: Active Hospital Problems Diagnosis Date Noted ? Acute saddle pulmonary embolism with acute cor pulmonale (HCC) 02/09/2021 ? Acute thrombus of right ventricle (HCC) 02/09/2021 ? Right-sided epistaxis 02/09/2021 ? Melena 02/09/2021 ? Essential hypertension 02/28/2020
66 2021-03-25 palpitations palpitations 24 hours after injection lasting several hours. Today is day 3 days since injection. Th... Read more
palpitations 24 hours after injection lasting several hours. Today is day 3 days since injection. This morning I noticed paresthesia of lips and face and tingling of lips and tongue. Beginning at 9 am and has continued through afternoon
66 2021-03-26 loss of consciousness Had expected body aches and chills during the night. Very lightheaded when I got up and some nausea.... Read more
Had expected body aches and chills during the night. Very lightheaded when I got up and some nausea. Thought to ?sit down before you fall down? then ?came to? next to toilet. Head resting on toilet seat. Had some bruising on cheek but don?t remember going to floor. Rest of day was okay with just the most common side effects. Never fainted before but not uncommon for me to be lightheaded with nausea. Most embarrassing...passed some stool.
66 2021-03-26 palpitations, chest discomfort Two hours post injection, experienced excessive, productive clearing of throat with a feeling of con... Read more
Two hours post injection, experienced excessive, productive clearing of throat with a feeling of congestion in chest which is still present. One week post injection could not sleep due to onset of frequent and bothersome cardiac palpitations with chest tightness which is still present at two weeks post vaccination.
66 2021-03-26 platelet count decreased high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and se... Read more
high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and severe pain and weakness.
66 2021-03-27 body temperature decreased Approximately 32 hours after injection, I began to feel severe gastric bloating. The diarrhea began ... Read more
Approximately 32 hours after injection, I began to feel severe gastric bloating. The diarrhea began soon after, and then vomiting. Both projectile (I know, eww). I experienced this every 30-60 minutes for about 7 hours. Then the nausea subsided, and the episodes of diarrhea began to happen at longer intervals. I also experienced cold sweats and the next day my body temperature was reading low (96.4 at one point). My brain fog and weakness were probably the result of dehydration.
66 2021-03-28 ischaemic stroke Patient presented to the ED on 3/4/2021 with left facial droop, left-sided weakness, and dysarthria ... Read more
Patient presented to the ED on 3/4/2021 with left facial droop, left-sided weakness, and dysarthria that started upon awakening that morning. Patient found to have an ischemic stroke and ultimately admitted to hospice. Patient expired on 3/10/2021.
66 2021-03-28 palpitations, heart rate increased peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination;... Read more
peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
66 2021-03-28 blood clot phlebitis in my Right leg; small blood clot; This is a spontaneous report from a contactable nurse (... Read more
phlebitis in my Right leg; small blood clot; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 09Feb2021 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history included many allergies. The patient has no COVID prior to vaccination. The patient had other medications in two weeks but no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9263) on 20Jan2021 at 10:00 administered in the right arm for Covid-19 immunization. On 20Feb2021 at 12:00 (also reported as "in February"), the patient had a phlebitis in her right leg, a week later (Feb2021) a vascular surgeon office did an ultrasound and found a small blood clot. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with Eliquis BID (twice a day) for 45 days. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered.; Sender's Comments: A causal relationship between BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the event thrombosis cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .
66 2021-03-30 cardiac failure congestive, cardiac arrhythmia Acute on chronic systolic congestive heart failure; PVC's (premature ventricular contractions); SOB ... Read more
Acute on chronic systolic congestive heart failure; PVC's (premature ventricular contractions); SOB (shortness of breath)
66 2021-03-30 chest pain, blood pressure increased Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders an... Read more
Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders and front/top head; Weakness in arms right worse than left; Tingling in right hand; Nausea; Salty taste in mouth; Elevated blood pressure; Dry mouth; Indigestion; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm at the age of 66-years (non-pregnant at the time of vaccination), on 01Feb2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history included osteopenia and allergies to PCN (penicillin) and latex. Concomitant medication included glucosamine, curcuma longa (TURMERIC [CURCUMA LONGA]), fish oil (OMEGA 3 [FISH OIL]), calcium citrate (CITRACAL [CALCIUM CITRATE]), colecalciferol (VIT D3), cranberry, and biotin. The patient previously took first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm at the age of 66-years, on 13Jan2021 at single dose for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. The patient experienced pressure in head & face, pains in nape, across the shoulders and front/top head, weakness in arms right worse than left, tingling in right hand, nausea, salty taste in mouth, elevated blood pressure, dry mouth, and indigestion on 05Feb2021. The patient also experienced chest pain on 10Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement on 05Feb2021: elevated; nasal swab on 11Feb2021: pending result. The patient received paracetamol (TYLENOL) and ibuprofen (ADVIL) as treatment for the events. The patient also used heating pad and icepack as treatment for the events. The outcome of the events was not recovered.
66 2021-03-30 cardio-respiratory arrest Jerking movement were to hands when observed during med pass. Tonic clonic movements were assessed ... Read more
Jerking movement were to hands when observed during med pass. Tonic clonic movements were assessed for approximately 2 minutes. Code called and patient sent to ER via 911 No history of Seizures she has ongoing seizures. there is a significant decline in her mental status. She is not speaking. She has to be fed. She is not walking.. She is scheduled to see a neurologist in June 2021.
66 2021-03-30 heart rate increased, blood pressure decreased, palpitations drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart... Read more
drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart beat; no appetite; exacerbation of existing neuropathy; Palpitations; being lightheaded; sweating; burning mouth syndrome; burning mouth syndrome; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; Some of my reactions look like an allergic reaction; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 66-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3302, expiry date not reported) via an unspecified route of administration, administered in left arm on 11Mar2021 14:00 at a single dose for COVID-19 immunisation. Medical history included neuropathy from 2006 and ongoing, since she had chemotherapy in 2006 for breast cancer in 2006 and burning mouth syndrome. The patient had no covid prior vaccination. The patient had no known allergies. The patient had other medications in two weeks which included unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient previously took doxycycline from 2010 to an unknown date for Lyme's diseaseand experienced burning mouth syndrome. On 11Mar2021 at 02:00 PM, patient had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. These symptoms still continue. Patient stated that people were talking about the second dose being worse. Patient stated that some of the reactions in Mar2021 look like an allergic reaction. They (HCP) only have cautioned the patient about difficulty breathing in Mar2021. They were saying there wasn't anything they can do for it. Patient asked how long the side effects will last and how to go about changing the appointment. If they are going to continue, patient was very concerned about following up with the second shot and asked if they can have that second shot be postponed until patient was not experiencing these side effects to the effect that she was. She completed the self-reporting on Monday (15Mar2021), but because her side effects were not going away she wanted to reach out to someone. She has reached out to her practitioner and had an appointment yesterday. Doctors didn't really know because it was all very new. She had the first vaccination shot on 11Mar2021, almost a week ago. In the 15 minutes that she waited afterwards she definitely experienced palpitations and a feeling of lightheadedness. She has an underlying condition of burning and pain called neuropathy. She has had neuropathy since she had chemotherapy in 2006 for breast cancer. This exacerbated that. She had been very concerned about that prior. Everyone said and the CDC recommends even with neuropathy to go ahead with the vaccine. It also triggered another underlying condition. She had a reaction to a course of Doxycycline in 2010 for Lyme's disease that caused burning mouth syndrome. Both of these things were really acute now, the neuropathy and burning mouth syndrome. Monday (15Mar2021) was a particularly bad day because the symptoms of an allergy which were swelling of the face and throat, fast heart beat, and dizziness were with the burning mouth syndrome. She didn't have difficulty breathing. It was the nerve endings of the tongue that go all the way to the back of her throat and gave the sensation of the whole mouth being involved. Monday was difficult. It was 8 hours of an acute episode then it eased off a little that evening. She had no appetite on Monday and barely ate anything. Yesterday was ok and much better although she was being triggered by environmental thing such as food and toothpaste. Things she normally uses were setting it off. She had an acute reaction this morning to a protein shake she has had every day for 14 years. The reaction this morning, 17Mar2021, was a drop in blood pressure and palpitations. It passed. She has been documenting this and made her provider aware of what she was experiencing. She was participating in the V-Safe through the CDC that checks up on her everyday and asks about symptoms. She didn't know if she was supposed to report this to the vaccine adverse event system or not. Obviously, she didn't want to get COVID. She was struggling with the recommendation to get second shot because she was extremely concerned. She wanted to know how long will the side effects will last and if she can postpone getting the second shot until she gets reasonably well. No practitioner can recommend whether to do it or not to do it. She reported this information online to Pfizer on 15Mar2021. She provided the lot number when she reported it online. The patient was not tested for COVID post vaccination. No treatments received from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The patient recovered with lasting effects from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The outcome of the other reported events was unknown.
66 2021-04-01 cerebrovascular accident Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous re... Read more
Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 13Feb2021 14:00 (lot number: EL9264) as single dose at the age of 66 years old, for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, spinal stenosis, arthritis and allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included insulin human zinc suspension (HUMULIN U), metformin, pioglitazone hydrochloride (ACTOS), fish oil, tocopherol (OMEGA 3) and valsartan; all taken for an unspecified indication, start and stop date were not reported. The patient previously took bydureon, codeine and celebrex and experienced drug allergy with these medications. The patient previously received first dose of bnt162b2 on 23Jan2021, at the age of 66 years old for COVID-19 immunization (Product: COVID 19, brand: Pfizer BIONTECH, lot number: EL3247, administration time: 03:00 PM, vaccine location: right arm). The patient did not receive any other vaccines four weeks prior to COVID vaccination. The patient had a stroke with expressive aphasia on 14Feb2021 20:00. The patient was hospitalized due to stroke with expressive aphasia for 5 days. The events resulted in emergency room/department or urgent care and hospitalization. On unspecified dates, the patient underwent lab tests and procedures which included computerised tomogram (CTS), laboratory test (labs), magnetic resonance imaging (MRI), and tPA (plasminogen activator inhibitor); all with unknown results. Other tests include: negative COVID test (nasal swab) on 16Feb2021 and negative COVID test (blood test) on 03Mar2021. The patient had speech therapy as treatment for the events. The patient recovered with sequelae from the events.; Sender's Comments: The reported stroke with expressive aphasia is assessed as unrelated to the administration of vaccine BNT162B2 and can be explained as intercurrent medical condition in this elderly patient with underlying diabetes mellitus, hypertension and other comorbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
66 2021-04-01 platelet count decreased low platelets- 10k; This is a spontaneous report from a contactable physician. A 66-year-old female ... Read more
low platelets- 10k; This is a spontaneous report from a contactable physician. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at a single dose, for covid-19 immunization. Medical history included allergies: penicillins and, ICD-10 C24.1 ampulla of vater cancer. The patient's concomitant medications were not reported. The patient previously took levofloxacin and experienced allergies. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The patient developed low platelets- 10k on 19Feb2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone 20mg as treatment. The outcome of the event was unknown. It was unknown if the patient was covid-tested post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event platelet count decreased cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
66 2021-04-01 cerebrovascular accident stroke; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female pat... Read more
stroke; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266 and expiration date not reported) via an unspecified route of administration, administered in the left arm on 24Feb2021 16:15 as a single dose for COVID-19 immunisation. Medical history included LBBB, HTN, and high cholesterol. The patient is not pregnant and has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had the first dose of the vaccine on 24Feb2021 and had stroke on 09Mar2021 16:00 with no CVA history. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized on an unspecified date for the event for 1 day. Treatment was given in response to the event which included CT Scan and MRI. The patient underwent COVID test post vaccination via nasal swab on 09Mar2021 and was negative. The outcome of the event was recovering. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6208) on 17Mar2021 for COVID-19 immunization.
66 2021-04-06 blood clot, cerebrovascular accident She had a stroke on 3/28/2021 due to a blood clot in her brain; She had a stroke on 3/28/2021 due to... Read more
She had a stroke on 3/28/2021 due to a blood clot in her brain; She had a stroke on 3/28/2021 due to a blood clot in her brain; Administration_date=08/03/2021 number=1/administration_date=22/03/2021 number=2; Administration_date=08/03/2021 number=1/administration_date=22/03/2021 number=2; This is a spontaneous report from a contactable consumer reporting for herself. A 66-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 22Mar2021 17:45 (vaccinated at the age of 66 years old) as single dose for covid-19 immunisation. Patient received the first dose on 08Mar2021. Medical history included diabetes; obesity; high blood pressure, iodine allergy. The patient's concomitant medications were not reported. The patient experienced she had a stroke due to a blood clot in her brain on 28Mar2021 18:30, The patient was hospitalized for she had a stroke due to a blood clot in her brain (cerebrovascular accident) for 2 days. Patient visited Emergency room/department or urgent care for events a stroke due to a blood clot in her brain and received treatment. Outcome of event a stroke due to a blood clot in her brain was not recovered. Information about lot/batch number requested.
66 2021-04-08 chest pain Presented with chest pain and found to have Takotsubo cardiomyopathy
66 2021-04-11 loss of consciousness My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and dia... Read more
My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot.
66 2021-04-12 chest pain, atrial fibrillation four days after second shot, severe stomach pain, fevers, trouble urinating, chest pain, . turned in... Read more
four days after second shot, severe stomach pain, fevers, trouble urinating, chest pain, . turned into kidney infection, blood infection and having AFIB, need for pace paker.
66 2021-04-14 cerebrovascular accident Patient is deceased. Had a blood clot travel to her brain and causes an un recoverable stroke
66 2021-04-14 blood clot, atrial fibrillation Severe abdominal pain,nausea,emergency hospital visit,atrial fibrillation,thrombosis,left.kidney inf... Read more
Severe abdominal pain,nausea,emergency hospital visit,atrial fibrillation,thrombosis,left.kidney infarct.admittance to local hospital for 5 days and ongoing follow up testing and multiple specialist visits for months
66 2021-04-15 cerebrovascular accident Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 a... Read more
Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 am. Continued to 4:30 am on April 10. Slight elevated temperature at 99.1 . On morning of April 11 couldn't put pressure on right side, leg and arm, facial numbness. Went to er and they said I was having a stoke, transferred to hospital. MRI done verified Stroke with blood clot to Left thalamus Sent home and will be receiving PT and OT.
66 2021-04-15 cerebrovascular accident experienced a stroke three days after receiving the first Pfizer shot and was treated at Hospital.
66 2021-04-16 transient ischaemic attack Hospitalized with a TIA (transischemic attack) slurred speach, cognitive abilities effected, left-si... Read more
Hospitalized with a TIA (transischemic attack) slurred speach, cognitive abilities effected, left-sided weakness
66 2021-04-17 blood pressure increased Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning s... Read more
Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; BP 183/90; This is a spontaneous report from two contactable consumers (one is the patient). A 66-year-old female patient (no pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), in left arm on 09Mar2021 at 13:00 (at the age of 66-years-old) at single dose for COVID-19 immunization. Medical history included known allergies at lemon, lime, green peppers, mushrooms, walnuts, sleep apnea, asthma, obesity, anxiety/antidepressants for 35 years from 1986. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), tiotropium bromide (SPIRIVA), albuterol (salbutamol), duloxetine hydrochloride (CYMBALTA), colecalciferol (D3), ascorbic acid (C), antidepressants. The patient previously took furosemide and theophylline and experienced allergies. The patient experienced numbness on the left side of the face, started 25 minutes after the injection, on 09Mar2021 at 13:30 and resolved fully within 30 hours. ER visit immediately. MRI showed nothing. Blood pressure (BP) 183/90. Left side of face hot, red, and a mild burning sensation on 09Mar2021 at 13:30. Diagnosis bells palsy probably. Follow up visit to the doctor concurred. The events resulted in emergency room/department or urgent care; no treatment was received for the events; no Covid prior vaccination; no Covid tested post vaccination. No other vaccine in four weeks. The patient had recovered from the events on 10Mar2021.
66 2021-04-17 heart rate abnormal, chest pain, heart attack Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurt... Read more
Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Unable to lift arm, pain makes her catch her breath/ Difficult to take a deep breath; Thought she was having a heart or panic attack; Stress, heart rate, panic; soreness from the shot; Stress, heart rate, panic; Stress, heart rate, panic; Stress, heart rate, panic; Tingling in hands and down the arm; crying; This is a spontaneous report received from contactable consumer (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 66-years-old on 22Mar2021 13:57 (Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included topiramate taken for migraine from 15Mar2021 and ongoing. The patient had her shot last Monday afternoon and had some soreness from the shot on Mar2021. On Tuesday, 23Mar2021, it began getting sore back behind her shoulder blade; it has gotten progressively worse, and now she can barely lift her arm. She does not know if it's a muscle or has to do with the vaccine, or if she pulled a muscle although she has not done anything. It's difficult to take a deep breath, she can't lift her arm, it is sore. It hurts down into her chest and around her breast; also, hurts around on her back where her shoulder blade is. She has tried heat compress, cold compress, and massage the area. It seems like the pain will ease up but then it starts again. She becomes stressed about it and her heart rate starts panicking. She gets tingles down the arm. Thought she was having a heart or panic attack. It has gotten worse as the week has progressed. It was worse on Sunday; even worse on Monday; worse yesterday and she was crying. She has also been stressed at work. Doesn't know whether to go to the doctor or an urgent care, or if she needs to. The patient is 66 years old and says she is in fairly good health. Right now she is unable to lift her arm and has tingles in the hand and down the arm. The pain makes her catch her breath. If this gets much worse she is going to go have it checked out. Again mentions that she has been having stress. It does seem to be a little worse. The patient experienced thought she was having a heart or panic attack on Mar2021, stress, heart rate, panic on Mar2021, soreness from the shot on Mar2021, soreness to left arm, hurts in chest around breast, back, shoulder blade on 23Mar2021, unable to lift arm, pain makes her catch her breath/ difficult to take a deep breath on Mar2021, tingling in hands and down the arm on Mar2021, and crying on Mar2021. The outcome of the event Soreness to left arm, hurts in chest around breast, back, shoulder blade was not recovered while for the rest of the events was unknown. Prior Vaccinations (within 4 weeks) was None. She had an unspecified shot but reiterated no vaccines. No AEs following prior vaccinations.
66 2021-04-18 deep vein blood clot Unprovoked Calf DVT in low risk patient
66 2021-04-24 blood clot blood clot in her right ankle; varicose vein in her right ankle and it started to hurt; varicose vei... Read more
blood clot in her right ankle; varicose vein in her right ankle and it started to hurt; varicose vein in her right ankle and it started to hurt; ankle on her right side started swelling; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on arm left on 26Feb2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809 and expiry date: 30Jun2021) on left arm on 05Feb2021 for covid-19 immunisation. The patient experienced blood clot in her right ankle, varicose vein in her right ankle and it started to hurt, ankle on her right side started swelling, all on an unknown date. All events caused patient physician office visit. Treatment received for all events. It is reported that she is calling about the Covid 19 vaccine. She wanted to report that she developed a blood clot in her right ankle. She went to the doctor yesterday on 06Apr2021. She would like to add she has no prior history of any type of blood issues. The doctor she saw thought that the blood clot and the Covid 19 vaccine could be related but would not commit to saying so directly. She started having issues about 6 days after the second Covid 19 vaccine. She doesn't exactly remember when, maybe the 04Mar2021 or 05Mar2021. She ignored the issues attributing them to over exercising. She reached a point where she couldn't ignore the issues anymore and went to the doctor. Caller clarifies she has a varicose vein in her right ankle and it started to hurt then her ankle on her right side started swelling. She only payed attention to her ankle when it got worse. The last 3 weeks have been awful. She would like it known that she does not lead a sedimentary lifestyle. She rides her bike 60 miles a week and walks 10 miles a week. She's always moving. This is unusual for her. The doctor she saw diagnosed her with a blood clot and he did a sonogram in his office. She has been prescribed Xarelto 15mg tablets. Take 2 tablets twice daily for the first 21 days then on the 22nd day start taking one 20mg tablet once daily. The patient underwent lab tests and procedures which included sonogram: unknown result on 06Apr2021. The outcome of the all events was unknown.
66 2021-04-26 body temperature decreased Temp dropped to 94.3; Had a very sore arm for two days; swelling in gland under the arm; Strong head... Read more
Temp dropped to 94.3; Had a very sore arm for two days; swelling in gland under the arm; Strong headaches were common & continue; She had lost a week of her life trying to keep warm; This is a spontaneous report received from a contactable other healthcare professional (patient). A 66-year-old female (non-pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration in left arm on 10Feb2021 at 09:00 AM (at the age of 66-years-old) as a single dose for COVID-19 immunization in Public Health Clinic/Veterans Administration facility. Medical history included allergic to dust, mold, mildew, hay, cat & rabbit hair. Concomitant medications included atorvastatin, cetirizine, amlodipine, all received in two weeks. No other vaccines received in four weeks. The patient previously took moxifloxacin hydrochloride (AVALOX) and had allergies (Bayer wide spectrum antibiotic). The patient had not been tested for COVID prior vaccination. It was reported that 10 hours after receiving the vaccine Temperature dropped to 94.3 on 10Feb2021 at 08:00 PM. For next 8 days it has varied as sub-normal from 95 to 97.6, mostly ranging from 95.4 to 96.5. Had a very sore arm for two days with swelling in gland under the arm. Strong headaches were common & continue. Eight days out that swelling is still going down. The doctor visit was a waste of time & money. They knew little & couldn't offer any suggestions. She was afraid to get the second shot because the doctor did tell her side effects would be worse with that one. She had lost a week of her life trying to keep warm. Her temperature did go up to normal & past on day 8 after she was in a very hot vehicle for 1/2 hr. Events resulted in visit to Doctor or other healthcare professional office/clinic. No treatment received for events. The patient had not been tested for COVID post vaccination. The outcome of events was recovering. Information on lot/batch number has been requested.
66 2021-04-26 loss of consciousness nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels li... Read more
nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Constipated; Doesn't sleep through the night; Headache lasted for days and days; No appetite, lost 6 pounds in a week; No appetite, lost 6 pounds in a week; Tired; Diarrhea; Nausea; felt like Dumping Syndrome; Stiff neck, like an iron claw; Anxiety reared up; Blacked out; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 17Mar2021 at 11:30 AM (at the age of 66 years old) (Lot Number: EN6205, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included ongoing anxiety (40 years or more), ongoing depression (46 years ago, at the age of 20), ongoing acid reflux (maybe 25 years), ongoing GERD (maybe 25 years), ongoing Barrett's esophagus (for 12 years), mild to moderate COPD since 2011, gastric bypass (a year and a half ago), and lost 120 pounds. Concomitant medications included bupropion for anxiety depression and omeprazole for acid reflux, both ongoing. The patient previously received flu and tetanus on unspecified dates for immunization and both experienced hard red welt on arm (welt was hard and lasted for 5-7 days). The patient reported no side effects for 12 hours, but a little soreness at injection site on 17Mar2021 at 20:00 (8:00 PM). Her arm wasn't heavy, but she had an awareness of the soreness. She has had life-long anxiety and depression. Several weeks ago (on 26Mar2021), her anxiety reared up, and it could have been due to a family situation. On the 9th day after the first shot, she was having a therapy appointment on the phone and talking about her anxiety, and she got a stiff neck, like an iron claw (26Mar2021 at 10:00 am). It lasted for a couple of 5 minutes and she laid down on the couch then on the floor. Her therapist said to call 911. Emergency medical technicians came to her house and they said all of her numbers looked good. She went to the hospital, and was in the emergency room for several hours, but she only remembers one hour of it. She also had diarrhea and nausea on 26Mar2021 at 11:30, and it felt like Dumping Syndrome, that one can have from a gastric bypass. She was only aware for one hour at that point and blacked out (on 26Mar2021). With regards to nausea, she mostly saw bile in the bag, all she had that day was a protein drink. She was back home and the next day, she did not remember how she got home. She hasn't had blackouts anymore but feels it may be from heightened anxiety. On 27Mar2021 at 09:00, she had no appetite, lost 6 pounds in a week, and was tired. She had headache lasted for days and days on 29Mar2021 at 09:00 AM. She is slowly improving but she still doesn't sleep through the night on 29Mar2021 at 16:00. It was like a feeling like she was resetting her surgery, like she didn't care about eating. The also experienced back pain, butt and legs hurt, feels like sciatica on 31Mar2021 at 16:00 and was constipated. She is using a stool softener and is back in her routine. She called her primary doctor and could not tell her what happened, and she went in a loop trying to get information and authorizations for her to make a determination of what had happened. Her doctor felt like she should have an MRI. Her heart and all of her numbers looked good, as the emergency medical technicians said. Her primary doctor recommended her to get the second shot. She had cancelled the second shot for this week, and she has rescheduled it for another date. She was afraid that she will black out again, after the next vaccine, and is not sure if that is how her anxiety manifested. The main reasons she is calling is that she had no concerns of side effects prior to the vaccine, and a couple of her neighbors said they had read about side effects of the vaccine, but she was not worried. When the patient started to read about side effects of the vaccine, she understood that on the 10th day, the vaccine starts to be in a person's system and that maybe is why she didn't have initial side effects, but then she had side effects several days later because the vaccine was in her body. By day 10, the vaccine is in effect in the body and she is nervous. Her second vaccine is scheduled on 26Apr2021. The patient would like to know if there is any information on people that have had a gastric bypass. The patient has no prior vaccinations within 4 weeks. The events resulted in emergency room visit (except nervous). The patient recovered from soreness at injection site on 18Mar2021; recovered from diarrhea, nausea, felt like Dumping Syndrome on 26Mar2021; recovered from stiff neck on 26Mar2021 at 10:05am; recovered from constipation on 02Apr2021; and recovered from no appetite and lost 6 pounds on unspecified dates. The patient also recovered from headache with sequelae on unspecified date; and recovered from blacked out on 27Mar2021 with sequelae. The patient had not yet recovered from anxiety reared up; tired; doesn't sleep through the night; back pain, butt and legs hurt, feels like sciatica. No follow-up attempts are possible. No further information is expected.
66 2021-04-30 blood pressure increased flushed hot face; sweaty head; BP 160/90; This is a spontaneous report from a contactable consumer, ... Read more
flushed hot face; sweaty head; BP 160/90; This is a spontaneous report from a contactable consumer, reporting for herself. A 66-year-old non-pregnant female patient received the second dose (Lot Number: ER8732) of the bnt162b2 (BNT162B2), via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included sleep apnea, asthma, obesity, anxiety (antidepressants for 35 years), and allergy to lemon, lime, green peppers, mushrooms, walnuts. Concomitant medications included fluticasone furoate/vilanterol trifenatate (BREO ELLIPTA); tiotropium bromide (SPIRIVA); albuterol [salbutamol] (MANUFACTURER UNKNOWN); duloxetine hydrochloride (CYMBALTA); vitamin d3 (MANUFACTURER UNKNOWN); vitamin c [ascorbic acid] (MANUFACTURER UNKNOWN). The patient previously received furosemide (MANUFACTURER UNKNOWN) and theophylline (MANUFACTURER UNKNOWN) and experienced drug allergy to both on unspecified dates. The patient previously received the first dose of the bnt162b2 (Lot Number: EN6206) on 09Mar2021 13:00 at a single dose in the left arm at 66 years of age for covid-19 immunisation. There were no other vaccinations within 4 weeks prior to vaccination with bnt162b2. There was no covid-19 prior to or post vaccination with bnt162b2. On 30Mar2021 at 14:00, the patient experienced 30 minutes after shot, while still sitting in the post-shot waiting area: flushed hot face, sweaty head, BP 160/90, which were non-serious. BP was 130/72 just before going to the get the shot on 30Mar2021. There was no therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered after about 30 minutes on an unknown date. The patient fully recovered within an hour. No follow-up attempts are needed. No further information is expected.
66 2021-05-04 chest discomfort Anaphylaxis reaction immediately post-vaccine; Difficulty speaking; hoarseness; tightness in throat ... Read more
Anaphylaxis reaction immediately post-vaccine; Difficulty speaking; hoarseness; tightness in throat and chest; tightness in throat and chest; dizziness; disorientation; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 as single dose for covid-19 immunization in an hospital. Medical history included reaction to preservatives in foods, products, and medications from an unknown date. The patient's concomitant medications were not reported. The patient previously took sodium metabisulfite and experienced anaphylaxis. No other vaccines taken in four weeks. No COVID-19 prior to vaccination. On 08Mar2021 18:00 the patient experienced anaphylaxis reaction immediately post-vaccine, difficulty speaking, hoarseness, tightness in throat and chest, dizziness, and disorientation. The events required emergency room and physicians office visit and were considered life threatening by the reporter. The patient was treated with Epinephrine, Benadryl, Prednisone, and Pepcid. The patient was tested for COVID-19 via nasal swab post vaccination on 08Mar2021 with a negative result. The outcome of the events were recovered with sequel. Information about lot/batch number has been requested.
66 2021-05-04 heart flutter, palpitations Caller reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the ... Read more
Caller reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin.; Caller reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin.; Heart palpitations, heart fluttering; Heart palpitations, heart fluttering; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8730), single dose, dose 1 via an unspecified route of administration, administered in the right arm on 31Mar2021 at 09:30 (at the age of 66 ears-old) for COVID-19 vaccination. Medical history included hip arthroplasty from 21Nov2020 to an unknown date. Historical vaccine included felt like she had the flu and was down for a few days after she got the flu vaccine. Family Medical History Relevant to the adverse events included her aunt passed away from taking penicillin years ago but does not specify that she has an allergy herself. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On There were no additional vaccines administered on the same date of the Pfizer suspect. The patient experienced heart palpitations, heart fluttering on 31Mar2021, reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin on 04Apr2021. She felt was down for a few daysThe events did not require an emergency room or physician's office visit. The patient used moisturizer and Vitamin E oil for the rash. The clinical outcome of heart palpitations and heart fluttering was not recovered and recovering for rash and dry skin. . .
66 2021-05-07 deep vein blood clot deep vein thrombosis left leg/Vascular u/s showed clot from the ankle to the groin in left leg; This... Read more
deep vein thrombosis left leg/Vascular u/s showed clot from the ankle to the groin in left leg; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation, administered at the hospital. Medical history included prediabetes, relapsing polychondritis, obesity, intolerant to gluten and cow's milk protein, and penicillin allergy. The patient is not pregnant at the time of report and vaccination. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included fish oil; ergocalciferol (VIT D); methylfolate; metformin; and desvenlafaxine succinate (PRISTIQ). On 12Jan2021 at 19:00, the patient's left ankle swelled double normal size. On 13Jan2021, left leg swelled. On 14Jan2021, patient knew it was a deep vein thrombosis left leg based on pain and swelling and past experience but waited till her day off on 15Jan2021 to seek medical care. Vascular u/s (ultrasound) on 15Jan2021 showed clot from the ankle to the groin in left leg. Sent to emergency department and started on Zarelto x 6 months for long term anticoagulation. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the second dose on 01Feb2021 at 16:45. Outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event deep vein thrombosis and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
66 2021-05-10 platelet count decreased Developed left sided neck swelling 1 day after vaccination. Left sided neck swelling was associated ... Read more
Developed left sided neck swelling 1 day after vaccination. Left sided neck swelling was associated with lymphadenopathy. Persisted for 3 weeks before spontaneously improving. Patient also developed a rash (biopsy confirmed leukocytoclastic vasculitis) about 2 weeks after vaccination, which persisted 5 days before resolving.
66 2021-05-12 chest pain pleurisy symptoms/pain couldn't turn over, couldn't take a deep breath; fever; arm was really sore; ... Read more
pleurisy symptoms/pain couldn't turn over, couldn't take a deep breath; fever; arm was really sore; pain in her chest whenever she would take a deep breathe; This is a spontaneous report from a contactable Nurse (patient). A 66-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EN5318, Expiration date unknown) at 10 AM via an unspecified route of administration on 04Feb2021 at 10:00 as single for covid-19 immunization. Medical history included ongoing Psoriatic arthritis and first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: EL8982, Expiration date unknown) via an unspecified route of administration on 14Jan2021 for Covid-19 immunization and minimally sore arm. Concomitant medication included methotrexate (Injection) at 0.4 mL, weekly taken for Psoriatic arthritis. It was reported that, pain in her chest whenever she would take a deep breathe and described the symptoms as pleurisy symptoms on an unspecified date in 2021. Stated that the pain has "definitely subsided and it was gone within a week. Reports that her oxygen saturations were lower than normal, and stayed around 94%. With her second injection she had what she thought was some interesting side effects from the vaccine. She says the first one she got she only had a minimally sore arm, she got that first one on the 14Jan2021 and then got the second vaccine on 04Feb2021 and the first 24 hours her arm was really sore on an unspecified date in 2021, but she thought that was nothing to worry about. She got the second dose at 10 am and the next day after 10 AM at about 1 or 2PM she noticed that it was sore for her to take a breath and she thought hmm okay. That night she had a low grade fever which she expected and she took Tylenol. On an unspecified date in 2021, the next morning she woke up Saturday at 5 AM in severe she pain couldn't turn over, she couldn't take a deep breath, she had fever of 102, she managed to get up and she took Tylenol and she had to sit in a chair, she couldn't take a deep breath. She was not short of breath, she just couldn't expand her lungs and she went to a clinic at about 3PM because she was scared she had a pulmonary embolism, they did a chest x-ray and didn't see anything, and they said it sounds like pleurisy, she has never had that in her life ever and they just gave Toradol and said if it gets worse come back the next day or if it does not go away come back Monday. She says it did not end up getting better she was the same way the next morning. Her O2 sats were staying around 94 which was not bad but for a healthy person they should be a little but higher than that, but she couldn't take a deep breath. She says that Monday she thought maybe she got Corona and didn't know it so she went back to the Clinic and asked for a test and she tested negative for the corona virus and they just said they did not feel like it was vaccine related. They sent her home and did not do anything else. It took her until Friday of the week after the vaccine. She says she got the vaccine on a Thursday and on Friday she started feeling bad and it took until the following Friday and Saturday to be fever free and feeling like a human being. She has been on hold for 2 hours so she can answer some questions. She confirm it was the second dose that she was calling about. She got the second dose 04Feb2021 and she had minimal slight soreness when she took a deep breath starting the next day. She says it did not present it self as sever until 5 AM the next morning after she had been asleep all night. She says initially it was pain in both sides of her chest but it wound up setting on the right side, the right lung, she says she keeps saying lung but it she would say right chest. She takes Methotrexate injection once per week for psoriatic arthritis and she contacted her rheumatologist and he okayed her to get the vaccine. She says it was a small dose. It comes in bottle of 50 mg per 2ml and she only takes 0.4 ml once weekly. She has been on it for about a year and half. She would says it was medically significant because she doesn't normally get ill with anything hardly. She does not even go to the doctor but once per year to get a check up. She asks has anyone else reported symptoms like this, pleurisy like symptoms. She asks if it was not long she would be interested to see. The outcome of the events was unknown and Causality was reported as related. Follow-up activities completed. No further information expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pleurisy and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
66 2021-05-13 chest pain Aching on left side of her chest/ achy on the left side of her chest; Shortness of breath where it w... Read more
Aching on left side of her chest/ achy on the left side of her chest; Shortness of breath where it was hard to get a deep breath; This is a spontaneous report from a contactable consumer or other non hcp (the patient reported for herself). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/ lot number: EL9261. Expiry date: UNKNOWN) via an unspecified route of administration, in the region of left arm on 21Jan2021 at 12:20 (At the age of 66-years-old) as 0.3 mL, single for COVID-19 immunisation (reported as virus protection). Medical history was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect and any additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. No Prior vaccination within 4 weeks of the vaccination. On 23JAN2021, the patient experienced aching on left side of her chest, shortness of breath where it was hard to get a deep breath. Patient was advised by her doctor to call and report the side effects that she has experienced since receiving the first dose of the Covid-19 vaccine. Patient went to the emergency room on 27Jan2021 due to the events, Aching on left side, shortness of breath. They were unable to find anything wrong with her heart. She did not have any blood clots. She also had an X-ray of her lungs. Because of these symptoms she had a COVID test on 23Jan2021 at the urgent care. The test was negative. She may have been exposed to COVID on 01Jan2021. Her next dose is 11Feb2021. She wants to get the second dose. Her doctor said she needs to speak with Pfizer for recommendations about the next dose. Both the events were reported as ongoing. The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.
67 2021-01-03 blood pressure increased, heart rate increased Blood pressure and pulse rate increased to 164/64, 85
67 2021-01-03 oxygen saturation decreased, skin turning blue On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, e... Read more
On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, etc.). Noticed some circumoral cyanosis around my lips after arriving home. Had a fine afternoon (sleeping following vaccine and 16 hr. shift). Had dinner and usual evening. Upon going to bed about 11pm, I experienced chills for several hours, and shortness of breath. Very weak. Called 911 about 3 am - went to hospital ER - O2 sat. 90% enroute. Vital signs stable in hospital ER. Had neg. CXR, EKG, and labs. Also had slight cough and slight bronchial congestion. Received some IV fluids in ER. Left ER at 7am. Went home and slept all day, slight nausea in am. Awoke at 7pm - had good breakfast for dinner. Fine evening and night. Off the next day from work - usual day. It was like having Covid all over again (positive X2 in April - out of work for 5 weeks). Although the symptoms began about 12 hrs. following the injection and subsided about 24 hrs. later). My colleagues (work as a nurse in long term care - rehab) who had Covid in the past have experienced similar symptoms following the vaccine, even though we had Covid back in the spring. Dreading vaccine number 2 on Jan. 19th - hopefully I will be ok.
67 2021-01-03 chest discomfort about 1 hour and 15 minutes post injection (I waited in area as recommended for thirty minutes becau... Read more
about 1 hour and 15 minutes post injection (I waited in area as recommended for thirty minutes because of hx), I had the sudden onset of itchy runny nose and chest tightness and wheezing of significant intensity that I needed to use inhaler then and again later in the day. Noteworthy, I had as a precaution taken prednisone 20mg p.o about 2 hours before the injection. I had to take more later that afternoon because of symptoms. I then seem better but several times since the vaccine I have needed to uses the inhaler and take prednisone more than I have except after an infection about 6 years ago that precipitated similar symptoms to now. Today I had a flare significant enough that except for covid I might have gone to the ER or urgent care.
67 2021-01-03 loss of consciousness disoriented; hit her head and cut herself; hit her head and cut herself; Passed out at night; This i... Read more
disoriented; hit her head and cut herself; hit her head and cut herself; Passed out at night; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose at left arm for COVID-19 immunization. Medical history included Atrial fibrillation/heart problems diagnosed prior to the vaccine, got the COVID virus on 18Nov2020, disoriented in Nov2020. Concomitant medications included her heart medication every day and vitamins, nothing out of the normal. Caller stated she had heart problems. The heart problems were diagnosed prior to the vaccine. Caller also stated that she got the COVID virus this year before the vaccine as well and she was off, of work for like a month. On 23Dec2020 she got the vaccine. Then on Thursday 24Dec2020 and Friday 25Dec2020 she had a reaction. She had passed out in the night, hit her head and cut herself, she was then disoriented for 1 full day. Caller stated that the last time she was disoriented like this was when she had the COVID Virus, because she had heart problems. Caller stated that she was fine now. Caller stated that she had been off, of work so much. The heart problem she had was Atrial Fibrillation. Caller clarified that she had the COVID virus this year in Nov2020, it was before thanksgiving, on 18Nov2020 she had the virus, then on 19Nov2020 she got tested and it was positive. She got the vaccine on the 23Dec2020 Wednesday then on 24Dec2020 at night she passed out and on 25Dec2020 she was disoriented all day. Investigation Assessment: No. On 24Dec2020 she was going to bathroom, and found herself on the floor, then the following day 25Dec2020 was when she was disoriented. She knew this because when she had the actual COVID virus previous in Nov2020 this happened previously. When queried outcome of being disoriented she stated that she still felt a little weird but if getting better very, very slow. The Second dose was schedule for 13Jan2021. Caller confirmed that she did have a Positive Test for Covid Previously. Her treatment at the time was in the Emergency Room, they gave her an Antibody infusion, she had to schedule it because it was actually a clinical trial. Caller was asked if she knew the name of covid test, she stated that she does not know, she only recalled that she opened her mouth and they test her that way. The outcome of the event "disoriented" was recovering, of the other events was unknown.
67 2021-01-07 chest discomfort Following administration of the first dose of the COVID19 vaccine (Pfizer) patient reported right si... Read more
Following administration of the first dose of the COVID19 vaccine (Pfizer) patient reported right sided lip tingling (no swelling or drooping), and a "weird" feeling in chest (no additional details provided). Patient appeared anxious, but declined feeling anxiety. Patient declined medical treatment/follow-up and her symptoms resolved. Note: Patient received second dose of COVID19 vaccine (same lot# EH9899) on 1/8/2021 with close monitoring and no adverse reactions occurred.
67 2021-01-10 palpitations, chest pain 5 minutes after vaccination, patient reports heart pain, chest palpitations, shortness of breath, an... Read more
5 minutes after vaccination, patient reports heart pain, chest palpitations, shortness of breath, and shakes that patient attributes to anxiety from possible reaction.
67 2021-01-11 palpitations, heart rate decreased, lightheadedness symptoms began as patient was leaving post vaccination, patient began to have a vagal response with... Read more
symptoms began as patient was leaving post vaccination, patient began to have a vagal response with feeling like her heart was racing, HR 80. Patient was observed for 15 minutes. Patient states feels normal. As patient was leaving states she doesn't feel so good. Staff spoke with patient re: symptoms, Patient was observed for 30 minutes. HR was 60 at time patient left. Patient states she feels normal.
67 2021-01-12 heart rate irregular, heart rate increased I IMMEDIATELY FELT LIGHT HEADED WITH A FAST HEARTBEAT AND UNSTEADY. MY HEAD FELT VERY HEAVY AND MY B... Read more
I IMMEDIATELY FELT LIGHT HEADED WITH A FAST HEARTBEAT AND UNSTEADY. MY HEAD FELT VERY HEAVY AND MY BLOOD PRESSURE ( WHICH IS NORMALLY LOW WENT TO 160/86). AFTER ABOUT 45 MINUTES I FELT WELL ENOUGH TO DRIVE HOME. MY LAST BP READING WAS 150/75. AGAIN TODAY ( 1 DAY LATER ) AT MID-MORNING I GOT UP FROM DESK AND FELT LIGHT-HEADED AND JUST A BIT UNSTEADY. NOT SURE IF THIS IS AN ALLERGIC REACTION BUT ACCORDING TO PFIZER'S FACT SHEET "FAST HEARTBEAT AND DIZZINESS / WEAKNESS" ARE CONSIDERED SEVERE ALLERGIC REACTIONS!
67 2021-01-12 pallor, loss of consciousness The lady lost consciousness, not responsive, pale, dizzy, was evaluated on site by fire rescue. Tra... Read more
The lady lost consciousness, not responsive, pale, dizzy, was evaluated on site by fire rescue. Transferred to hospital by ambulance at 9:11 am and the lady and husband refused to go to the hospital. Released home at 9:27 am.
67 2021-01-20 cerebrovascular accident Patient received vaccine and 2 days later suffered a CVA
67 2021-01-24 loss of consciousness 1-21-2021 vaccinated #2 light headed dizzy - must has passed out during night getting upt o bathroom... Read more
1-21-2021 vaccinated #2 light headed dizzy - must has passed out during night getting upt o bathroom work up in am with bloody sheets and pillow - went ot ED for staples for laceration on head.
67 2021-01-24 fainting, heart rate increased The patient fainted about 15 minutes post-vaccination. Elevate Hr 115 BP 95/65 RR: 20 unlabored. To... Read more
The patient fainted about 15 minutes post-vaccination. Elevate Hr 115 BP 95/65 RR: 20 unlabored. Took 5-7 minute for symptoms to subside. Vital signs were taken again HR 90 BP 98/64 RR 18 and the stable patient stated that she felt fine and was going home. He spouse was driving her home.
67 2021-01-27 chest discomfort Within 15-minutes of vaccination, the patient reported pruritus on their neck and chest.
67 2021-01-27 palpitations Within 15-minutes of vaccination, the patient reported that their heart was racing. EMS monitored pa... Read more
Within 15-minutes of vaccination, the patient reported that their heart was racing. EMS monitored patient on-site. No record of hospital visit.
67 2021-01-27 loss of consciousness light headedness and loss of consciousness
67 2021-01-30 loss of consciousness Shot administered 6:08pm. About 6:18pm I felt very tired and wanted to close my eyes. I told my husb... Read more
Shot administered 6:08pm. About 6:18pm I felt very tired and wanted to close my eyes. I told my husband 'I don't feel well'. Immediately my eyes rolled back and convulsions started. Then I passed out. EMTs were called over to car and started to administer oxygen. I woke up about 6:30pm cognizant of surroundings. BP was normal. No fever, no rash, no chills. I was just tired. Then 2 hours of vomiting started. Last vomit about 8:15pm in ambulance. EMT unable to administer IV. After waiting in ER waiting room for 45+ minutes, a bed was available (around 9pm). ER doctor gave me ondansetron ODT 4mg Once. Released at 10:12pm to go home. Next 3 days symptoms of lightheadedness and dull headache.
67 2021-01-31 chest pain 30 minutes after receiving the vaccine i started to have left chest and jaw pain that worsened over... Read more
30 minutes after receiving the vaccine i started to have left chest and jaw pain that worsened over the next 10 minutes... i took 2 nitroglycerin 5 minutes apart and over the next hour it mostly resolved called the cardiologists office told to go to ER with further symptoms. Spoke to my cardiologist the next day she said she had someone with similar symptoms that went to the ER and workup was ok.
67 2021-01-31 chest pain Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux dise... Read more
Severe chest pain, pain in jaw, brow bones and headache (may have been due to GERD- acid reflux disease), symptoms started at 11:30PM while in bed and lasted 1-2 hours; sudden onset and dissipation
67 2021-01-31 chest pain Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion... Read more
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion-Severe, Systemic: Other- mild chest pain, dizziness, feeling like she was going to pass out or fall asleep-Medium
67 2021-01-31 chest discomfort day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipat... Read more
day 13, 14, 15 mild headache, feel like early onset of head cold: low energy, heavy chest; constipated with only small soft BM after product use; self care
67 2021-01-31 blood pressure increased itchy, tingly lips. Gave 50mg Benadryl IM. Monitored for 45 minutes. Had driver. Advised to F/u w... Read more
itchy, tingly lips. Gave 50mg Benadryl IM. Monitored for 45 minutes. Had driver. Advised to F/u with PCP about elevated BP.
67 2021-02-01 blood pressure increased Blood pressure shot up evening of the vaccination. Still high, getting treated by personal physician... Read more
Blood pressure shot up evening of the vaccination. Still high, getting treated by personal physician.
67 2021-02-01 chest discomfort, palpitations Itching at injection site within 3 minutes or less from time of injection, After two to three minute... Read more
Itching at injection site within 3 minutes or less from time of injection, After two to three minutes of the itching episode, heart racing followed by palpitations. Followed by chest tightness over heart area. Followed by shaking in upper torso and arms and hands. Became nauseous followed by weakness and a need of a wheel chair to get to my car. A few hours after arriving at home, itching started all over my body and nausea persisted through the night. Itching became stronger. The morning after the shot explosive diarrhea. Fatigue, chills and hot and cold feelings the following day as well as itching persisted. Now, two days later, itching remains with intermittent mild chest tightness which is abating and taking zytrec for the itching
67 2021-02-01 chest discomfort Patient reported to vaccine clinic to receive first dose of Pfizer Covid Vaccine. After receiving v... Read more
Patient reported to vaccine clinic to receive first dose of Pfizer Covid Vaccine. After receiving vaccine patient was sitting in observation area. Patient asked RN who was in observation area if it was normal to feel chest pressure after the vaccination. RN took patient to ER for full workup for chest pain. All labs within normal limits. Cardiology was consulted. Awaiting consult notes
67 2021-02-02 hypertension headache, weakness, body aches, high blood pressure
67 2021-02-03 heart rate increased PfizerpBioTech Covid19 Vaccine EuA awakened in night with fast heartbeat of 93-96
67 2021-02-04 blood pressure increased I was hospitalized with a severe reaction to my first dose of the Pfizer vaccine given 2/1/21 @ 9:45... Read more
I was hospitalized with a severe reaction to my first dose of the Pfizer vaccine given 2/1/21 @ 9:45. I was discharged Tuesday evening 2/2/21. Dr., my internist, agrees that what happened was not a vasovagal syncope (hospital?s diagnosis). My Experience: Within say 7 minutes of the injection I felt woozy, the wooziness intensified, I got intense pins and needles in my lower legs, fore arms and hands, and less so in my face. My speech became very slowed down, slurred and I had a lot of difficulty forming words. It was as if I was extremely drunk. After they called the paramedics, I was not able to get myself out of my car or walk. I lost motor coordination/control in hands and feet. I was cold, never felt faint, and had slightly evaluated blood pressure for me( normal is 110/64 paramedics got it at 152/94).
67 2021-02-04 chest discomfort chest tightness; This is a spontaneous report from a contactable physician reported for herself. A 6... Read more
chest tightness; This is a spontaneous report from a contactable physician reported for herself. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular on left deltoid on 17Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing asthma well controlled. There were no concomitant medications. The patient experienced chest tightness on 17Jan2021 with outcome of recovered on 17Jan2021. Event reported as serious with medically significant. It is reported that the patient wanted to report a side effect she had when she and her husband got their first Covid vaccine from Pfizer on 17Jan2021. She had chest tightness 15 minutes later. She asked for her husband's albuterol inhaler and was back within baseline within minutes. Stated that she used her husband's albuterol inhaler once and recovered completely. Clarified the name as Albuterol HFA 90mcg Inhaler (90mcg; one box has 200 puffs). Sender's Comments: A causal association between BNT162B2 and the reported event cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
67 2021-02-04 fainting found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breat... Read more
found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breathing; blank stare; This is spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an 28Jan2021 (at the age of 67-years-old) at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient was found collapsed and very confused, unresponsive, and experienced difficulty breathing on 29Jan2021. The events caused hospitalization and were reported as life-threatening. The patient also experienced blank stare on 29Jan2021. The clinical course was reported as follows: The patient had a blank stare after receiving the first dose of the vaccine. The patient was later found collapsed and very confused. She was taken to the hospital, became unresponsive, and had difficulty breathing. The patient required intubation and sedation and remained in hospital. Therapeutic measures were taken as a result of found collapsed and very confused, unresponsive, and difficulty breathing as aforementioned. The clinical outcome of found collapsed and very confused, unresponsive, difficulty breathing, and blank stare was unknown.
67 2021-02-05 palpitations, blood pressure increased Headache, light headedness, spike in blood pressure of 180/106, fatigue, racing heart rate
67 2021-02-06 chest discomfort Swollen glands in upper right neck, under jaw Tightness in chest; shortness of breath Malaise I fee... Read more
Swollen glands in upper right neck, under jaw Tightness in chest; shortness of breath Malaise I feel like I have the mumps
67 2021-02-07 blood glucose increased 15 minutes after client received vaccine client stated that she felt dizzy and weak. Vital signs ob... Read more
15 minutes after client received vaccine client stated that she felt dizzy and weak. Vital signs obtained by EMS BP 119/72, Pulse 72, Temp 99, O2 sat 96% Blood Sugar 107 at 1:43 pm. Client was wearing 2 face masks. She removed the mask and stated she feels better. States she was hungry. After EMS obtained 2 sets of vitals within normal limits, patient stated she felt better and was discharged home by EMS at 1:45 pm.
67 2021-02-07 heart rate increased Patient had an increase in heart rate and anxiety post administration of vaccine. EMS was called on ... Read more
Patient had an increase in heart rate and anxiety post administration of vaccine. EMS was called on site.
67 2021-02-07 chest discomfort Within 2 minutes of receiving the COVID19 vaccine I became moderately mentally foggy with mild dizzi... Read more
Within 2 minutes of receiving the COVID19 vaccine I became moderately mentally foggy with mild dizziness and headache. I then experienced tightness in the center of my chest and a generally mild shakiness. After waiting my 20 minute observation time, I recovered enough to drive home. However, mild mental fogginess, headache, tightness in chest and generally feeling unwell remain for 24 hours.
67 2021-02-07 chest pain, palpitations Within 5 mins, pt notified staff she felt she was having a reaction. Pt c/o shortness of breath, che... Read more
Within 5 mins, pt notified staff she felt she was having a reaction. Pt c/o shortness of breath, chest pain, bilat leg numbness, no hives present, denied difficulty swallowing. Pt was brought to a room, placed on 02 10L by face mask. Initial BP 200/105 HR 116. Pt became non-verbal, PA-C dx'd stridor, epi 0.3mg was given deep IM to right thigh. Pt responded positively, within 2 mins, pt became alert and was able to respond to questions. EMS was contacted, arrived and took pt to hospital. She was unable to ambulate c/o of all over body numbness, racing HR. Pt was admitted for observation at Medical Center.
67 2021-02-07 blood pressure increased, palpitations blood pressure went up considerably; Heart racing; suddenly felt very warm; This is a spontaneous re... Read more
blood pressure went up considerably; Heart racing; suddenly felt very warm; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 21Jan2021 at 14:45 (at the age of 67-years-old) as a single dose for Covid-19 immunization. Medical history included a history of asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination or additional vaccines on the same day. On 21Jan2021 around a half hour after administration (also reported as within 40 minutes) the patient started having symptoms of suddenly felt very warm, her blood pressure went up considerably and her heart was racing. The patient went to Urgent Care and Urgent Care advised to take her to the Emergency Room as they did not have an EpiPen. The patient was advised to go to the Emergency Room and was in transit to the ER. The clinical outcome of the events blood pressure increased and palpitations was not recovered; for feeling hot it was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
67 2021-02-08 loss of consciousness Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unw... Read more
Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation. Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3. Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills. Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-02-08 pallor Systemic: Other- Shortness of breath and pale color
67 2021-02-09 blood pressure decreased Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb a... Read more
Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb and go numb a bit; arm began to hurt then throb and go numb a bit; The patient was cold; clammy; the first blood pressure was 90 over something/second blood pressure was 70 over 40 something; diarrhea; tired; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 3247), via an unspecified route of administration in the left arm on 18Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 18Jan2021 10:10, the patient's arm began to hurt then throb and go numb a bit. On 18Jan2021 10:15, the patient started sweating. She stood up to try and feel better. The patient's husband called the nurse over and they called the paramedics because they said the patient was cold, clammy, and still sweating. The patient sat down again and they put leads on me to check her heart rate, blood pressure (BP), and oxygen on 18Jan2021. Her heart rate and oxygen were fine but the first BP was 90 over something. A few minutes later, she closed her eyes and could have fallen asleep right there. Her second BP was 70 over 40 something. She opened up her eyes and tried to stand up again. After a few more minutes, her BP came up and was OK. They refused an ambulance and went home. She had diarrhea at home on 18Jan2021. She ate, walked and felt better. She just experienced the normal tired and hurt arm in the afternoon on 18Jan2021. She rested the balance of the day. On Wednesday (20Jan2021), she got a bumpy itchy rash on both legs which is still present but with cream, it was OK. No treatment was received for the adverse events. Outcome of the "the first blood pressure was 90 over something/second blood pressure was 70 over 40 something" was recovered on 18Jan2021 and of the remaining events was recovered on Jan2021.
67 2021-02-11 chest discomfort On Christmas day I was working and then you started feeling like a pinching in my chest, like when y... Read more
On Christmas day I was working and then you started feeling like a pinching in my chest, like when you are going to catch a cold, that went on through the afternoon. In the afternoon I started with light headache and dry cough (intermittent), no temperature. I did not take anything for it and continued working. When I got home, I felt weak and was supposed to join my family for Christmas and decided not to go. And went to sleep. The next day (Sat) I was still not feeling well, weakness on my limbs, I went to the hospital to see if I could get checked and they told me to return on Monday because Occupational Health was closed on the weekends. I went home and treated myself with Tylenol and Vitamin C. On Monday I got tested and was positive. By then, I was coughing, limbs weak, had temperature (101F). I started to get weaker an weaker and Tuesday or Wednesday my work called me and asked me if I would like to come see a doctor. Wednesday I started with shortness of breath. I called my PCP and he prescribed me an albuterol inhaler. It helped me but my cough got worse by Saturday. My doctor then told me to go to the hospital (I live by myself). At my choice I went to Medical Center and were admitted and was hospitalized for 6 days. They kept treating me with inhaler and oxygen. They wanted to send me to rehab but I told them I wanted to go home. I came home with oxygen and with albuterol inhaler and the ambulance had to bring me home. I still was feeling very weak, had cough, and had the shortness of breath. And I have been home since then. I have home health and a therapist that come check on me 2X a weekly.
67 2021-02-11 blood pressure increased Patient experienced shortness of breath with ineffective breathing. A blood pressure reading was 22... Read more
Patient experienced shortness of breath with ineffective breathing. A blood pressure reading was 220/90, HR 95. RR over 20. There was no stridor or wheezing, but short, ineffective breaths. The patient did NOT lose consciousness.
67 2021-02-14 palpitations About 10 minutes after vaccine administered patient started experiencing a racing heart sensation. D... Read more
About 10 minutes after vaccine administered patient started experiencing a racing heart sensation. Described slight shortness of breath. Admitted to history of anxiety, has home xanax. Has not taken any today. Patients HR was at 110 initially after monitoring for about 15 minutes it stabilized to mid 70s. Patient has remained in the mid 70s for 20 minutes without any interventions. Complete resolution of symptoms.
67 2021-02-14 fainting I was felling a bit dizzy upon awakening the day after the vaccination. Once in the bathroom I becam... Read more
I was felling a bit dizzy upon awakening the day after the vaccination. Once in the bathroom I became very dizzy and started sweating profusely. I tried to walk back to the bedroom but fainted. I came to sitting on the floor. My husband brought me some water and stayed with me. It took quite a while for those symptoms to subside enough that I could get up and go back to bed. For the next 7 or 8 hours I felt chilly and somewhat tired. Normal by late afternoon and evening.
67 2021-02-14 palpitations heart palpitations; tongue swelling; This is a spontaneous report from a contactable consumer repor... Read more
heart palpitations; tongue swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL9262) vaccine , via an unspecified route of administration in the left arm on 27Jan2021 18:00 at single dose for covid-19 immunisation . Medical history included histamine issues, allergy to Naproxen, Sulfa, bee sting, eggs. The patient experienced heart palpitations and tongue swelling on 27Jan2021 19:30 with outcome of recovering. The patient took a Zyrtec before the vaccine and immediately after the vaccine she was fine. It was about 90 minutes after the vaccine while the patient was at home that she felt her tongue swelling and had heart palpitations. She took another Zyrtec and the palpitations and tongue swelling went down. Further information has been requested
67 2021-02-15 heart rate increased High heart rate, hard to breath, shivers, sore at injection site and general weak feeling
67 2021-02-15 loss of consciousness Patient reported numbness of the left vaccinated arm, "passed out" for a few seconds and became diap... Read more
Patient reported numbness of the left vaccinated arm, "passed out" for a few seconds and became diaphoretic. Cold packs applied. (BG = 126, BP180/100, T 97.2, HR 60, R 18, 18:16 time O2 was 94% room air, EKG Normal Sinus Rhythm Alert and Oriented. Repeat BP 98/78. Patient taken to ER or Clinic for further observation unknown if was a ER or clinic
67 2021-02-15 chest discomfort, heart rate increased in less than 5 minutes following vaccine administration patient was reporting a feeling of something... Read more
in less than 5 minutes following vaccine administration patient was reporting a feeling of something bad happening. She reported that her heart was going quickly and she was breathing fast. She then reported "funny feeling in my tongue." She was taken to an exam room immediately. She denied feeling of difficulty swallowing, tongue swelling, or trouble breathing. Vital signs pulse 120, blood pressure 190/90 while laying on exam table. Lungs clear without wheezing and pulse rapid but regular without murmur. Due to symptoms she was administered a dose of 0.3 mg of epinephrine via epi-pen in lateral left thigh. Patient not reporting difficulty swallowing and subsequently administered 10 mg cetirizine. Following epinephrine.
67 2021-02-16 skin turning blue Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyano... Read more
Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyanosis. EMS gave a breathing tx, O2 sats WNL. Declined transfer to hospital at that time for fear of Covid. Client exhibited confusion, oriented x 0, short term memory loss. Bronchial spasms resumed, EMS again called, transported via EMS to MC. Diagnosed with transient global amenesia and hypercapnia. Client was transported to MC for CT and MRI for r/o stroke. Stroke was ruled out. Client with c/o severe H/A, nausea, dizziness, myoclonic seizures. Severe h/a which lasted 4 days. Still experiences mild memory loss, confusion, and h/a are becoming less severe. Client states that sensory processing is slowed
67 2021-02-16 hypertension Within 15-minutes of vaccination, the patient reported nausea, pruritus on bilateral feet, her throa... Read more
Within 15-minutes of vaccination, the patient reported nausea, pruritus on bilateral feet, her throat "feeling itchy and weird", and that it was hard to swallow. EMS evaluated patient on-site and was found to be hypertensive (182/133). Administered 4mg Ondansetron PO and 50mg Benadryl IV. Patient was transported to ED for evaluation. In the ED, patient was hypertensive (191/85) but noted feeling better after Benadryl IV. No evidence of worsening allergic reaction or respiratory distress. Patient was discharged from ED with instructions to follow-up with PCP.
67 2021-02-16 fainting, heart rate decreased, blood pressure decreased syncope within 10 min. of injection, episode; BP 70/40 P 40-30 admitted to ICU; BP 70/40 P 40-30 adm... Read more
syncope within 10 min. of injection, episode; BP 70/40 P 40-30 admitted to ICU; BP 70/40 P 40-30 admitted to ICU; Adrenal Crisis; patient with a medical history CVID (Immunodeficiency common variable) received bnt162b2; patient with a medical history CVID (Immunodeficiency common variable) received bnt162b2; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration in Left arm on 19Jan2021 at single dose for COVID-19 immunization in hospital; antilymphocyte immunoglobulins (reported as immunoglobulin infusion, concentrate for solution for infusion, lot/batch number and expiration date not provided) via an unspecified route of administration from an unspecified date at unknown dosage for an unspecified indication. Medical history included CVID (Immunodeficiency common variable), Addison Dx (diagnosis) and Pituitary Tumor. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergies. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had syncope within 10 minutes of injection on 19Jan2021, episode, BP (blood pressure) 70/40, P (pulse) 40-30, admitted to ICU in Jan2021, determined adverse event maybe 2nd to immunoglobulin infusion received previous day leading to Adrenal Crisis, 2nd to Addison dx / Pituitary tumor which was unknown at time of vaccination. Events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient had been hospitalized for 6 days in Jan2021. Since the vaccination, patient had not been tested for COVID-19. The action taken in response to the events for antilymphocyte immunoglobulins was unknown. Therapeutic measures were taken as result of the events syncope, BP 70/40, P 40-30 and Adrenal Crisis. The outcome of the events "syncope, BP 70/40, P 40-30, Adrenal Crisis" was recovered in 2021. Patient then received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021. Pfizer is a marketing authorization holder of antilymphocyte immunoglobulins in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of antilymphocyte immunoglobulins has submitted the same report to the regulatory authorities. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT152B2 and antilymphocyte immunoglobulins to the events syncope, low BP and heart rate, adrenal crisis, cannot be excluded. The underlying Addison disease and Pituitary Tumor are major cofounders for the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-02-17 blood pressure increased my blood pressure went up uncomfortably. 178/82; This is a spontaneous report from a contactable con... Read more
my blood pressure went up uncomfortably. 178/82; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9263; expiration date: unknown), via an unspecified route of administration left arm on 26Jan2021 11:00 at a single dose for covid-19 immunisation. Medical history included hypertension and high cholesterol. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), acetylsalicylic acid (BABY ASPIRIN), bumetanide and rosuvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the day of the vaccination around 5 pm (26Jan2021 05:30 PM), the patient reported that her blood pressure went up uncomfortably to 178/82 [unit unspecified]. The patient did not received treatment for the adverse event. The event was considered as non-serious, but the event resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.
67 2021-02-18 hypertension She was sitting and got a slight HA, light headed a little bit also per report. She stated she knew ... Read more
She was sitting and got a slight HA, light headed a little bit also per report. She stated she knew her b/p was high because this is how she always feels every time hr b/p is high. she states she struggle with high and low b/p so she didn't take any of her meds today. Pt took a prn clonidine that was in her purse for b/p 200/100 hr-120 @ 1415. 1445 b/p 180/98, hr-99 pt report HA and dizziness is resolved. Pt instructed to stand up and see how she feels. States she feels fine and is ready to go home. Pt escorted to car with her daughter. Instructed to follow up with MD as needed.
67 2021-02-21 increased heart rate 5:20PM 'SOB, DIZZY, THROAT TIGHT'. PLACED ON COT WITH HEAD ELEVATED. CONTINUES TO HAVE SOB. 5:30PM ... Read more
5:20PM 'SOB, DIZZY, THROAT TIGHT'. PLACED ON COT WITH HEAD ELEVATED. CONTINUES TO HAVE SOB. 5:30PM STATES 'FEELING BETTER'. 5:40PM BECOMING SOB AGAIN. 5:55PM INCREASED SOB/DYSPNEA- SQUAD CALLED. IV ATTEMPT X3 WITHOUT SUCCESS. 6:30PM TRANSPORTED TO ER VIA SQUAD, A/O X3, PINK, W/D, SEVERE DYSPNEA. (2-19-21 3PM TC PT RELEASED FROM HOSPITAL THIS AM. FULL RECOVERY .)
67 2021-02-21 body temperature decreased Full body aches Insomnia Headache Difficulty concentrating Temp low
67 2021-02-21 palpitations dizziness. Patient felt normal after drinking water. Sx resilved monitored for about 15-20 minutes ... Read more
dizziness. Patient felt normal after drinking water. Sx resilved monitored for about 15-20 minutes after symptoms resolved. PSOB, palpitations, chills, ED Precautions discuseed. BP 160/90 Hx High Blood Pressure T98.0 New BP 151/81 HR 78 #21 allowed to go home advised to contact pcp if symptoms recur or
67 2021-02-23 chest pain 2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like fee... Read more
2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like feeling, "heavy head", lethargic 2/9-2/10: Pretty much back to normal with the addition of an injection site "hot spot"- raised, rashy and feverish 2/11: Began feeling general malaise in the afternoon. Low grade fever, pain behind collarbone on both sides. By 7pm, severe chills. 2/12: Called PCP and advised of symptoms. Went and got a Covid19 PCR test just in case. Negative 2/13-2/15: Still had low-grade fever (usually around 100*) which often didn't present until 2pm and then stayed until bedtime. Glands became swollen, bad night sweats. Pain behind collarbone worse when sneezing, coughing, yawning, burping, etc. Additional information for Item 18: Almost like a "catch" rather than constant pain. 2/16: Went to local medical center for drive-thru rapid Covid 19 and flu test. Both came back negative as did the PCR Covid test they also ran. 2/17-2/20: Symptoms pretty much the same....no fever in the am and thought I was finally getting better, then it would spike again around 1:00-2:00. Never over 101*. On the morning of 2/21, the "catch" around the collarbone had moved down to the bottom of my ribcage. 2/22: Contacted PCP again and made appointment for bloodwork, chest x-ray, and further tests. "Sick and tired of feeling sick and tired!"
67 2021-02-23 chest discomfort Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness. P... Read more
Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness. Patient monitored for 30 minutes by EMS, VSS, lung sounds clear, SPO2 100%. Patient remained on-site for an additional 15 minutes then went home.
67 2021-02-23 heart rate increased Patient complains of increase heart ate (on her watch) and feeling very anxious. BP 155/75. HR 98
67 2021-02-23 heart flutter Pt. from tent 16 in observation lane complained of fluttery chest, difficulty swallowing, headache, ... Read more
Pt. from tent 16 in observation lane complained of fluttery chest, difficulty swallowing, headache, dry mouth. Paramedics assessed pt. once symptoms subsided paramedic released pt. to leave.
67 2021-02-24 chest discomfort vomiting, chest tigthness and shortness of breath, tongue swelling and difficulty swallowing
67 2021-02-25 fainting ALOC, passed out 30 minutes after vaccine - syncope. BP 146/77 (pulse 59), O2 sat 98%.
67 2021-02-25 chest discomfort Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patien... Read more
Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine 2nd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand All Collapse All 2/24/2021 Patient Date: 2/24/2021 Subjective is a 67 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, drooling, hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes none. She does not take any medications but is on Vyvanse.none. She denies any medial hx. Not on any medications. She did drink a protein shake this am. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, chest tightness and itching of skin (to R shoulder/injection site area) Patient denies fever, malaise/fatigue, nasal sores, sneezing, sore throat, frequent throat clearing, cough, shortness of breath, wheezing, rash, hives, eczema, abdominal pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 1024 02/24/21 1029 BP: (!) 180/73 (!) 150/90 Pulse: 71 SpO2: 97% Blood Sugar 108 collected at 1050 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Findings: No rash. Comments: Injection site and R arm without erythema or swelling. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) PT monitored and improving. Pt ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Pt aware of what to monitor and when to go to ED. Pt voiced understanding and appreciated. Pt able to ambulate out of the facility with ease. APRN Electronically Signed 2/24/2021 12:27 PM
67 2021-02-26 chest discomfort Chest pressure and anxiety- monitored and cleared by EMS
67 2021-02-26 chest discomfort Within 5 minutes of administration pt began to experience difficulty breathing and vigorously shake,... Read more
Within 5 minutes of administration pt began to experience difficulty breathing and vigorously shake, transported to gurney and obtained vitals, pt with O2 Sat 70%, HR 88, administered one dose of epinephrine, placed 10L of O2 via facemask, pt began speaking, was alert and oriented to name and place, continued to report tightness of the chest and itching, called EMS, continued to monitor vitals, and patient transferred to ER without incident.
67 2021-02-28 chest discomfort About six hours after the injection I experienced discomfort in my throat, mild swelling in both han... Read more
About six hours after the injection I experienced discomfort in my throat, mild swelling in both hands and face, some tingling in face, and head ache.I took Zyrtec 10 mg, Pepcid AC 20mg. Then I started to have tightness in my chest and used my albuterol inhaler. I was still having symptoms an hour later so took Benadryl 25 mg. During the night I woke up with mild wheezing and used my inhaler again. Throughout the next 2 days, I continued to have these symptoms (except for wheezing) off and on. Today, I still have some symptoms but not as often or severe.
67 2021-02-28 heart rate increased Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid... Read more
Loose bowels 2nd day after shot; Rapid heart beat for about an hour second day, but could be thyroid as well; Rapid heart beat for about an hour second day, but could be thyroid as well; Sore arm, not severe; Lethargic for a day; This is a spontaneous report from a contactable other health professional, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 26Jan2021 at 09:00 AM in the left arm (at the age of 67 years-old) for COVID-19 vaccination. Medical history included hypothyroidism, autoimmune disease, allergies to penicillin and many foods. Concomitant medications included etanercept (ENBREL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan potassium (LOSARTIN). The patient receive did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 09:00 AM, the patient experienced sore arm, not severe and was lethargic for a day. On 27Jan2021, the patient had loose bowels the second day after the shot and rapid heart beat for about an hour second day, but could be thyroid as well. No treatment was received for events, sore arm, lethargic, loose bowels, rapid heart beat and thyroid. The events were reported as non-serious. The clinical outcome of sore arm, lethargic, loose bowels, rapid heart beat and thyroid was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
67 2021-02-28 palpitations Patient reported that she was dizzy, SOB, blurred vision, rapid heart beat.
67 2021-02-28 chest discomfort, blood pressure decreased Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient felt faint, blood pressure dropped and 911 was called. pt's spouse informed us after the vaccination that she has this reaction with all vaccinations due to a branch block. paramedics cleared patient to leave after observation period.
67 2021-02-28 heart rate increased, chest discomfort not thinking straight; very very intense headache; felt an ungodly pressure in my head; My vision wa... Read more
not thinking straight; very very intense headache; felt an ungodly pressure in my head; My vision was off; foggy; confused; coughing; felt severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped; severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher you know more towards my throat; rapid heart rate, 100bpm and 102bpm and lasted for couple of days.; my head was more clear but still had some pressure and woozy; Trouble concentrating; ALT High; Test: Cholesterol; Result: Little High/Cholesterol 207 was high; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9269), via an unspecified route of administration on 07Feb2021 (at the age of 67-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Medical history included ongoing asthma, type 2 diabetes mellitus, seasonal allergy (told to take Zyrtec for seasonal allergies prophylactically). Facility in which the vaccine was received was a clinic at a high school through the local hospital. Concomitant medication included fluticasone propionate, salmeterol (WIXELA INHUB), glipizide (GLIPIZIDE). On 07Feb2021, the patient received the first dose and while walking to the observation area (about two minute after receiving the vaccine) the patient experienced very very intense headache, felt an ungodly pressure in my head, vision was off, and trouble concentrating. When she sat down got real foggy, confused and was not thinking straight, was coughing and experienced severe tightness in left side of my chest and that moved to the center of my chest and started to like move up higher, more towards my throat and then it stopped. Patient began taking deep breath. It went back over to left side of my chest and the tightness (stayed in my left chest for probably 3 days but not to the same degree). The fogginess and the intense pressure in my head, it was bad to the point she thought she would not be able to drive home, waiting for 30 minutes, and because she was not thinking clearly she didn't even ask anybody for help. When she got to the car she waited 15 minutes more before driving home. Patient stayed like this for 2 days. When she reached home, she experienced a rapid heart rate, 100bpm and 102bpm and lasted for couple of days. Each day got gradually better, her head was clearer but still had some pressure and woozy. The patient did visit the physician, he did an EKG and other test. The doctor did not think what I had was an anaphylaxis reaction. Physician recommended she make sure to take her inhalers, for asthma and told me to take Zyrtec (for seasonal allergies) ahead of time. Consumer inquired if she should receive the second dose. The patient underwent lab tests and procedures which included blood cholesterol: little high 207 on Feb2021, blood thyroid stimulating hormone: normal on Feb2021, electrocardiogram: normal on Feb2021, full blood count: normal on Feb2021, hemoglobin: 6.9 on Feb2021, heart rate: 100 bpm on Feb2021, heart rate: 102 bpm on Feb2021, metabolic function test: Alt high on Feb2021. No treatment was given for the events. The clinical outcome of the events not thinking straight, pressure in my head, foggy, confused, coughing, tightness in the left side of my chest , it then moved to the center of my chest then moved up towards throat, rapid heart rate, Woozy, intense headache, vision was off and trouble concentrating was recovering while ALT High, and Cholesterol; Result: Little High was unknown.
67 2021-03-02 palpitations Fever to 102, chills, body aches. Palpitations headache, nausea everything started the day after sym... Read more
Fever to 102, chills, body aches. Palpitations headache, nausea everything started the day after symptoms lasted until 3/2/2021
67 2021-03-02 palpitations Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I cou... Read more
Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I could not sleep; Extreme fatigue; Slight headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (brand=PFIZER), via an unspecified route of administration (vaccine location=right arm) on 28Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included breast cancer and mitral valve prolapse. She had no known allergies. Concomitant medications included celecoxib (CELEBREX). No other vaccine in four weeks. No covid prior vaccination. The patient experienced heart palpitations on 28Jan2021 10:00 PM to the point where she could not sleep - started 6-8 hours after receiving vaccine. Some better the next day but still having palpitations. Day 2 after vaccine about the same. Extreme fatigue, slight headache & sore arm but not too bad on an unspecified date in 2021. No treatment received for the events. No covid test post vaccination. The patient was recovering from heart palpitations to the point where I could not sleep while outcome of other events was unknown. Information on the lot/batch number has been requested.
67 2021-03-02 blood pressure increased blood pressure went up/blood pressure was 156/81/her blood pressure was 180 over 80 something; This ... Read more
blood pressure went up/blood pressure was 156/81/her blood pressure was 180 over 80 something; This is a spontaneous report from a contactable consumer who reported for herself, a 67-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263), intramuscular in left arm, on 26Jan2021 at 11:00, at the age of 67 years, at a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol, ongoing high blood pressure, and eyeglasses wearer. Ongoing concomitant medications included nebivolol hydrochloride (BYSTOLIC Tablet) for high blood pressure, bumetanide tablet taken as diuretic, rosuvastatin calcium (ROSUVASTIN Tablet) for high cholesterol, and acetylsalicylic acid (BABY ASPIRIN Tablet) to keep healthy. The patient reported that her blood pressure went up and is still up since last Tuesday (as reported). She received the first dose of the COVID vaccine at 11 am. She was okay until that evening around 5 pm, her blood pressure started going up, her blood pressure shot up. She called her doctor. Her doctor and her did not know if her blood pressure going up could be from the vaccine. Her doctor told her to take more of her already prescribed blood pressure medication. The next day, she went to see her doctor due to blood pressure still being high and he gave her more blood pressure medications. Her doctor prescribed a different kind of blood pressure medication to take along with her existing blood pressure medication (BYSTOLIC). She is concerned and asked if her elevated blood pressure will go back to normal, her blood pressure is still high. Her doctor told her when someone has a reaction to a vaccine, it usually takes days or up to two weeks to recover from the reaction. Her blood pressure is still high and her doctor is puzzled and prescribed her more medications to control her blood pressure. Today, 01Feb2021, at the doctors office her blood pressure was 156/81. Yesterday, 31Jan2021, her blood pressure was 180 over 80 something. She puts her glasses on to read the card. Patient would like to know how long will her symptoms last and if she is going to die from this. She is getting nervous and requests to be transferred to address her question. She thought she was the first person this has happened to but she read online that one person has had the same symptoms with high blood pressure after receiving the vaccine. She had been advising everyone to get the vaccine but now she will advise her family to hold off. The outcome of the event was not recovered.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263) to reported event Blood pressure increased cannot totally be excluded.
67 2021-03-03 palpitations 3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded... Read more
3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded range between 59 and 166. 3/4 - itchy rash near injection site ( have photo)
67 2021-03-03 blood pressure increased Could have died with a blood pressure with these numbers; Blood pressure had spiked up to 235/104; T... Read more
Could have died with a blood pressure with these numbers; Blood pressure had spiked up to 235/104; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN9581), via an unspecified route of administration in the left arm on 09Feb2021 at 13:00 at 67-years-old at a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any prior vaccinations within 4 weeks of the Pfizer suspect vaccine. Medical history included blood pressure increased (BP raised) in Sep2020 (BP reading was 135/80). There were no concomitant medications. The patient experienced: "could have died with a blood pressure with these numbers" (medically significant, life threatening) on an unspecified date, and blood pressure had spiked up to 235/104 (medically significant, life threatening) on 11Feb2021 at 16:30. The clinical course was reported as follows: The patient reported that she was a healthy person; and she had never had blood pressure problems before (as reported). The patient also reported that she was "on no medications whatsoever." Five months ago (from the time of the report), the patient had a wellness exam. The patient's "blood pressure was perfect." It was reported that "everything was perfect" with her health exam five months ago. Five months prior, the patient's BP reading was 135/80. The patient thought that the COVID vaccine was very dangerous and she was unaware that hypertension could even be a side effect. The patient received the vaccine on 09Feb2021, and she "got a long fine while waiting at the facility." Two days later, on 11Feb2021, the patient took her blood pressure and she could not believe the reading. The patient then went to a pharmacy and had the pharmacist take it for her because she thought "she was crazy"; and because she thought her machine was not right. The patient's blood pressure had spiked up to 235/104. When the pharmacist took her blood pressure, they told her she needed to go to the ER immediately. The patient was informed her blood pressure was beyond stroke level; therefore, she was rushed to the ER and was given IV BP medications to try and get her blood pressure down. The patient was released to home. The patient, after she went to the ER the first time, she was told to go see her primary care the following day. Two days later she was back in the ER with spiked blood pressure on 13Feb2021. The patient's blood pressure on 13Feb2021 was 224/84. The patient was again treated and released. The patient stated that she saw who she believed was a physician assistant (PA). The patient was started on a blood pressure medication as well; and her last and most recent blood pressure reading was 144/85. The patient reported that the she was prescribed hydrochlorothiazide. After the patient's first ER visit, she was prescribed 12.5mg once a day. However, after the second ER visit, she had a blood pressure spike and the dose was increased to 25mg once a day. The patient received the paper with side effects, and she had none of the side effects listed; "none, whatsoever." The patient read that the more severe side effects were difficulty breathing, fast heartbeat, rash, dizziness. The patient further stated that "under that, it was list serious and unexpected side effects may occur"; this was where the patient felt like her situation come in. It was serious and unexpected. The patient reported that she was upset; and felt that she could have died with a blood pressure of those numbers. The patient reported that she was a healthy person and she was looking forward to getting the vaccine. The patient stated she would not be getting the second vaccine. The patient wished she just had the normal listed side effects such as arm soreness, joint pain, fever, headache; however, she did not experience any of those events. The patient felt that if she did not check her blood pressure at home on her own, she would not have known her blood pressure was that high. The patient then added she had spoken to a couple of doctors and they had a total of five cases that were very similar to hers and had to be treated. The patient underwent lab tests and procedures which included blood pressure: spike on an unspecified date, blood pressure: 135/80 in Sep2020, blood pressure: 235/104 on 11Feb2021, blood pressure: 224/84 on 13Feb2021, blood pressure: 144/85 in Feb2021, health exam: everything was perfect on an unspecified date. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown. Adverse events following prior vaccinations: None. The patient did not remember getting any other vaccinations.
67 2021-03-03 chest discomfort Patient received Covid-19 vaccine dose #1. Patient developed tongue tingling approximately 45 min af... Read more
Patient received Covid-19 vaccine dose #1. Patient developed tongue tingling approximately 45 min after vaccine. Zyrtec 10 mg po given. patient then reported chest tightness and SOB, epi 0.3mg given and 911 called. Patient transported to ER via ambulance in stable condition.
67 2021-03-05 fainting, hypertension After 30 minute observation after vaccination per protocol for anaphylaxis history, patient left uni... Read more
After 30 minute observation after vaccination per protocol for anaphylaxis history, patient left unit at 5:55pm and as she was leaving facility she reported symptoms to staff of "high blood pressure", "faintness", dizziness, lightheaded, weakness per patient--patient was assessed by EMS on site and BG was 86, BP elevated at 161/76. After further observation but no significant progression or improvement of symptoms she agreed to be transported to ED at 6:30pm.. No medications given on site, juice and crackers provided for low BG and report of missing meal,
67 2021-03-07 palpitations About ten minutes after the shot, my heart suddenly started pounding, I was panting, and I got very ... Read more
About ten minutes after the shot, my heart suddenly started pounding, I was panting, and I got very hot. Then tingling went all over my body, even in my lips. At one point, I felt close to fainting. The pharmacist lady gave me cold water (I asked for it), and I just sat there for quite a while. Gradually my heart rate came down, and I got cold, but the tingling kept going, and I felt somewhat weak. Since I didn't want any epinephrine (it affects my heart), and I didn't think I was so bad that I needed an ambulance, after being there nearly an hour my husband drove me home. There I took some liquid Benadryl, and that seemed to help with the tingling. I just took it easy after that. Considering my reaction tothe first dose, I will NOT be getting the second one. I don't need to consult with a doctor to decide that. It was somewhat frightening because I didn't know how bad it was going to get.
67 2021-03-07 chest discomfort Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/... Read more
Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/labored breathing; tightness in the chest/chest felt tight there was a heaviness just like a feeling of discomfort; joint pain started in her right elbow, right thumb, right knee, left ankle and left instep; Feeling unwell; Muscle pain; Injection site pain; Headache; has not felt normal; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), intramuscularly on 22Jan2021 09:35 at 0.3 ml single dose for COVID-19 immunization. Medical history included ongoing High cholesterol, allergies to penicillin and sulfanized antibiotics, allergies to latex, Shingles since 2007, post herpetic neuralgia, mild shingles pain from the neuralgia, changes in temperature, the temperature and the weather going up and down. No other condition was reported. Concomitant medication included rosuvastatin (strength: 10mg) from 18Jan2021 to 24Jan2021 at 10 mg for High cholesterol. Past drug event included doxycycline allergy (she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP and unable to sleep), Ibuprofen allergy, Levaquin allergy, Valium allergy and omeprazole allergy, took sulfanized (SULFA) antibiotics allergy (she had rapid heartbeat, sweating). Patient stated she said that she had received the first dose of the COVID-19 vaccine and did experience some side effects of the COVID-19 vaccine. She said she did not have an anaphylactic reaction but had difficulty in breathing 2 days after having the first dose. She said she experienced 30 hours of labored breathing. She wanted to know if there is "sulfa dioxide" in the lipid/mRNA portion of the COVID-19 vaccine. She said she is highly allergic to "sulfanized compounds". She is also allergic to all forms of penicillins. Caller wanted to know if the second dose of the vaccine has the same ingredients as the first dose. She wanted to know if the ingredients have the same amounts as the first dose or if the actives are stronger. She based this question from "most people having more reaction on the second dose of the vaccine" and also from what Pfizer second line told her "the first dose primes the system while the second dose strengthens the system". She wanted to know what ingredient causes the anaphylactic reactions for this vaccine and if it is penicillin. On 22Jan2021 she learned that there is a small amount of Sulfa Dioxide in the lipid portion of mRNA and she is highly allergic to sulfa compounds. With her side effects she would also like to add that she had a severe case of shingles in 2007 that was not diagnosed until the end of the 7th week. She had seen 8 doctors, her family doctor, she had 3 ER visits so prior to the vaccine she had post herpetic neuralgia and so a week and half before the vaccine there were changes in temperature, the temperature and the weather going up and down so she was having mild shingles pain from the neuralgia going into the vaccine which was given on 22Jan2021. The other thing is she had high cholesterol and her cardiologist put her on a statin she does not have high BP but she has high cholesterol so she was started on a statin, it was Crestor 10 mg, actually it says it is Rosuvastatin Calcium 10 mg and she took that 18Jan2021 and the 19Jan2021 and then on the 20Jan2021 her doctor told her to stop it before her vaccine so she did and she felt okay just had mild reactions so she took the Rosuvastatin that Friday night 22Jan2021 and she took it 23Jan2021 then she took her self-off of it on 24Jan2021. She called her doctor on 25Jan2021 and he said yes stop the Rosuvastatin and stay off it until after your second dose of the vaccine. So she was having an allergic reaction in Jan2021 she has had a lot of side effects from being post shingles and all the side effects from COVID vaccine and being post shingles and the statin all of the possible side effects mirror one another. As far as the reaction she got a headache about 35 minutes after she took the shot Friday morning at about 9:35 AM and she took Tylenol twice that day, once that morning and she took it also around 4:30 PM when she was having medium pain at the injection site and that is when she took her statin and she woke up on 23Jan2021 and until late in the afternoon she had tightness in the chest so she took one more Tylenol then that was mid-morning, so total she had 3 doses of 325 mg Tylenol. Then on 24Jan2021 at about 4:30 AM in the morning she woke up with labored breathing, it wasn't normal. She did not have a closed throat but her breathing was labored, her chest felt tight there was a heaviness just like a feeling of discomfort. Then around 5 pm that same day the joint pain started in her right elbow, right thumb, right knee, left ankle and left instep and the pain wasn't constant it was jumping to different parts of her body and she still felt the tightness in her chest and heaviness all day. Then around 4PM on 24Jan2021, Saturday the labored breathing dissipated around 8pm and she did not take the statin that night then on 25Jan2021 her breathing was normal but she still had tightness in her chest. She had injection site pain on the 22Jan2021, 23Jan2021 and the 24Jan2021 and it was almost totally gone on 25Jan2021. Tiredness began on the evening 22Jan2021 the day she had the shot and it comes and goes. Headache- she had mild headache and she had took Tylenol so it was mitigated a little but it started 22Jan2021 and she had a headache through the 23Jan2021, 24Jan2021 and the 27Jan2021 so around 3:25PM yesterday she took another Tylenol yesterday 27Jan2021. Muscle pain she has had since 23Jan2021 and it has been ongoing but less today, she doesn't know if it will come back or not. It is mainly in the in the rhomboids which is the shoulder wings. She had it on both sides. Chills she had 25Jan2021, 26Jan2021 and 27Jan2021 and they come on mid-day-late afternoon they go on up until early evening, a little past supper/dinner time. Joint pain was 23Jan2021, 24Jan2021, 27Jan2021 and pain in her rhomboid muscles. She has had no fever, no swelling or redness at the injection site, no nausea. Feeling unwell- she would say from 23Jan2021 to the present she has not felt normal on 22Jan2021, it comes and goes She has not had swollen lymph nodes. Difficulty breathing 24Jan2021 at 4:30 am it woke her up and she had labored breathing, no closed throat and she stopped the Statin that day, tightness in her chest started 24Jan2021 in the morning and she had that 25Jan2021 26Jan2021 and it has been present on and off mainly in her back discomfort. She says the tightness is not really in the front around the heart but it is like a total tightness in the chest area. Muscle pain on the 27Jan2021 mainly in her back, the rhomboids. Fast heartbeat- She was sound sleep this morning at about 12:45AM and it woke her up her heartrate was 87, her BP was 135/81 (2021) and she did an ice pack for 16 minutes on her head and then she went back to sleep at 4:45 AM she woke up again her BP 131/87 pulse was 80 temp was 97.8 (2021). She didn't take her temp the first time she woke up she just did an ice pack for 16 minutes and she as up for a while typing side effects at that point. Then she went back to sleep from 6:20-7:20 and then when she woke up again her BP was 122/75 and pulse was 64, temp 98.3 (2021). For someone look at at her BP they may say that's not high but for someone post shingles, the pain, the nerve endings are already on edge she can feel it working on her body. They say reactions are proof that the vaccine is working but her issue with the joint pain, it disappeared when she stopped the Statin and then there is the labored breathing, she has had 2 new drugs that went into her system at the same time and she doesn't know, one has the documented side effects and the other one it is so unknown at least the mRNA part she does not know if she is just having a reaction to Sulfa. She says that blood pressure doesn't seem high but for someone whose body is stressed and with her pulse to go up when she is sound asleep, normally when her body is sleeping and she wakes up she would be about 117/70 (2021), she would have low numbers she doesn't have high BP. She took the statin for 2-3 days and then stopped it her doctor told her she could start and stop it and her doctor told her to stay off of it but she started it because she felt okay she only had a headache and injection pain so she said she is going to take it and then things intensified so she decided to stay off it. She has a history of having delayed serious side effects. She is allergic also to Penicillin and that is probably in the records already because she called and asked when she was thinking about taking it. It dates way back with her allergies with her, it is extensive Doxycycline, Ibuprofen, Levaquin, all forms of Penicillin, sulfanized antibiotics, Valium, latex, Omeprazole. She had shingles so bad after about 7.5 weeks of it going undiagnosed she had the 2 worse reaction and they asked her they went through her history and asked what are the 2 worst things she had and that was with Doxycycline they gave her that because they thought she had a bacterial infection and didn't realize it was shingles and she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP she was unable to sleep literally she could feel the blood coursing through her veins. and then the other one she knows is Sulfa she has had that allergy since a child but she had rapid heart beat, sweating and there may have been other symptoms but she does not remember she was a child. She has been given Sulfa drugs since then and she is highly sensitive to Sulfa. Outcome of the event muscle pain was not recovered; injection site pain was recovered on 25Jan2021; labored breathing was recovered on 24Jan2021, while other events was unknown. No follow-up attempts are possible. No further information is expected.
67 2021-03-08 palpitations During monitoring period post Pfizer COVID-19 vaccine, pt experienced throat constriction, ringing e... Read more
During monitoring period post Pfizer COVID-19 vaccine, pt experienced throat constriction, ringing ears, palpations, dizziness & lightheadedness. Vital signs: 194/91-80-98% reporting throat constriction, & palpitations. Given benadryl 25mg IM x 1. Continued to monitor patient expressed throat "is closing but just a little bit" with lightheadedness & dizziness. Epinephrine 0.3mg IM given x 1. Pt reporting more dizziness and lightheadedness and that she is diabetic, coke given, pt does not have her glucometer on hand. EMS called for evaluation. EMS decides not to transport pt after pt states that she does not want to be transported. Patient monitored for 15-20 more minutes and went home with husband.
67 2021-03-08 chest discomfort First 48 hours reports felt fine. Sunday am felt achy and tired. Took advil and aspirin. Reports the... Read more
First 48 hours reports felt fine. Sunday am felt achy and tired. Took advil and aspirin. Reports the next 8 days she felt sleepy and achy. Reports felt ok couple of days. Friday 3/5/2021 she had a fever, loss of appetite, chills, for 24 hours. Sunday night had trouble breathing SOB. used humidifier. Chest felt tight. minor cough, symptoms similar to asthma.
67 2021-03-08 heart rate increased, blood glucose increased Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cra... Read more
Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cramps. Difficulty walking. Fatigue. Chills and Fever 102.2 degrees. Brain fog and off-balance could not sleep but no headache. Nausea —no appetite. Nasal congestion and mild cough. Symptoms woke me at 2 am with chills. Took 500 mg acetominophin at 10 am. Forgot to take medication resulted in high heart rate and blood glucose. Symptoms started to decrease after 2 pm 2/28/21. Took 500 mg acetominophin around 3 pm. Fever 100. 5 on 3/1. Fever 100 on 3.2 Felt better but cancelled morning appointment on 3/3. Went for short walk outside on 3/5/21. Did not seek medical care. Still have muscle pain fatigue and brain fog.
67 2021-03-08 blood pressure increased Patient felt woozy after receiving the vaccine while sitting in the waiting area. She was lowered to... Read more
Patient felt woozy after receiving the vaccine while sitting in the waiting area. She was lowered to the floor and her blood pressure was taken, at 104/85. She was sweaty and clammy. Patient stated that she was anxious about the vaccine and something like this had happened before. After laying on the floor she felt better and soon after sat up in her chair. Her blood pressure was taken again and rose to 133/66. She was observed in the waiting area and started feeling better after 15 minutes.
67 2021-03-08 blood glucose increased all of a sudden it's 200 something 300 something and then the last couple days I'm battling 500 and ... Read more
all of a sudden it's 200 something 300 something and then the last couple days I'm battling 500 and something/the ingredients in the shot and it has sucrose; all of a sudden it's 200 something 300 something and then the last couple days I'm battling 500 and something/the ingredients in the shot and it has sucrose; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose of bnt162b2 (BNT162B2; lot number: EL3248; expiration date: unknown) at 67-year-old vaccination age at a single dose in the left arm for covid-19 immunization and sucrose at unknown dosing regimen for an unspecified indication, both via an unspecified route of administration on 30Jan2021. Medical history included diabetes. Concomitant medication included levothyroxine sodium (SYNTHROID) and insulin for diabetes. The patient reported that she received her first dose on 30Jan2021 with no problem at all but this past week her blood sugar levels have been climbing. She normally was 120-150 [unknown unit] then all of a sudden, it's 200 [unknown unit] something or 300 [unknown unit] something and then the last couple days (2021), she was battling 500 [unknown unit] and something. She was just wondered because she looked at the ingredients in the shot and it has sucrose, so she just wondered if that is why her sugar levels are rising. The patient has tried getting hold of her doctor to ask the same question, but her office is closed since last three days, so they didn't have their phones connected. She reported that she did not have issues with the shot, its fine didn't get sick or anything. She's just worrying if that's the reason her blood sugar levels are rising. The outcome of the events unknown.
67 2021-03-08 chest pain, low blood oxigenation, chest discomfort chest pressure/pain, mild hypoxia to 92%, became diaphoretic
67 2021-03-10 palpitations Heart palpitattions which resolved by itself in 10 minutes
67 2021-03-10 fainting syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills... Read more
syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills; mild pain at injection site; This is a spontaneous report from a contactable pharmacist reported for self. This 67-year-old female patient (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 13:45 PM on Arm left via Intramuscular at single dose (Lot # EL9269) for covid-19 immunisation. Medical history included Osteoporosis, known allergies: Sulfa, flu vaccine for immunisation. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), ergocalciferol (VITAMIN D), calcium, magnesium, biotin, bifidobacterium lactis (PROBIOTIC). No other vaccine in four weeks. Past similar reaction from Flu vaccine 8 years ago (2013) for immunisation and treated in ED, had no problems with any other vaccine such as HepB (Hepatitis B), DTAP, pneumococcal 23, Shingrix all for immunization. On 17Feb2021 14:15 PM, feeling of heat rising into throat, then lightheaded- EMT on-site monitored BP, heart, oxygen then administered IV Benadryl and zofran - signed out in 2hr, developed chills and syncope for next 4 days and mild pain at injection site. Self treated with Tylenol/ advised by MD to not get 2nd dose. Events resulted in emergency room/department or urgent care. Treatments were received for the events. Treatment included IV Benadryl and IV Zofran. Outcome of the events was recovering.; Sender's Comments: Based on a temporal association, a causal relationship between the events of feeling of heat rising into throat, lightheaded and syncope, and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-03-11 chest discomfort Chest tightness,air hungry, and anxious.
67 2021-03-11 palpitations Diffuse pruritis within minutes of receiving vaccine. Reported that she had experienced a feeling o... Read more
Diffuse pruritis within minutes of receiving vaccine. Reported that she had experienced a feeling of palpitations and throat swelling 2 weeks following her first dose of vaccine.
67 2021-03-11 deep vein blood clot Sometime in the week following the administration of the vaccine I developed two unprovoked DVTs an... Read more
Sometime in the week following the administration of the vaccine I developed two unprovoked DVTs and one SVT in my left leg and one unprovoked SVT in my right leg.
67 2021-03-12 arrhythmia, fast heart rate Arrived home after vaccination - felt very tired and fell asleep. When I woke around 3:30pm I was ... Read more
Arrived home after vaccination - felt very tired and fell asleep. When I woke around 3:30pm I was experiencing a very rapid heart beat (tachycardia) and my heart was skipping a beat every 10 seconds or so (arrhythmia). I took my blood pressure several times, while seated and at rest and it fluctuated between 180/87 with a heart rate of 74, to 150/94 with a heart rate of 111, to 143/98 heart rate 107 and then to 118/77 with a heart rate of 105. To verify the machine was working, both my husband and son used the same device and their readings were steady and did not fluctuate. I called my GP, who told me to drink lots of water, rest and wait to see with my heart doctor. She also said if my condition got worse to go to the ER. I made an appointment with my heart doctor but he cannot see me until April 7. The adverse event lasted until bedtime. (about 6-7 hourse). I haven't had a problem after that. I since discovered that the CDC changed its recommendation a couple days before I got the vaccine to avoid the shot if I'm allergic to Polysorbate due to PEG being present in the mRNA vaccines.
67 2021-03-14 hypertension, palpitations About 30 minutes post vaccination patient complained of headache and palpitations and was hypertensi... Read more
About 30 minutes post vaccination patient complained of headache and palpitations and was hypertensive. VS were taken and she was given water but symptoms did not resolve
67 2021-03-14 chest pain Approximately 24 hours after vaccine, had symptoms very similar to when I had Covid in January - tir... Read more
Approximately 24 hours after vaccine, had symptoms very similar to when I had Covid in January - tired, queasy stomach, headache, no appetite. Thought I was doing better after 48 hours but had a relapse last night with fever and chest pains. When I take a deep breath, feel pain in my chest.
67 2021-03-14 oxygen saturation decreased ELEVATED TEMP 100.3, SHORTNESS OF BREATH, LOW OXYGEN SATURATION LEVEL, LETHARGY
67 2021-03-14 hypertension High blood pressure occurred day of vaccine
67 2021-03-15 chest discomfort, blood pressure increased BP 142/68; like my throat is closing up; Voice hoarse; chest feeling tight; This is a spontaneous re... Read more
BP 142/68; like my throat is closing up; Voice hoarse; chest feeling tight; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265), via an unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and flu vaccine and experienced allergies. The patient was vaccinated on 05Feb2021. Patient was initially hesitant to get vaccine, reported prior bad reaction to flu vaccine. Patient spoke with the pharmacist and decided to proceed with vaccination. On 05Feb2021, approximately 2 minutes after being seated in the observation area, patient began to feel "like her throat was closing up". Another employee brought the attention of this RN who notified the pharmacist and other clinic staff. Initial assessment, patient seated, in apparent distress stating, "I feel like my throat is closing up". Voice hoarse. 25 mg diphenhydramine hcl (BENADRYL) administered. Patient declined additional 25 mg diphenhydramine hcl stating it made her too sleepy. Patient brought to private monitoring area. VS obtained. HR 78, BP 130/73, SpO2 99%. Reported feeling "some better". HR 76, SpO2 97%, BP 106/66; reported "chest feeling tight". Decision for epinephrine (Epi) administration. Epi Pen administered to L thigh. HR 89, BP 142/68, SpO2 99%. Patient taken to emergency department (ED). Care tx ED RN. Patient stable upon tx to ED. The patient required emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included diphenhydramine hcl and epinephrine. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-03-15 cerebrovascular accident Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and i... Read more
Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and it felt heavy and it just dropped. She then started to raise the arm and she was not able to do it. She then suddenly lost sensation in her left arm. She then could not control it, would raise when it wanted to but was not able to feel it or control it. (had the feeling that it was not connected to her body and it was just floating around). Then started having involuntary muscle spasms in her mid torso region. The same thing then happened again and the muscle spasms were more intense and she waited around and lasted for minutes. She never lost consciousness, but then it happened again and was spreading on her left side. It then encompassed from her hip up to her shoulder. The involuntary muscle spasms were moving from the side toward her chest to where she felt it would impact her breathing. She then went to the ER and they started doing testing, and she had more spasms, and then started having double vision. In talking with the doctor about all of this she had a CVA with complex partial epilepsy with recurrent seizures and that the double vision was related to the infarct in her brain and that the stroke triggered the seizure that she had. She did not lose any memory, loss of consciousness, no weakness or loss of sensation. These episodes only lasted minutes and a refractory time of minutes and when she got to the ER she the other episode when they were trying to test her. They were not able to do the EKG or EEG due to the involuntary movements and these resolved. She is now completely recovered other than the fatigue with no residual. She saw a neurologist on 2/24/21 who felt like that she had a stroke and put her on Keppra and is going to FU in 3 months at IU. It was ruled out that there was no relationship of her transplant to this reaction. She is now on Keppra, Atorvastatin for the swelling in her brain, and also put on aspirin 81 mg. Her blood tests that were done were all drawn and were all within normal limits except for kidney function, but is only a minor #'s for her secondary to the transplant. She then had some titers drawn for CMV and that was also negative. Then she had a COVID test that was negative. Then she had spinal tap that came back normal results.
67 2021-03-15 chest discomfort nausea, dizziness and chest compression with in 15 minutes of shot. oxygen and laid supine flat. I... Read more
nausea, dizziness and chest compression with in 15 minutes of shot. oxygen and laid supine flat. Itchiness within 60 minutes. Benadryl 25 mg. Resolution post shot 3 hours, released home. At 3 PM I experienced chest compression again and used my rescue inhaler with resolution of sx, also took another benadryl Note: I was premedicated with zyrtec and 50 mg of diphenhydramine at the time of the second shot
67 2021-03-16 chest discomfort Left chest pressure and belching episodes.
67 2021-03-17 fainting About 12hours after the vaccination I had a 101.3 fever (normally 98.1) Body aches; when I got up... Read more
About 12hours after the vaccination I had a 101.3 fever (normally 98.1) Body aches; when I got up about 9am the next morning I was dizzy and then fainted. The fever persisted until mid afternoon that day, as did the body aches, and a headache. I spent the day dozing or sleeping. I did eat some oatmeal and have a cup of black coffee about noon. That helped the headache. That evening I was more tired than usual, but no fever or aches. The next day I was also very tired, but I did go to work. The rest of the week I had no energy, but that was the only other side effect. After the first shot, I had only had an achy arm at the injection site that persisted for 2 or 3 days.
67 2021-03-17 coughing up blood post injection patient reported chills headache, runny nose sneezing and coughing for 2 weeks. at da... Read more
post injection patient reported chills headache, runny nose sneezing and coughing for 2 weeks. at day 15 reported coughing up sputum with bright red blood for last 2 days of coughing
67 2021-03-18 heart rate decreased, fibrin d dimer increased Patient is being hospitalized for COVID-19 pneumonia. The patient has had a pulse ox reading in the ... Read more
Patient is being hospitalized for COVID-19 pneumonia. The patient has had a pulse ox reading in the low 90s and feels short of breath. She had a positive COVID-19 test collected on 3/16/21. She has fatigue and nausea/vomiting. The patient received Regeneron antibody infusion and dexamethasone. In ED, patient is requiring 2 L of O2 to maintain O2 saturation of 96%. Patient is being admitted.
67 2021-03-18 chest discomfort Pt developed facial flushing, throat itchiness and "chest tightness" post-vaccination. Pt with repor... Read more
Pt developed facial flushing, throat itchiness and "chest tightness" post-vaccination. Pt with reported history of anaphylaxis. No shortness of breath or chest pain. - Pt given 25mg diphenhydramine - Sxs gradually resolved without further intervention
67 2021-03-18 lightheadedness Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; F... Read more
Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; Freezing and chills; Felt like would pass out/felt so faint; Ate dinner but food came back up; Shortness of breath; Cheeks flushed; Achy; felt draggy/feeling tired; This is a spontaneous report from a contactable. A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: GL9266, via an unspecified route of administration, administered in left arm on 21Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatic fever (occurred age 7), vulvovaginal dryness and sore joints. The patient was negative on Covid test on an unspecified date. Historical vaccine included BNT162B2 on 28Jan2021 for COVID-19 immunisation and flu shot. Concomitant medications included estradiol (IMVEXXY) taken for vulvovaginal dryness; vitamin C [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); calcium. On Monday, 22Feb2021, the patient felt draggy, but did not think it was a big deal. She just thought it was from the shot and was feeling tired. The draggy feeling lasted a few days, but she was unable to clarify outcome further. On Tuesday, she started to feel achy and felt like that too was to be expected. The achiness went away on 25Feb2021. On Wednesday, 24Feb2021, she was really busy. She was still achy but was busy. She also did not drink much water for several hours. It dawned on her later when she was not feeling good. Late Wednesday afternoon it was like everything cratered and she felt horrible. She was feeling bad. She was freezing and had chills. It was a horrible feeling. She helps with her grandkids since she is retired. They were home from school and had to sit on the couch. She felt cold, yucky, and achy. It was a yucky feeling. She went home a couple of hours later. She told her husband she had to lie down on the couch because she felt horrible. She could not further describe horrible feeling. Her daughter had called her as well and was unable to describe how she felt to her daughter. She could only say she felt so sick but could not explain further. She felt awful and could not put her finger on it. She was laying down and when she got up, she felt like she would pass out. At that time, she had not eaten dinner yet. She ate dinner, took one bite and the food came back up. For a few moments she felt so faint, she felt shortness of breath, but it was only for a few seconds. After that, her and her and her husband took a drive to go to hospital. However, by the time she got to hospital she was feeling better. She was also talking to a friend at that time who said all of this was probably form the shot as well. Since she was feeling better decided not to go into the hospital and went back home. At the time she was thinking this was all from the shot and no big deal. On Wednesday night, things got crazy and worse. That evening Wednesday she was getting ready for bed and noticed her cheeks were flushed. On Thursday she got up and noticed rash. She was covered all over her body. It did not itchy really, but it was a rash. Not a bumpy rash, it reminds her of Roseola. Her joints and fingers were starting to swell. Her hands were swollen. It started with her knuckles, it went to her fingers, up to her hands, wrist. Her wrist was sore. Her joint swelling was worse. On Friday, she tried to see her doctor, but could not be seen by the doctor. However, she got in with the PA. When she saw the doctor, it could be seen her hands were swollen. However, the main reason she went to the doctor was due to the rash. However, her joints were sore and swollen. Treatment for rash included Hydroxyzine, for joints and fingers swollen/ wrist was soreincluded prednisone 10mg one tablet every day for five days. The patient recovered from the event felt like would pass out/felt so faint and shortness of breath on 24Feb2021. The outcome of the events joints and fingers swelling/hands were swollen, wrist was sore and cheeks flushed was not recovered.
67 2021-03-18 blood pressure increased, lightheadedness, heart rate increased feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nause... Read more
feeling light headed; mild headache; fatigue; erratic bp/ spike in her blood pressure; feeling nauseous; accelerated HR; she had body shakes/body was trembling; to the point she thought she was going to pass out; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL1284) at vaccination age of 67-year-old via an unspecified route of administration on 28Jan2021 at a single dose to prevent COVID19 (covid-19 immunisation). Medical history included interstitial lung disease and overactive thyroid (She was treated for overactive thyroid, but it has been stable for five years). Concomitant medication included nitrofurantoin for interstitial lung disease and fluticasone. The patient previously took prednisone [prednisone acetate] (She did ten weeks of Prednisone and has been off Prednisone since the middle of Nov2020. She started at 30mg and tapered down to 20mg then to 10mg and then to 5mg until she was done). The patient experienced feeling lightheaded, mild headache, fatigue, erratic bp 01Feb2021 11:30, feeling nauseous on an unspecified date in 2021. Took Pfizer Covid 19 vaccine last week. Began feeling lightheaded, mild headache, fatigue, erratic BP on Monday, 4 days after receiving the vaccine. Went to Emergency department on Monday evening. Has been continuing off and on since Monday. Can these symptoms occur after 4 days patient questioned. Has already reported to DSU. She got Pfizer's COVID19 Vaccine a week ago today. She was doing fine and then Monday she started with mild headache, erratic blood pressure readings. She ended up in the ER because it was so high. It stabled out and she went home. She was feeling ok on Tuesday, but not quite normal. She was fine yesterday until last night then it started again with erratic blood pressure, fatigue, mild headache and lightheadedness. The headache is never pounding. The lightheadedness won't go away. Is that normal to have that many days after receiving the vaccine? It was four days before she started experiencing it. Now she feels kind of normal as long as she is laying down except for headache. As of 15Feb2021, the patient reported that she called a couple weeks ago and reported adverse side effects and she needed a couple questions answered. She mentioned that she was due to have the second vaccine this weeks (18Feb2021). She was extremely worried about doing it because even some of the effects she had after 4 days in the first vaccination have not subsided. She added that it landed her in emergency room a couple of times (also reported as ended up in the ER twice). She inquired if should she take the second one at this point or can she wait and if she can wait for how long. She mentioned that she had a spike in her blood pressure (BP), she had accelerated HR on an unspecified date in 2021, she was very lightheaded to the point she thought she was going to pass out on an unspecified date in 2021. The second time around, her body was trembling on an unspecified date in 2021, she had body shakes. It was not fun. All of these effects have returned to somewhat normalcy, but she is still experiencing lightheadedness. She has seen her own physicians, but she is not sure if she should proceed with the second vaccine. The outcome of the event lightheadedness was not recovered while the outcome of the other events was recovering. Follow up (15Feb2021): New information received from a contactable consumer (patient) included: lab data, new event (accelerated HR, to the point she thought she was going to pass out, body shakes/trembling) and clinical course of the events.
67 2021-03-20 chest discomfort -About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wr... Read more
-About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wrap around my diaphragm up to my collar bone, as if my breath was being taken away. I yelped out but the three people in the car with me did not here me. I remained calm took a deep breath- feeling went away. - Had vaccine on Saturday. Woke up in the night on Sunday night, feeling like my tongue was swelling and my throat was closing up. I took 1/2 Benadryl and used Albuterol enhaler. Temp was 99.8 (my average at home is 96.5)Fell back asleep. Woke up the next day and was fine. - other symptoms were tiredness, headaches, achy joints, which went away fairly as quickly. -since the vaccine I have had a bad outbreak of do
67 2021-03-20 palpitations, heart rate increased About 5 minutes after getting shot, patient had extremely rapid heart rate feeling like pounding out... Read more
About 5 minutes after getting shot, patient had extremely rapid heart rate feeling like pounding out of her chest, Patient denies feeling dizzy or faint. Later that day experienced swollen lymph nodes.
67 2021-03-20 fainting, chest pain Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradu... Read more
Bad taste in mouth followed by increasing chest pain. B/p 200/100 (nl low) increase chest pain gradually better over 45?. Tried to leave didn?t get out of bldg, collapsed in chair bad chest pain felt really bad. Ambulance called, gradually progresses to weak r side hi b/p slurred stammering speech inability to swallow tongue thrusting to Uc health ct w contrast ok. Gradually improved discharged at 1700. Saw doctor following Monday. Cardiac work up scheduled 4/5/21 She does not want 2nd vaccine until cleared by cardiologist. I have had bouts of chest pain. Hospital tadmitted me as Jane doe. Severe fatigue sleeping 12-14 h/ d for 5-6 d no fever flu sx. Low energy. Hospital never took he from me once better discharged as migraine but I don?t have migraines
67 2021-03-20 heart rate increased I became very dizzy. My heart rate was very fast. My blood pressure was 157/82. My normal blood pres... Read more
I became very dizzy. My heart rate was very fast. My blood pressure was 157/82. My normal blood pressure is 120/70 I had chills, and tired
67 2021-03-21 palpitations Patient feeling very anxious, shortness of breath, headache, and palpitations. Patient was trembling... Read more
Patient feeling very anxious, shortness of breath, headache, and palpitations. Patient was trembling. She denied any history of diabetes. Patient stated that she has many severe allergies (did not verbalize to what specifically even when asked) and even carries her own epi pen. She acknowledged that this did not feel like an allergic reaction and more like symptoms of anxiety. Patient refused EMS and stated she wanted to wait to see if she could calm down. Second RN and Pharmacist were called for assistance. Pulse ox was placed on patient and O2 Sats ranged from 94-97%, HR 90's. Patient stated she had history of HTN and asked for her BP to be taken d/t her headache. BP was 128/85. After about 20 minutes of close monitoring, patient stated that she was starting to feel better and trembling decreased. Patient remained in observation area for 30 more minutes and left in stable condition after all symptoms had subsided.
67 2021-03-21 fainting Terrible panic attacks,depression,faint,lightheaded
67 2021-03-23 chest pain 1/11 vaccination 1/15 COVID - 1/18 I had a scheduled colonoscopy at 10AM. Close to 11AM, started IV ... Read more
1/11 vaccination 1/15 COVID - 1/18 I had a scheduled colonoscopy at 10AM. Close to 11AM, started IV sedation, put me on my side. I remember gagging and then i woke up. My chest was burning and they were talking to them, OZ mask because SPO2 had dropped to 48. They needed to monitor me longer, took to recovery, and put on bronchodilator (?) thru the O2 mask. They started and IV antibiotic for 90 minutes. SPO2 went back to 98. I went home, felt weak. The Dr said to take it easy next couple of days. Work stated to only come back when feeling normal. My husband tested for COVID 20th. 1/26 I tested COVID +. I felt like it would be negative due to having both vaccines but it wasn't.
67 2021-03-23 hypertension Flushing, hives, rash, itching, lips swelling tingling, high BP dose 1 - 209/107 high BP dose 2 188/... Read more
Flushing, hives, rash, itching, lips swelling tingling, high BP dose 1 - 209/107 high BP dose 2 188/87. Symptoms began 30 -40 minutes after vaccines.
67 2021-03-23 pulmonary embolism The evening of 23 Dec 2020 I developed sudden shortness of breath with exertion and was unable to wa... Read more
The evening of 23 Dec 2020 I developed sudden shortness of breath with exertion and was unable to walk to my car in a hospital parking lot without stopping twice. SOB progressed over next few weeks and I sought medical attention.
67 2021-03-23 chest discomfort chills, fever of 101.6 with Tylenol on board, headache, chest tightness, nausea, malaise
67 2021-03-23 palpitations racing heart around 6:00 pm, lasted a few minutes. have had anxiety over it. I went to my doctor. ... Read more
racing heart around 6:00 pm, lasted a few minutes. have had anxiety over it. I went to my doctor. all my vital signs were good. could be anxiety caused it?
67 2021-03-24 heart rate increased Couldn?t swallow good, itchy ears and throat, blood pressure 170/87 , elevated heart rate, numb lips... Read more
Couldn?t swallow good, itchy ears and throat, blood pressure 170/87 , elevated heart rate, numb lips, bad headache. I received a shot of benedryl and steroids.
67 2021-03-24 chest discomfort Headache 3 days tightness in upper chest from shoulder to shoulder for 3 days
67 2021-03-24 heart rate increased Minimal reaction the first 2 days after receiving the shot. on the 3rd day I became fatigued but not... Read more
Minimal reaction the first 2 days after receiving the shot. on the 3rd day I became fatigued but noticed some lower abdominal discomfort. 4th day had loose stools and noticed some burning when urinating.. Late in the day had a splitting headache, i never get headaches, took Tylenol and felt better. At 2 am that night woke up with teeth chattering and limbs shaking. Urinated and noticed a pink tinge. My husband took me to the ER ( He had had a similar reaction to his first Pfizer shot) Found to have a fever, increased heart rate and a raging bladder infection (significant amount of blood in urine). Treated with Keflex via IV . Went home with a presciption for Keflex They are running a culture. I HAD COVID IN NOVEMBER AS DID MY HUSBAND IT APPEARS THAT MAYBE ONE DOSE WOULD HAVE BEEN SUFFICIENT FOR US. I HOPE THIS WILL BE EVALUATED AND THE PUBLIC INFORMED OF BEST PRACTICE
67 2021-03-25 chest discomfort 10 pm of 3/23 I started feeling headache and muscle pain. By 4:30 3/24 I was in great pain across m... Read more
10 pm of 3/23 I started feeling headache and muscle pain. By 4:30 3/24 I was in great pain across multiple locations across my body. I also had a heaviness in my chest, making it uncomfortable to breath.
67 2021-03-25 cardiac arrhythmia, heart rate increased, palpitations 5 hours after shot my heart began racing to 195 beats /minute with palpitations. After about an hou... Read more
5 hours after shot my heart began racing to 195 beats /minute with palpitations. After about an hour of this I went to ER and had an EKG resulting in multiple PVCs that did not abate.
67 2021-03-25 fainting Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized ac... Read more
Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized aching; Fibromyalgia flare up; No energy been very tired; No energy been very tired; Felt like she was going to faint; Dizziness; Vision blurred; Loss of appetite; Flu-like symptoms; Hands feel warm to touch, but she still feels cold; She cannot sit or stand without discomfort in her spine; She cannot sit or stand without discomfort in her spine; Sick; Her bones and muscles hurt; Her bones and muscles hurt; Wheezing; This is a spontaneous report from a contactable Other HCP, the patient. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE,Lot Number: EM9809; Expiration Date: 30Jun2021), intramuscularly, on 01Mar2021 at 13:45 (at the age of 67 years old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included having become disabled in 2009, arrhythmia from 2014 and ongoing which was diagnosed after she took a Hep C treatment (Sovaldi, Ribavirin, Olysio). She had to take these medications for five months, where most people have to take it for three, ongoing allergic asthma - allergic to "everything." She has had this her whole life, diagnosed when she was 5. Started treatment with steroids at 16 , Hepatitis C from 1996 to 2014 diagnosed 4 years after blood transfusions Could have already gotten it as a nurse, was much more resistant than the average person 5 weeks to go negative, ongoing hepatic failure from 2013- she went into liver failure from Hep C. An event occurred- exposure of a deadly toxin that came from China, ongoing fibromyalgia from 1992 -Immediately after blood transfusions when her son was born- Gave her the correct blood but her body reacted. Flu shot in Early Oct2020 Fibromyalgia flare up, 4 times the dose (as reported)- Onset Age 66, Seizure disorder which was diagnosed in 2016 after disseminated shingles; after 2.5 months started having black outs where she did things and said things no memory of, the only way she knew it happened is if there were consequences. Doesn't know if she still has those, but she is getting an MRI and EEG. She lost vision in her right eye 2 years ago due to retina surgery macular pucker. She thinks her liver was stealing Vitamin A from her eye. Medical history also includes she ran over herself with her car, blood pressure abnormal, hepatic encephalopathy, autoimmune thyroiditis, and anxiety all from unknown dates and unknown if ongoing. The patient has had cataracts since an unknown date prior to the vaccination. The patient was diagnosed with "Rocky Mountain" in 2009. She also mentioned that when she got the vaccine she did not tell them that she was on steroids and an antibiotic. She commented that she was not in good shape when she took the vaccine to begin with. She is immunosuppressed and thinks that she should not have received the vaccination. But she also stated that she took the vaccine because she is a severe asthmatic and does not have a strong immune system so if she got COVID, she would die. Concomitant medication included benazepril (BENAZEPRIL) for blood pressure abnormal from an unspecified start date and ongoing; amlodipine (AMLODIPINE) for arrhythmia from 2014 and ongoing; rifaximin (XIFAXAN) for hepatic encephalopathy from 2014 and ongoing; lactulose (LACTULOSE)for hepatic failure, ammonia abnormal from 2014 and ongoing; levothyroxine sodium (SYNTHROID) for autoimmune thyroiditis from 1984 and ongoing; omeprazole (PRILOSEC [OMEPRAZOLE]) for reflux gastritis, chronic gastritis from an unspecified start date and ongoing; alprazolam (XANAX) for anxiety, post-traumatic stress disorder from 2009 and ongoing; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) for asthma from an unspecified start date and ongoing; ranitidine (RANITIDINE) for an unspecified indication, start and stop date were not reported.The patient previously took flu vaccine vii, olysio for hepatitis c and experienced histamine level increased, lyrica and experienced weight increased. Ten minutes after the vaccine was administered the patient experienced generalized aching on 01Mar2021 at 13:55 with outcome of not recovered. After twenty minutes she developed a pretty severe headache on 01Mar2021 14:05 with outcome of recovering. After 30 minutes she stared to feel nausea on 01Mar2021 at 14:15 with outcome of recovered. She stated that when she stood up to leave felt like started to feel dizzy on 01Mar2021 with outcome of unknown, and felt like she was going to faint on 01Mar2021 with outcome of unknown, her vision blurred on 01Mar2021 with outcome of not recovered and she had trouble getting into the elevator. She also experienced a loss of appetite on 01Mar2021 with outcome of recovering. The patient continued to describe her experiences noting that "things changed daily" and mentioning that she experienced fibromyalgia flare up on 01Mar2021 with outcome of not recovered, no energy been very tired on 01Mar2021 with outcome of not recovered , no energy been very tired on 01Mar2021 with outcome of not recovered , couldn't get warm- very cold, her skin was very cold on 02Mar2021 01:30 with outcome of not recovered, flu-like symptoms on 01Mar2021 with outcome of recovering, hands feel warm to touch, but she still feels cold on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, sick in Mar2021 with outcome of unknown, her bones hurt in Mar2021 with outcome of unknown, her muscles hurt in Mar2021 with outcome of unknown, wheezing on an unspecified date in Mar2021 with outcome of unknown. Lab tests and procedures included cardiac output: over 50 percent, echocardiogram: her heart was good and clear, electroencephalogram with unknown results, magnetic resonance imaging with unknown results, all on unknown dates. Therapeutic measures were taken as a result of pretty severe headache; Sender's Comments: Based on the available information, the company considers that a causal relationship between generalized aching, severe headache, feel dizzy, going to faint, vision blurred, no energy been very tired, very cold, her skin was very cold, wheezing and bnt162b2 vaccine cannot be excluded due to plausible temporal association. The Company considers the reported event fibromyalgia flare up is unrelated to bnt162b2 vaccine but more likely due to underlying medical history of ongoing fibromyalgia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-03-25 blood pressure increased Pt arrived at observation area. at around 8:45 am. At 08:53, the patient stated 'I feel dizzy" Pati... Read more
Pt arrived at observation area. at around 8:45 am. At 08:53, the patient stated 'I feel dizzy" Patient lower extremities elevated on a chair. V/S obtained BP 152/88, P-61, SaO2 100%. Pt denied anu other concerns but stated B/P usually 120/70.. POC glucose obtained by EMT. Result 103. Apple juise and Graham crackers given to patient. Pt. stated she has eaten this am but was thirsty. 0905- Pt remains stable with c/o dizziness at same level. VS 151/86, P-60 Sats 100%. Pt. given small bottle of water. Pt. stated she had been under moderate stress due to a recent release from employer. She denied any chronic conditions other than HTN. 09:20- Pt. states she is 'still dizzy' this is what happened last time" EMY and writer continue to monitor Monitoring patient at present.. VS improving. Pt states level of dizziness unchanged. BLE remain elevated on chair. Stated she 'felt a headache coming on'. VS 140/81, P-62, Sats 100% 09:46- Recheck of vital signs- 145/87, P-61, Sats 100% Pt stats she is starting to 'feel better' juice pak, small bottle of water and @) graham crackers consumed. 10:00- Pt has felt 'well' and wants to leaved. VS stable. B/P 147/68, P-61, Sats 100%. Writer walked with pt. to elevator. Tolerated well. Denies any issue of dizziness.. Pt. discharge to home. All questions answered. Impression- vertigo and elevated blood pressure related to anxiety. Pt advised to follow up with her MD. Also advised to call 911 if symptoms return. Pt verbalized understanding of all information.
67 2021-03-25 chest discomfort The patient reports a severe allergy to Corn/corn syrup. S: I feel itchy and nauseous. I feel like... Read more
The patient reports a severe allergy to Corn/corn syrup. S: I feel itchy and nauseous. I feel like my chest is heavy. Denies CP or SOB. Denies dizziness or lightheadedness. O: A&O x3. Skin is pink, warm, and dry. No rash. Resp: normal resp rate- no cough no stridor. Cards: RRR in the 80s. Radial pulse palp. A/P: 67 y/o female who reports severe Corn allergy and is having symptoms of s/p Pfizer vaccine that are similar to when she ingests corn or corn derivative. She takes Cetirizine when this happens but does not have any with her. Cetrizine 10 mg po x1 given Patient monitored for 30 min with a resolution of reported symptoms
67 2021-03-25 skin turning blue Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyan... Read more
Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyanosis. EMS gave breathing tx, 02 sats WNL. Declined transfer to hospital at that time for fear of Covid. Client exhibited confusion, oriented x 0, short term memory loss. Bronchial spasms resumed, EMS again called, transported via EMS to hospital. Diagnosed with transient global amnesia and hypercapnia. Client was transported to medical center for CT and MRI for r/o stroke. Stroke was ruled out. Client with c/o memory loss, confusion, and h'a are becoming less severe. Client states that senrory processing is slowed.
67 2021-03-25 heart rate increased fatigue, headache 6 hrs after vaccine (same as 1st dose), ~11 pm, severe chills, nausea, joint pai... Read more
fatigue, headache 6 hrs after vaccine (same as 1st dose), ~11 pm, severe chills, nausea, joint pain, short of breath ~ 2 am increased heart rate (112, usually in 80's) fever over next 3 days fever, joint pain, injection site redness and area on arm below -day - continued redness in arm
67 2021-03-25 fast heart rate presents to the ED with SOA that began at midnight tonight while getting ready for bed. Following th... Read more
presents to the ED with SOA that began at midnight tonight while getting ready for bed. Following the onset of the SOA she began to have diaphoresis, lightheadedness, and a burning sensation in her chest that radiates to her back. No nausea or vomiting. She reports checking her heart rate and was tachycardic. She tried to bare down and walk off the tachycardia, with no relief. While she was driving to the ED, her symptoms gradually resolved
67 2021-03-27 troponin increased, blood pressure increased, chest discomfort, heart attack, inflammation of the pericardium 3 phases- within 24 hrs of shot - low grade fever and chills lasting 24 hours; during the following ... Read more
3 phases- within 24 hrs of shot - low grade fever and chills lasting 24 hours; during the following 2 weeks, strong pain in arm muscle that travelling under arm into lymph nodes. Approximately 30 days after injection experienced a mild heart attack and unexplained pericarditis. Symptoms at onset were major pressure in chest and elevated blood pressure 210/99. Prescribed blood pressure medication, blood thinners and 4 does of indomethacin for pericarditis
67 2021-03-29 chest pain, cerebrovascular accident, chest discomfort Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I t... Read more
Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I thought I am going to have a stroke; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; Chills; Headache; The chest pain was horrible; The joint and muscle pain were so severe; I am still little real nauseous; I feel like I mean like acid coming up constantly making me more nauseous; Unable to eat; The joint and muscle pain were so severe; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication includes supplements and multivitamins. The patient stated "I wanted to ask you and I have some horrible concerns I got my second COVID shot last Friday, and by Saturday night, I am not exaggerating, my symptoms were so severe I felt like I was going to die I mean literally die on 20Mar2021. I couldn't get to emergency room, I figured out I am just going to die, I just laid down and let my door open down so somebody could find me, the symptoms I was having was extreme nausea, chills, headache, the chest pain was horrible, horrible, the headache I mean I thought I am going to have a stroke, the joint and muscle pain were so severe. So I have been taking Tylenol, Advil (Treatment) finally this morning, yesterday was tiny, tiny bit better, this morning its little bit better but I am still little real nauseous and I feel like I mean like acid coming up constantly making me more nauseous and almost like unable to eat. Ever since Saturday all I will have been doing is three bites of chicken soup three times a day. What in the world is going on with this vaccine that it would cause those severe symptoms and my chest is still tight I still feel low congestion having hard time taking a deep breath in Mar2021". The outcome of the event "my symptoms were so severe I felt like I was going to die I mean literally die" was recovered on unspecified date. The outcome of the event unable to eat was unknown. The outcome of the rest of the events was recovering. Information on lot/ batch number has been requested.
67 2021-03-29 pulmonary embolism My wife had several blood clots in both lungs. She is now on blood thinners after spending 1 week in... Read more
My wife had several blood clots in both lungs. She is now on blood thinners after spending 1 week in the hospital.
67 2021-03-29 pulmonary embolism, deep vein blood clot, low platelet count Patient presented 8 days after her vaccine with fevers and lethargy. She subsequently developed DVT,... Read more
Patient presented 8 days after her vaccine with fevers and lethargy. She subsequently developed DVT, PE, and severe thrombocytopenia consistent with ITP. She has also developed encephalitis.
67 2021-03-30 nosebleed Fifty hours after injection I had a mild nosebleed; This is a spontaneous report received from a Pfi... Read more
Fifty hours after injection I had a mild nosebleed; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration in the right arm on 10Mar2021 10:00 (at the age of 67-years-old) as single dose for COVID-19 immunization. Medical history included breast cancer, high blood pressure and drug allergy to some medications, all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included lisinopril and tamoxifen. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient stated that fifty hours after injection (12Mar2021, 12 noon) she had a mild nosebleed. However, it was also reported that the mild nosebleed started on 12Mar2021 at 11:30 PM. At 11:30 (as reported), she was awakened with a gushing nosebleed. They couldn't get it stopped so they had to call the squad. The patient stayed in emergency room/department or urgent care for several hours to get it under control. The patient received some type of syringe medication reported as "Afrin packaging" as treatment for the event. The event of nosebleed was considered as non-serious by the reporter. The patient had no history of problems with nose bleeds. It just seems coincidental to receiving the vaccine. The patient wanted to make sure it was safe for her to get the second dose. The patient underwent COVID-19 test type post vaccination via nasal swab on 24Feb2021 which resulted to negative. The outcome of the event was recovered. Follow up attempts are needed. Further information has been requested.
67 2021-03-30 blood clot I had a return of a superficial thrombophlebitis on my left arm above where a catheter had been when... Read more
I had a return of a superficial thrombophlebitis on my left arm above where a catheter had been when I had surgery 7 weeks before. The blood clot returned again to the same level of pain and the same; I had a return of a superficial thrombophlebitis on my left arm above where a catheter had been when I had surgery 7 weeks before. The blood clot returned again to the same level of pain and the same; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Mar2021 13:30 (lot/batch number was not reported) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure. The patient had no known allergies. The patient's concomitant medications were not reported. On 04Mar2021 07:30, the patient had a return of a superficial thrombophlebitis on her left arm above where a catheter had been when she had surgery 7 weeks before. The blood clot returned again to the same level of pain and the same. No treatment was received for the events. Patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and not tested for COVID post vaccination. Vaccine facility type was other. There was no other vaccine in four weeks and there was other medications in two weeks. The outcome of the events were not recovered. Information on the lot/batch number has been requested.
67 2021-03-30 platelet count decreased also had a headache; her eyes have been really sore, red and she has several broken blood vessels in... Read more
also had a headache; her eyes have been really sore, red and she has several broken blood vessels in her eyes; her platelet levels dropped; having muscle pain or some kind of pain, maybe joint pain that is in her hips; has had nausea and she has generally felt unwell; muscle pain; she slept for almost two days; felt unwell; diarrhea; abdominal pain; her eyes have been really sore, red and she has several broken blood vessels in her eyes; her eyes have been really sore, red and she has several broken blood vessels in her eyes; tiredness; eyes were yellow when she woke up that morning; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), first dose via an unspecified route of administration, administered in Arm Left on 09Mar2021 11:45, single dose as SINGLE DOSE for covid-19 immunisation. Medical history included lung transplant from May2011, immunodeficiency from May2011 and ongoing, strokes. The patient had dtap vaccine before Jan2021. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); prednisone acetate (PREDNISONE); tacrolimus monohydrate (TACROLIMUS). Patient reported that it has been about a week and a half of maybe more since her first COVID vaccine and she gets new symptoms almost everyday. Most of the symptoms aren't like put-you-down sick, horrible symptoms, they can be dealt with, but she has had a lot of them. She never got injection site pain and her arm never got sore. She had tiredness on the second day after her COVID vaccine, she slept for almost two days. She has a headache almost constantly. She is having muscle pain or some kind of pain, maybe joint pain that is in her hips. She doesn't have chills, a fever, injection site swelling or redness. She has had nausea and she has generally felt unwell all the time for a week and a half now. She is immunocompromised because she has had a lung transplant, that is the one thing that probably sets her apart is that she is immunosuppressed. She had the lung transplant almost 10 years ago now and she has been doing well. She is not on blood thinner medicine but she does take a baby aspirin everyday. Those are the only two things that she can think about. She doesn't know if all of that would make the symptoms from the COVID vaccine different for her. Most people she knows who have received the COVID vaccine have only had a couple days of tiredness and a sore arm. But she has a headache, been achy, and she just doesn't feel good. She also had a headache then and slept a lot, she was really tired. Later in the report caller clarified the first dose was actually 09Mar2021. She is not tired right now but she does still have a headache today, it is a pretty good headache. Her tiredness was Sunday and Monday of this week, confirmed to be 14Mar2021 and 15Mar2021. She says that she has recovered completely from the tiredness even though she feels like she could nap right now but she can't since she has a blood draw later. It is like she wakes up and every day she gets new symptoms. She had two symptoms that are not on the sheet of symptoms. The two she experienced are weird. On Saturday, a week and a day after her vaccine, her eyes were yellow when she woke up that morning. Confirmed date to be 13Mar2021. It was only that one day. She thinks that she has recovered completely. Also, her eyes have been really sore, red and she has several broken blood vessels in her eyes. Some of this is normal in the winter for her, but the yellow isn't normal for her. Normally, when she does get the blood vessels in her eyes they will heal in a day or so but the ones now have lasted much longer. They have been much slower to go away. It is not like there is a red spot, but it looks kind of red and kind of weird. The other symptom that is strange is that her platelet levels dropped. She was at 49 before her COVID vaccine and now her platelet level is down to 29. She does have normally very low levels for platelets but they are usually around 50. They have dropped substantially since her COVID vaccine. They dropped from 50 to 33 and then 5 days later her level went to 29. She is getting another platelet level drawn today, confirmed to be 16Mar2021. Her eyes being sore, red, and having broken blood vessels occurred probably a couple of days after she received the COVID vaccine. Specifically, her left eye felt like it had something in but she doesn't believe that it did. She used eye drops. Her eye just felt gritty. This is not like she had pink eye and she didn't wake up with this eye shut. It wasn't pink eye she knows what that is like. Her eyes had broken blood vessels and then they turned yellow then they turned red and have remained red. They are not sore today and she doesn't feel like she has gravel in her eye but the whites of her eyes don't really look clear. She says so far it has improved some but she will see since she wakes up every day and something new has happened, or something different or something has come back again. The good news is that she doesn't have all of these symptoms at the same time. She can't the remember the day pain in hips began but it is ongoing. She noticed this morning that the pain in her hip was not as bad when she had gotten out of bed. That pain has lessened there but the pain went to her head. Nausea and generally not feeling well: Probed for when this began and caller says that it has occurred for several days after she eats dinner, her stomach will be growling loud and that comes along with abdominal pain which doesn't really fit in with muscle or joint pain, she has no muscle there unfortunately she jokingly says. Sometimes this is all accompanied with diarrhea. It is not ongoing as of now, no date provided. She noticed that it comes and goes and sometimes she can eat and she is fine and sometimes she gets really sick feeling. It seems like if she doesn't eat then she doesn't get the symptoms but she knows that she needs to eat. Investigations: Her doctor has been having her do platelet blood tests about every 5 days since she took the COVID vaccine. She does not remember the dates of these tests off of the top of her head. She had a blood draw at the clinic the day before her COVID vaccine and her platelet count was 49 on 08Mar2021. For the result of 29 that was either last Thursday or last Friday, 11Mar2021 or 12Mar2021. Te outcome of the event scleral discoloration was recovered on 13Mar2021, tiredness was recovered on 15Mar2021, headache was not recovered, pain in hip was recovering, other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299104 similar report from same reporter
67 2021-03-30 loss of consciousness passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she ... Read more
passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she was dehydrated in hospital and did not eat a thing; stayed dizzy; confused; She had felt disoriented; foggy; it was like the flu shot; sleeping a lot; her vision would get very narrow; thumb pink; erratic body temperature; horrible headache; bodyaches; dry heaves; slight fever/ body temperature 104.4; injection site sore; lymph nodes swollen; This is a spontaneous report from a contactable consumer (patient). The 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 04Feb2021 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer - stage 2 from Jan2008; 29Jan2008 surgery, breast cancer. First surgery for breast cancer removal and lymph node removal, then the cancer went around the first and second lymph nodes so they had to go back in because they had to take out a bunch more and she had to give them permission to take out more lymph nodes. Concomitant medication(s) included ongoing simvastatin for High cholesterol; ongoing bifidobacterium bifidum, bifidobacterium longum, lactobacillus gasseri (PHILLIPS COLON HEALTH) she has high pain tolerance, had stomach cramp did not know what it was and one a day vitamin. The patient previously took bnt162b2 (BNT162B2), dose 1 intramuscular administered in Arm Right on 14Jan2021 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunization and experienced Injection site sore. The patient experienced passing out on 28Feb2021, injection site sore, lymph nodes swollen on 04Feb2021, thumb pink on 26Feb2021, erratic body temperature, horrible headache, bodyaches, dry heaves on 05Feb2021, she was 155 lbs before when she was in the hospital - and now 160 lbs on an unspecified date. The patient was hospitalized for passing out from 01Mar2021 to 02Mar2021. The event passing out leaf to emergency room visit. The patient lab tests and procedures which included cat scan/ cat scan groin area with contrast: normal; EKG: normal; blood workup: normal; Blood culture:normal, all on 01Mar2021; cat scan head and neck with contrast: normal and cat scan head and neck without contrast:normal on 02Mar2021. The outcome of the event thumb pink was recovering, erratic body temperature was not recovered, horrible headache, bodyaches, dry heaves recovered on 26Feb2021, and was unknown for the rest events. Reported as: Caller states that on 04Feb2021 she received her 2nd vaccine at around 3:30 pm, and then around 10 pm she had injection site soreness. The morning after the second injection around 4 am, she had site on her arm soreness, erratic body temperature with slight fever, horrible headache, bodyaches, and dry heaves. Her lymph nodes also swelled up again. Caller clarifies that this also happened after her first injection of the Pfizer Covid19 vaccine and on a similar timeline. Caller clarifies that 2 weeks later on 26Feb2021 she had ended up with horrible headache, dry heaves, headache, body temperature 104.4. She states that this lasted Friday night and Saturday night and Sunday she was feeling better. Clarifies that was the week of 26Feb2021. Caller states that her events were on a similar timeline and that her first vaccine was 14Jan2021 at 3:30 pm on Thursday. States that by 10 o'clock that night, injection site was sore. At 4 am, injection site was very sore. A couple of days later, her lymph nodes were swollen in her left leg, groin area, right arm under armpit. Adds that area under armpit was the size of her thumb. Also, on the left underneath her chest wall. She states that she has had breast cancer in that left breast. She states that the swelling went away completely, but that the groin area swelling took 2 weeks to go away. Unable to verbalize exact dates. Confirms that this was after the first vaccine and also occurred after the second vaccine. Caller then adds that she was feeling better Sunday, 28Feb2021 but that her husband then found her on the floor Sunday night at 8:45 pm. She states that she passed out. Monday she passed out again and was taken to the hospital where she stayed until 02MAR2021. Healthcare Provider also provides information that her son ran her to emergency room, and she is not familiar with the doctors there. Also, a doctor that she does not remember the third physician but it was a neurologist. Caller states that she was 155 lbs before when she was in the hospital - and now 160 lbs. States that she was dehydrated in hospital and did not eat a thing. Normally she runs around 160 lbs. States she had breast cancer so left arm cannot be used, so they used her right arm for both vaccines. caller adds that she had a cruise she was going to go on but refused to go on in 2020. States that she heard you will need to have a vaccination passport to travel in the future so she wanted to get vaccine. States she did not want to get covid. States that so many people have died. Caller clarifies that she was admitted to (Hospital Name) on 01Mar2021. Caller adds that she went to the hospital 2 weeks after the second dose. She states that is what makes them wonder if it is from the Covid vaccine. Adds that she is not saying that is what caused all of this, but that it is just a coincidence that it was exactly 2 weeks after the vaccine, exactly 2 weeks out when this happened. She states that she has been thinking if she should be wasting Pfizers time reporting this but it could be a coincidence or maybe a reaction. Caller adds maybe it is because she had 34 radiations, 8 chemo treatments, 1 year of Herceptine, and breast cancer. States that maybe she can save somebody else, or if a possibility, people can be prepared two weeks early. She adds that she is lucky she did not break an arm, leg. or bone. States that she doesn't know if maybe she can save some other person by sharing this information. Injection site sore: States that this was after both first and second vaccine. It stayed sore for about a week, and was just tender after that. If she touched it, she noticed, but it didn't hurt her from doing anything. With the first vaccine, injection site soreness started 14Jan2021 around 10 pm and completely resolved after about a week. She adds that with the second vaccine she also noticed injection site soreness that same day on 04Feb2021 around 10 pm also. She adds that it lasted about six days or seven days or so. It was the same way, tender the first day and then at 4 am was when it got really bad. That Friday 05Feb2021 was when it hurt worse. Adds that she went into hospital on 01Mar2021 on Monday. States she was feeling okay, stayed dizzy and confused and thought she was getting Alzheimer's or dementia but it cleared. At 11 pm on Sunday felt completely different, like the old her. States she was fine yesterday 15Mar2021. She had felt disoriented but is now feeling better and back to normal. Eratic Body Temperature: States that she started watching and recording her body temperature on 09Mar2021. She states that it was 104.5 on Friday, and Saturday and Sunday night she used a wet washcloth to her forehead. States that her body temperature initially was variable starting on 26Feb2021. She adds that it continued until Sunday 28Feb2021. On 26Feb2021, her body temperature was 104.5. She states that it was then low on Sunday 28Feb2021 and was 98 or 99. Adds that it had been erratic but that once the fever broke it has been between her normal which is 98.6 to 98.7. Adds that her and her husband know for sure that when she passed out the three times, her temperature was 94.4. States that her husband gave her aspirin for the temperature. Adds that her temperature has been between 97.9 to 94.9 and dropped to its lowest on Saturday 13Mar2021 at 10:35 am. She states that it is still doing this erratic behavior and that this morning it was 96 at 1 am and then 96.8 at 8 am. While on phone today, it is 97.1. Lymph nodes swollen: States noticed swelling at 4 AM 16Jan2021. States this occurred 4 am after both first and second injection. Occurred to groin area, right arm, and left arm. It was there for a couple of days and then it would just remind her it was there. The arm lymph node swelling went away after a few days, maybe before a week or so. The one in the groin was there for about two weeks. On a scale of 1 to 10, it was a 1.5 and was not something that people need to take an Advil or something for. Clarifies it was in the armpit except in the left side because they took those lymph nodes out during surgery in 2008. Also, she noticed lymph node swelling in the chest area. Lymph Nodes at second vaccine she also noticed them starting at about 4 am after the vaccine and it started hurting again. Caller reiterates both shots were given at 3:30 pm and then at 10 pm injection site gets sore.Then 4 am injection site gets more sore. She's been telling everybody to get the vaccine in the morning. Her symptoms lasted two weeks and then she was fine. Caller adds that her husband never felt a thing from receiving the vaccine. She states that the injection site was tender on her husband but gone the next day. Investigations: stated they looked at her in the hospital and said she was fine. The girl came back up and did more cultures and nothing grew. They were confused and so was she and she has been debating whether to call and waste time reporting but thinks that Pfizer needs to know what happened to her. Simvastatin: Adds that asked doctor if this caused her symptoms and he said no. Phillips colon: doctor 6 to 9 months later did scan, the next day was in emergency surgery and it was her appendix. It enlarged and had grown into the other organs. Doctor said it was a mess and it was ready to rupture as a precaution they wanted to remove it. Bayer product Code above expiration date states 0C09C and expiration is Mar2023. Thumb pink: thumb nail to finger print past where you bend it was where she noticed it was pink. States it is now 98% better. Friday 26Feb2021 afternoon at 1 pm, right thumb turned pink. She took a pen and marked where it was vertical and horizontally pink to scarlet in color. She put herself on antibiotics. She was not sure if maybe she cutting chicken and cut it, or closed finger in drawer. It swelled up twice the size, turned purple. Went all around the finger and it was hot. She thought it was going to pop off. She kept wondering what she was going to do to her thumb. She did jam it and cut herself 2 months ago. Clarifies it was right hand thumb. Treatment: took antibiotics, which she states they kept her on in the hospital in IV form. She started the antibiotics on Friday 26Feb2021. Took it Friday afternoon, Friday night, and Saturday and Sunday. She thought it was doing better Sunday night before she passed out. Clarifies Cephalexin, 500 mg daily (Keppra) three times a day and by mouth. Adds that she keeps this medication on her because she travels the world and it is good to have on hand since it is broad-spectrum. Passing out: 28Feb2021 Sunday night noticed the volume on television was driving her crazy and it was irritating. Around a quarter to 9 she got up to brush her teeth and go to the bathroom. She went pee and then fell off toilet. She got really really dizzy, and her husband was standing over her yelling asking what happened. She saw the wall and she did not know what happened. States she was out cold and he was calling her name but she did not hear him. She heard him asking what happened but it was in the distance. He got her to bed and about 20 minutes later (husband reports 30 minutes later) she was so dizzy and passed out again. She adds that this may have happened Saturday also because she was sleeping a lot and it was like she was seeing words repeat themselves over and over again and her vision would get very narrow. Her husband was note sure if she passed out on Saturday also, but said both times Sunday she was out cold. Monday 01Mar2021 she called her husband's office and woke up to the nurse on the other line screaming. She dropped the phone and heard her name being screamed over and over on the phone and when she picked it up the nurse said that she must have passed out even though she thought she was sleeping. The nurse got ahold of her husband in his office. She believes she passed out again Monday morning and was then in the hospital Monday and Tuesday. Hospitalization: On 01Mar2021, her husband is a physician and suggested she go to the hospital. She was trying to get ahold of her son and daughter in law. She sent them a text and called and they did not answer. Her sons phone was charging and when he looked at it he was on his way to her. She states that when she came to all three times, she was extremely dizzy foggy and confused. Adds that the nurse at her husband's office alerted her husband and he told her to stay in bed and her son came to help her and then drove her to ER. States she was there Monday 01Mar2021, and discharged Tuesday night 02Mar2021 about 4:30 to 6 pm. Caller does not want to file a report for her husband regarding the injection site soreness. She states it was like the flu shot. She clarifies that it was not his arm, it was the injection side. She states that these people who are going on and on about their arm hurting, it is the injection site. She states it is the injection site and will not be the arm. States that it is like the flu shot. States she does not want to file a report regarding her husband because it was injection site soreness and went away. Provides no additional information. Adds that this is a new drug and new disease and we do not know what the future holds Caller adds that she keeps a diary and started a diary so that she has everything recorded in terms of medical history. States that it is important that everybody do so. Family Medical History Relevant to AE(s): callers dad passed out at age 85. He found out he was diabetic and had heart issues. Also had a stroke at age 87 and passed away. Adds that between ages 85 and 87 he passed out every few months, he would do one of his passing out things. Caller also had a brother who passed out sitting at table and went forward into table. She states at that time her brother didn't realize he had stage 4 lung cancer, and her brother passed away 1 and a half years later. Caller adds that he smoked from ages 15 to 64, and quit at age 63 because the doctor told him to. No follow-up attempts possible. No further information expected.
67 2021-03-30 hypertension pt states she started feeling very bad and everything hurt the day after getting the vax. She has a... Read more
pt states she started feeling very bad and everything hurt the day after getting the vax. She has a lot of hair loss. She had to stay in the bed for the next couple of days because she had fatigue and body aches. 5 weeks after taking the vax she has swollen lymph nodes in both arm pits and he developed sore knots under the skin on the outside of her thighs. Her BP has become uncontrollable. She was on 10mg of bp medicine and then it was upped to 20 mg. About 7 days ago a diuretic and her BP is still very high. on 3/20/2021 it was 180/89. she checked it again a couple of hours later and it was 165/92. She has had symptoms of GERD since 3/22/2021. Blood work she had on 3/18/21 shows way too much carbon monoxide in her CO2. Her anxiety has increased since she was vaccinated. She has an appt w/ her PCP on 4/9/21. She is very concerned that she is going to die from taking this vax.
67 2021-03-31 palpitations, heart rate irregular anaphylactic reaction; Throat swelling; heart racing; irregular heart rate; gasping for air; This is... Read more
anaphylactic reaction; Throat swelling; heart racing; irregular heart rate; gasping for air; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration in Right buttocks, at the age of 67-year-old, on 08Mar2021 10:00 as SINGLE DOSE, for covid-19 immunisation. Medical history allergies: Sulfites, urinary tract disorder, Birth defect bladder w/ recurrent kidney stones, kidney infection, Grave's disease, and lyme disease. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination and was not tested post vaccination. Concomitant medications included levothyroxine and epinephrine. The patient previously took sulfur dioxide and experienced drug hypersensitivity. The patient experienced anaphylactic reaction with throat swelling, heart racing, irregular heart rate, gasping for air on 08Mar2021 10:45. Therapeutic measures taken in response to the events included self administration of epinephrine. The events were assessed as serious (life threatening). Outcome was recovering at the time of the report.
67 2021-04-12 heart attack My MOTHER had a health condition, diabetes and heart problems, she was at home with palliative care,... Read more
My MOTHER had a health condition, diabetes and heart problems, she was at home with palliative care, due to her condition, she was fine in the last month she was able to walk, shower, eat alone, she felt happy to be able to recover, she got the vaccine because the doctor advised her, the same day she got fever, and began to feel fatigued, 3 days later my mother died, she had heart attack from shortness of breath.
67 2021-04-12 cerebrovascular accident problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's ... Read more
problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; dragging her feet; trouble standing up; feels like a stroke in her leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), intramuscular, administered in the left arm on 24Mar2021 at 12:30 as a single dose for COVID-19 immunization. Medical history included stroke on Dec2015 and Feb2016 and ongoing left side, having weakness since she had a stroke. The patient's mother had a really bad stroke on an unspecified date in her 80's. The patient's concomitant medications were not reported. The patient previously received the first dose of BNt162B2 (lot number: EN6208) on 03Mar2021 for COVID-19 immunization and had a sore right arm. It was reported that on 26Mar2021, the patient was dragging her feet and having trouble standing up. This occurred after her second shot. She has had a problem with her left side, having weakness since she had a stroke at the age 62 years. She worked through it and it was fine. But when she took the 2nd shot, it's been bothering her through the weekend. Her left side weakness worsened. She described the feeling like the stroke. Her doctor said when she gets sick, it could mimic her stroke symptoms. She added it is worse in the morning when she tries to get up. The patient added that her leg is affected, and feels like a stroke in her leg on Mar2021. She had no treatment for her experience and doesn't know if there is a treatment for what she is experiencing. The outcome of the events was unknown. Information on the lot/batch number has been requested.
67 2021-04-13 chest pain Patient presented to ED with difficulty walking, falls, right sided chest pain, lower extremity edem... Read more
Patient presented to ED with difficulty walking, falls, right sided chest pain, lower extremity edema, generally felling unwell
67 2021-04-16 blood pressure increased, cerebrovascular accident, haemoglobin decreased entered room drooling . right sided neglect BP elevated . not following command send to ER A... Read more
entered room drooling . right sided neglect BP elevated . not following command send to ER Admited to hospital with CVA PCP Note upon return - Patient is a 67-year-old female with past medical history of hypertension, MS, dementia, CHF, chronic kidney disease and hyperlipidemia who was sent from the facility to the emergency room for altered mental status and possible CVA. In the emergency room, blood pressure was elevated at 170/100 and she was noted with more pronounced weakness in left upper extremity and lower extremity and left gaze. Neurosurgery was consulted and deemed patient a poor candidate for TPA due to recent GI bleed. Stroke workup was negative for acute findings and a brain MRI ×2 was negative. EEG was ordered to rule out seizure and it was normal and neurologist recommended to start patient on Keppra. Patient was initially started on aspirin which was stopped due to drop in H&H. Patient was also noted with low-grade fever and infectious workup including blood cultures, UA and extensive imaging did not have evidence of infection and COVID-19 was negative. Social services spoke to patient's sister who is the POA regarding advanced directives and she requested to change advanced directives to DNR/DNI/no PEG and orders noted in chart. Patient's symptoms progressively improved and discharged back to the facility and resting in bed comfortably in no acute distress
67 2021-04-17 fainting Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell... Read more
Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; busted her lip and it was bleeding real bad; Weakness/ feeling weak; Feel weak in her arms and legs; Sweating profusely; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Foggy Brain; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) intramuscularly, administered in the left arm on 11Mar2021 (batch/lot number: EN6205) at 67 years old as a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Pharmacy/ drugstore. The patient's medical history included compromised immune status; respiratory illness, genetic /chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; asthma diagnosed since childhood; diagnosed allergies, allergies (seasonal and food); food allergies included gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, broccoli, cauliflower, cabbage, brussel sprouts, asparagus, all "percifirous"/ cruciferous vegetables; she also has allergies to cats, pollen, trees, grass, ragweed, mold, mildew, and dust; and allergies to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, and Clindamycin (patient does not have a manufacturer, lot or expiration to any of these medications). The patient had no family medical history. Concomitant medications included unspecified prescription medications for years which she did not feel they were relevant. On 11Mar2021, the patient experienced "weakness/ feeling weak" (weakness), "feel weak in her arms and legs" (weakness of limbs), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (faint), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (fall), "busted her lip and it was bleeding real bad" (bleeding lips), sweating profusely (excess sweating), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Flu-like symptoms), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Joint pain), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (muscle pain), and foggy brain (foggy feeling in head). On 12Mar2021, the patient experienced headaches, chills, itching rash on arms, back, neck and chest (itchy rash). On13Mar2021, the patient experienced blurred vision. It was reported that after the first shot, on 11Mar2021, patient experienced weakness, then she got home and she fainted, fell, and busted her lip and it was bleeding real bad. Then she began sweating profusely. She started feeling weak 30 minutes after getting the shot. Someone took her there because she would not have been able to drive. They brought her home and she was in the kitchen. While over the sink, she started to feel weak in her arms and legs. Before she could tell her husband that she was feeling weak, she dropped to the floor and everything was turning black. She fell face first and busted her lip and it was bleeding real bad. The weakness gradually started getting a little better on 30Mar2021. She is having to walk with a cane now because of the weakness. She was not using a cane before. Two days later on 13Mar2021, she was in the kitchen again and she felt that feeling coming and her husband was able to grab her and sit her down and she did not faint but she could tell it was coming. Patient also reported that from 12Mar2021, she is getting headaches every day off and on and in different spots of the head. Sometimes it is in the forehead, top, side and back. For about a good week, she had chills and it tapered off after the first dose. Also, on 12Mar2021, she experienced itching rash on arms, back, neck and chest. They were fine bumps and they just itch. The patient was recovering from the events faint, fall, bleeding lips, excess sweating, and itchy rash; and has not recovered from the events weakness, weakness of limbs, flu-like symptoms, joint pain, muscle pain, foggy feeling in head, headache, chills, and blurred vision. Follow-up attempts are completed. No further information is expected.
67 2021-04-17 hypertension Chronic obstructive pulmonary disease exacerbation; hypertension; vaccination complication; really s... Read more
Chronic obstructive pulmonary disease exacerbation; hypertension; vaccination complication; really sick; nausea; headache; The patient had decreased breaths from 12 to 10 breaths; This is a solicited report received from pharmacy. A contactable other healthcare professional and a consumer (patient) reported that a 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunization; treprostinil sodium (TYVASO, concentration of 0.6 mg/ml), resp inhalation (reported as via inhalation (IH) route) from 23Sep2020 (batch/lot number: 2101929; expiration date: 31Jan2022) to an unspecified date, delivered by Tyvaso inhalation device (TD-300/A) at 18-54 ug, QID (3-9 breaths), then via an unspecified route of administration from an unspecified date (batch/lot number was not reported) to an unspecified date, at 72 ug to 60 ug (12 to 10 breaths) for secondary pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension and ongoing chronic obstructive pulmonary disease. Concomitant medication included tadalafil taken for an unspecified indication, start and stop date were not reported. On 25Mar2021, the patient experienced events of chronic obstructive pulmonary disease exacerbation (chronic obstructive pulmonary disease, hospitalized), hypertension (hypertension, hospitalized) and reaction to COVID vaccine (vaccination complication, hospitalized). On an unreported date, the patient experienced events of really sick (illness), nausea (nausea) and headache (headache). On an unreported date, the patient had decreased breaths from 12 to 10 breaths (off label use). It was also reported that the patient had decreased breaths from 72 ug to 60 ug (12 to 10 breaths). The patient was really sick, nausea and headache. On 25Mar2021, 6 months and 3 days after initiating IH Tyvaso, the patient was hospitalized for reaction to coronavirus disease (COVID) vaccine, chronic obstructive pulmonary disease exacerbation, and hypertension. The patient was discharged from the hospital on 28Mar2021. The action taken in response to the events chronic obstructive pulmonary disease, hypertension and vaccination complication for treprostinil sodium was not reported, and dose was decreased due to the events illness, nausea and headache. At the time of reporting, the outcome of chronic obstructive pulmonary disease, hypertension, vaccination complication, illness, nausea and headache was unknown. The reporter did not provide causality for the events of chronic obstructive pulmonary disease, hypertension, and vaccination complication. The reporter's causality for the events illness, nausea and headache with IH treprostinil sodium was considered to be possibly related. Case Comment/Sender's Comment: The company has assessed the serious adverse event of chronic obstructive pulmonary disease, hypertension and vaccination complication as not related to IH treprostinil and TD-300/A device. Chronic obstructive pulmonary disease and hypertension were likely due to exacerbation of underlying COPD and Hypertension respectively. Vaccination complication was due to COVID vaccine. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is based on the company causality assessment. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event chronic obstructive pulmonary disease, hypertension, vaccination complication, illness, headache, nausea and the suspect drug BNT162B2 , TYVASO cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
67 2021-04-17 cardiac arrest, low blood oxigenation Hypoxia; cardiac arrest; This is a spontaneous report from a contactable physician. A 67-year-old fe... Read more
Hypoxia; cardiac arrest; This is a spontaneous report from a contactable physician. A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via intramuscular route of administration on 03Apr2021 at 15:15 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Mar2021 (at the age of 67 years) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 05Apr2021, the patient experienced hypoxia and subsequent cardiac arrest. The events resulted in Emergency room/department or urgent care and hospitalization. The events were considered life threatening. Therapeutic measures were taken as a result of the events which included CPR and intubation. It was unknown if patient has been tested for COVID-19. The outcome of the events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events hypoxia and cardiac arrest cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-04-17 blood clot I had emergency surgery to remove a femoral blood clot from my groin to the bottom of my left leg; T... Read more
I had emergency surgery to remove a femoral blood clot from my groin to the bottom of my left leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Mar2021 12:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation at a Pharmacy or Drug Store. Medical history included known allergies to sulfa drugs, latex, animal dander, dairy, wheat, mold, mildew, ragweed and other wildflowers; and clot once before in the same leg-left inner thigh in 1974. Concomitant medications included thyroid (ARMOUR THYROID) and apixaban (ELIQUIS). The patient previously had a pneumonia vaccine on 24Feb2021 in the left arm. The patient does not know if her first dose of Pfizer vaccine caused this, but on "04Mar2010" (as reported) she had an emergency surgery to remove a femoral blood clot from her groin to the bottom of her left leg which started on 03Apr2021 at 12 AM (as reported). The event resulted in emergency room/department or urgent care visit, hospitalization for 2 days and was considered life threatening illness (immediate risk of death from the event). She had a clot once before in the same leg-left inner thigh in 1974. The patient was on Eliquis 5 mg 2 pills 2 X day for two more days, then 1 pill in am and 1 pill in evening for rest of her life. The patient had the second dose of BNT162B2 (lot: ER8732) on 07Apr2021 in the left arm. The patient has no covid prior vaccination and was not tested for covid post vaccination. The event recovered with lasting effects.
67 2021-04-17 blood clot, cerebrovascular accident Stroke due to a large blood clot to the brain; Stroke due to a large blood clot to the brain; Widesp... Read more
Stroke due to a large blood clot to the brain; Stroke due to a large blood clot to the brain; Widespread blood clots in both of her arms; This is a spontaneous report from a contactable consumer (daughter). A 67-year-old female patient received the 2nd single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in the left arm, on 17Mar2021 (at the age of 67 years old, not pregnant at time of vaccination) (Lot number was unavailable since unable to locate or read the details), for COVID-19 immunisation. The patient's medical history included ongoing atrial fibrillation, high blood pressure, and scoliosis. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN) for atrial fibrillation, naproxen, pregabalin, tramadol, and metoprolol. The patient never had a history of blood clots. There were no allergies to report. The patient had not received any other vaccines in the four weeks prior to receiving BNT162b2. The patient had received the first single dose of BNT162b2 on an unspecified date, in the left arm. The patient's daughter stated that her mother suffered a stroke due to a large blood clot to the brain on 25Mar2021 at 12:30 am, requiring hospitalization. During hospitalization, a surgery to remove blood clot from the brain was needed. Hospitalzation lasted 12 days. The reporter added that in the week prior to the reporting, the mother 'passed' (as reported) but had widespread blood clots in both of her arms. The patient required unspecified treatment due to the events and had not recovered at the time of the reporting. The events were considered also serious since life threatening and due to disability. The patient did not have COVID-19 prior to the vaccination and had not tested positive post vaccination. Information on lot/batch number has been requested.
67 2021-04-17 fainting, very slow heart rate bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; sec... Read more
bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; second dose received on 15Mar2021; first dose received on 09Mar2021; second dose received on 15Mar2021; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 15Mar2021 15:00, as single dose, for COVID-19 immunisation. Medical history included psoriasis, high blood pressure, scoliosis and low thyroid. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline; sertraline hydrochloride (ZOLOFT); and levothyroxine sodium (LEVOTHYROXINE), all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) received at age 67 years, via an unspecified route of administration in the right arm, on 09Mar2021 14:45, for COVID-19 immunisation. On 15Mar2021, the patient experienced bradycardia, was fainting, and had head and neck ache. One week after the second vaccine, in Mar2021, the patient was taken to the hospital due to the events. Treatment for the events included "had to have a pacemaker put in". The patient reported that she never had heart problems before, and she was curious if these could have ben side effects from the vaccine. The events resulted to physician office and emergency room visits, and hospitalization. The duration of the hospitalization was reported as 4 days. The events were reported as life-threatening illnesses. The patient was recovering from the events. Information about Batch/Lot number has been requested.
67 2021-04-17 heart attack heart attack; stopped breathing; This is a spontaneous report from a contactable consumer. A 67-year... Read more
heart attack; stopped breathing; This is a spontaneous report from a contactable consumer. A 67-year-old female patient (mother) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Mar2021 (67-year-old) as single dose for COVID-19 immunization. Medical history included Hypothyroid, Sleep Apnea, Known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Patient is not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); apixaban (ELIQUIS); senna [senna alexandrina]; valsartan; clopidogrel; metoprolol; atorvastatin; macrogol 3350 (MIRALAX). The patient previously took vitamins, Claritin , first dose of bnt162b2 on 24Jan2021 01:00 PM (67-year-old) for COVID-19 immunization and exactly 3 weeks after the first dose, the patient had a heart attack and stroke. Exactly 3 weeks after the second dose (04Apr2021), the patient stopped breathing and died. It was reported that death cause was unknown but also likely heart attack (unspecified date). Ae resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died]. Number of days hospitalization is 10. Patient had no covid prior vaccination. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included covid test (Nasal Swab): negative on an unspecified date. The patient died on 04Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: stopped breathing; death cause: likely heart attack
67 2021-04-17 cerebrovascular accident, heart attack heart attack; stroke; This is a spontaneous report from a contactable consumer. A 67-year-old female... Read more
heart attack; stroke; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 24Jan2021 13:00 (at the age of 67-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroid, sleep apnea, known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); clarithromycin (CLARITIN [CLARITHROMYCIN]). In Feb2021, Exactly 3 weeks after the first dose, the patient had a heart attack and stroke. The events were assessed as serious (hospitalized, life-threatening, disability). The event resulted in emergency room and physician visit.The patient was hospitalized for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown. Information about lot/batch number has been requested.
67 2021-04-18 hypotension, cerebrovascular accident, troponin increased Patient admitted 4/17 after covid vaccination on 4/16. Was found to have elevated troponin on admiss... Read more
Patient admitted 4/17 after covid vaccination on 4/16. Was found to have elevated troponin on admission, hypokalemia, septic, elevated ALT, and hypotensive. Patient believed to have stroke on 4/19 and required intubation and transfer to ICU.
67 2021-04-19 hypotension Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiog... Read more
Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiogenic shock, progressed to multi organ dysfunction.
67 2021-04-24 chest discomfort Losing voice, like Laryngitis; Chest was heavy; Red spots on arm; Losing voice, like Laryngitis; Har... Read more
Losing voice, like Laryngitis; Chest was heavy; Red spots on arm; Losing voice, like Laryngitis; Hard to swallow; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left, 2 inches below shoulder on 31Mar2021 14:45 at the age of 67-years-old (Lot Number: EP7533) as single dose for covid-19 immunisation. The patient medical history included Covid in January in an unspecified year and underlying health issues. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient had adverse reactions to some medications, she did not know the names of the medications. On 31Mar2021, the patient experienced hard to swallow after she had the shot about 15 minutes at 3 p.m.; losing voice 20 minutes after the shot, chest was heavy and red spots on arm about 20 minutes after the shot. The patient stated she went to the emergency room where the doctor gave her 50mg of diphenhydramine hydrochloride and she tought some type of stomach pill. The patient stated she fell asleep for an hour and when she woke up, her chest was not heavy and she could swallow better, reclarifies that, her voice, felt like she had some laryngitis. The patient stated she had an appointment on 28Apr2021. The patient stated that she talked to the provider about taking the second vaccine, and her doctor told her to take the diphenhydramine hydrochloride before the she got the vaccine. She would have had the second vaccine by the time of her next appointment. The events outcome was recovered on 31Mar2021. No follow-up attempts are needed. No further information is expected.
67 2021-04-24 heart rate increased Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; inject... Read more
Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; injection site redness; severe allergic reactions; slight dizziness; severe headache; nausea; weak; tired; feverish; sweat; had pain at the Pfizer Covid 19 Vaccine injection site; right arm started to swell; chills; extreme muscle pain; certainly extreme and joint pain; Heart beat seemed to speed up; Has not been able to walk or move body in normal fashion; This is a spontaneous report from a contactable consumer (patient herself) A 67-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) a week ago via an unspecified route of administration on 02Apr2021 at 13:45 hrs on the right upper arm as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.When caller was 18 they required a booster for Small pox and caller received the small pox booster on the leg in the same site where it was given at age 5. Caller's leg swelled up to 5 times the normal size, at the time caller was 18 years old.Took a long time for swelling to go away, a couple weeks. Caller requires it hindered sports activities during this time. On 02Apr2021, the patient started reported slight dizziness, severe headache, Shakiness, nausea, weakness, tiredness, have been feverish, pain at the injection site and stated that her right arm started to swell. The patient stated that through out the night of 02Apr2021, she had extreme muscle pain, certainly extreme and joint pain that was also extreme and heart beat seemed to speed up within the first hour and by the end of the hour. On 03Apr2021, the patient stated that her muscles and nerves seemed to be locking up like almost paralyzed. The patient described the events she experienced slight dizziness and didn't worry because it wasn't major and caller was driving herself and with in an hour the dizziness got worse. Caller had severe headache and had to drive home a significant distance and the time the caller got home, she reports being shaky, dizzy, had headache, nausea, was weak and tired and must have been feverish. Caller reports she must have been feverish because she was drenched in sweat by the time she got home and it was a 2 hour drive home from the vaccine administering facility. Caller had pain at the Pfizer Covid 19 Vaccine injection site, and caller's right arm started to swell.Caller clarified that the injection site was in the right upper arm, doesn't know what the muscle is called. Caller says she couldn't see if her arm was getting red, caller has some discs out in her neck and is unable to look at the arm. Caller could feel the injection site on her right arm was swollen and swelling. Caller reports fever was gone and fever got replaced with chills later on. Caller reports there was progression of the symptoms after the first hour. Caller states the information provided thus far was the first hour of her experience and through the night a lot of other things changed and added.Through the night caller had extreme muscle pain, certainly extreme and joint pain that was also extreme. Muscles and nerves seemed to be locking up like almost paralyzed: By the next morning, after caller had the Pfizer Covid 19 Vaccination, states she was not a doctor but all of her muscles and nerves seemed to be locking up like caller was almost paralyzed. Caller reports she couldn't move, couldn't get out of bed. It took a long time to get caller's fingers and toes moving and the rest of the body, but fingers and toes were the first ones. Caller was able to kind of release from muscle cramping. Whatever was going on, caller says can't tell exactly what was going on, does not have a Doctor in the home. States the information given should cover that part of the experience. Through the night had extreme muscle pain, certainly extreme and joint pain that was also extreme: Reports since the morning after receiving the Pfizer Covid 19 Vaccine, caller has had continued muscle pain, although not as extreme, its pretty extreme, and join pain. The patient has not been able to walk or move body in normal fashion. The patient stated that she had every side effect listed on the fact sheet at the top minus the swollen lymph nodes and injection site redness and she had two of the side effects listed under the severe allergic reactions. The patient wanted to know whether it is safe to receive the second dose of the vaccine. The patient lives in an isolated area where all through COVID-19 she tried to get information from the local medical clinics and they did not seem to stay informed. Caller states she has a doctor's appointment, and she will let them know the side effects she experienced after the first dose but she is not confident in the recommendations they might provide. Patient was given a list of side effects to look for, ones they were assuming, doesn't know if the hand out was published by Pfizer or not.The hand out listed emergency kind of side effects people were experiencing.Caller reports they are over age 65 range and knew a lot of people before her who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Caller was expecting the same reaction, caller was told by the Doctor she was in pretty good shape. Caller reports she had most all of the reactions except anaphylactic reaction of not breathing after receiving first dose Pfizer Covid 19 Vaccine. Caller is nervous about going for the second round of the Pfizer Covid Vaccine, is not sure how to proceed and would like that information. The case was assessed as serious medically significant for the event paralysis. It was reported that patient took Aspirin as treatment medication for pain. The outcome of the events was resolved for fever and nausea, resolving for swelling arm, unknown for swollen lymph nodes, Chills , Vaccination site pain, injection site redness, severe allergic reactions, sweat, shaky feelings, heartbeat increased, movement disorder and not resolved for all other events.
67 2021-04-24 blood clot blood clot; Right leg swelled and achy; Right leg swelled and achy; This is a spontaneous report fro... Read more
blood clot; Right leg swelled and achy; Right leg swelled and achy; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534),dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included ongoing Beta thalassemias. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated she has never had a problem with vaccinations, and she gets the flu vaccine every year. The patient reported that after the first injection coincidentally she did develop a blood clot in her lower leg. She thinks that it was due to a plane ride, but she has never had a blood clot before the injection. She added that she had the first dose on 16Mar2021 and developed a clot in a week. She further clarified that she got her first injection on 16Mar2021 and realized when she went on a flight, which is not that far she developed that clot and was having problems shortly after flight home on 24Mar2021 where her leg swelled up and she is on blood thinners since she went to the emergency room. She added that she developed the clot sometime between that flight and 02Apr2021. She had a doppler study on an unspecified date and it showed a blood clot. She stated that the outcome was she does not have the blood clot (as reported) but she will be on blood thinners and she needs to follow up on her scan to see if the clot issue is resolved but she will not have a doppler scan for another month or two and the blood thinner she is taking is Xarelto. She also stated that her right leg swelled up and it felt like a log. She reported it felt achy and swollen quite a bit from knee down and her leg was achy. It started between 24Mar2021 and by time she went to the emergency room she was not getting better. She had her symptoms for a week and toward the end of the week she thought she had a blood clot since it was not getting better it just got worse. She added that right now it is not swollen but she has been supine, and she does believe that it is better. The outcome of events was recovering. (As reported "outcome is unknown but pretty sure it has improved because of the blood thinners"./She stated she does not think it has resolved because it takes time for clots to resolve./She added that right now it is not swollen but she has been supine, and she does believe that it is better.) The reporter stated for the seriousness criteria for event blood clot: she believes as a nurse that any blood clot is extremely dangerous, and she was not hospitalized but obviously a blood clot is serious, and she could have ended up with pulmonary embolism. The seriousness for events right leg swelled and achy was reported as medically disabling. Causality assessment: Patient stated for the blood clot she has doubts if it was related to the vaccine but is it something that should be known about; for the leg swelling and achy she has doubts but it could have been the plane ride.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is unlikely related to the suspected drug. The plane ride may provide an explanation for the events. The case will be reassessed if additional information becomes available.
67 2021-04-24 chest pain chest pains; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old f... Read more
chest pains; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old female patient received the second dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL9263), via an unspecified route of administration in the left arm on 14Feb2021 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included piroxicam (PAXIL). The patient was not pregnant at the time of vaccination. The patient had not had COVID-19 prior to vaccination. The patient had no known allergies. The patient previously received the first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 24Jan2021 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunization. On 14Feb2021 22:00, after the second vaccine, the patient began having chest pains, which she had never experienced before. The pain has lasted, and she was now being checked by a cardiologist. Treatment was received for the event. The patient had a chest X-ray and EKG on an unspecified date. The outcome of the event was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information about lot number has been requested.
67 2021-04-24 palpitations cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in swe... Read more
cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in sweats; She is still cold/She is freezing cold; She is loosing her hair. clumps of hair falling out.; sinus headache; had issues with her thyroid; sinusitis like when she had COVID; palpitation; nausea; feeling achy like you have a flu/ aches and pain; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in arm left on 26Mar2021 15:00 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included atrial fibrillation on an unknown date. Caller added she takes medication for Atrial Fibrillation. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache since she was diagnosed with Covid. Caller had a funny sensation in her sinuses after the injection. It was a weird feeling, just like when she had Covid. She had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. She had a lot of allergies. The patient's concomitant medications were not reported. The patient experienced headache on 26Mar2021 with outcome of recovered with sequelae on 27Mar2021, achy, chills, fever, nausea on 27Mar2021 with outcome of recovered with sequelae on 29Mar2021, palpitation, sinusitis like when she had covid, cramps, stiff neck, couldn't move her neck, it was very painful, she was breaking out in sweats, still cold/ freezing cold, loosing her hair/ clumps of hair falling out, sinus headache and had issues with her thyroid on an unspecified date with outcome of unknown. The clinical course reported as follows: Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 26Mar2021 and scheduled to get the 2nd dose on 16Apr2021. Patient experienced headache, sinusitis like when she had COVID, nausea, feeling achy like you have a flu, fever chills, cramps ,aches and pain, palpitation. Patient had tested positive for COVID last 28Dec2020 that lasted for 6 weeks. Asking if 2nd dose will be more intense when it comes to reactions and if she can safely have the 2nd dose. She will see her cardiologist due to chest palpitations. She worked and had her first Pfizer Covid-19 vaccine 26Mar2021. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache on Friday immediately after her injection. Then was okay. On Saturday morning after waking up, she felt achy, nauseous, had a fever, chills, and a headache. On Sunday she was not feeling great. Even into Monday, she had fever and chills and felt the same as when she had Covid. Caller added she is not supposed to get sick. Caller states weighs 160 pounds, which she shouldn't be. After the shot she felt a sinus headache. Funny sensation in her sinus's just like it was when she had COVID. Once she had the shot, the original headache went away along with her stiff neck. She couldn't move her neck, it was very painful, it still happens. And she had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. Caller had lasting effects from Covid, but didn't know if these symptoms were related to the shot. She was breaking out in sweats. She was still cold. There was something going on. She was having her Vitamin D level and thyroid checked. She was loosing her hair, clumps of hair falling out. She had issues with her thyroid. Caller wondering if the vaccine was the cause. She was freezing cold. She hadheart palpitations and was seeing her Cardiologist next Thursday. Caller received the vaccine because she had Covid and didn't want to get it again. She was pretty sick. She worked around people and didn't want to be in a situation because not everyone wants to get the vaccination. Treatment of events included: She had not been to the doctor for this, she just jumped into bed and took Tylenol. The events didn't require a visit to emergency room or physician office. No follow-up attempts are needed. No further information is expected.
67 2021-04-24 palpitations face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinu... Read more
face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinus infection; Shortness Of Breath; pounding in my chest/throbbing in her chest; ringing in ears; flared up some digestive issues / digestive disturbances; flared up some digestive issues / digestive disturbances; red on left side/face redness; exhausted all the time; This is spontaneous report received from contactable female consumer (patient) reported herself. A 67 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199) on 10Mar2021 17:30 at age of 67 years old at single dose in right upper arm for COVID-19 immunisation. Medical history included: last year February, she was really sick with bad sinus infection not knowing about COVID at the time. Sometime later she got these horrible digestive attacks, ended up in her stomach and esophagus, horrible attacks where she couldn't breath, she has had acid reflux in the past. digestive problems stayed with her a really long time, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. She tested in April last year, it was negative (not detectable). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No adverse events (AE) following prior vaccinations. Patient had first Pfizer covid vaccine on 10MAR2021, approximately 10 days to 14 days after the vaccine her face swelled up, numbness and red on left side, went to see my doctor, he treated her with steroid and antibiotic for sinus infection, at the same time she had some shortness of breath and pounding in my chest, and had and still have ringing in ears since then, it kind of flared up some digestive issues she had last year. If she back up to last year February, she had a bad sinus infection, went to see allergist, family doctor and ENT, all treated her for sinus' before covid testing was even a thing, they didn't think of covid testing at the time. It ended up in her stomach and esophagus, horrible attacks where she couldn't breath, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. In March2020 her husband came home with covid, after that, talking to his doctor, she brought him meals outside of the door, it occurred to her that queried if this could have been covid. She tested in April last year, it was negative (not detectable), they were still not sure if it could have been covid. She was supposed to get the second vaccine, she postponed it, the numbness and swelling of face is gone, next shot was tomorrow. Since this was a delayed reaction, typically one to three days would be a reaction to the vaccine. she didn't associate it with the vaccine, asked if it could have been from the vaccine. She wanted to make sure that she was safe to get the second one. Response: Spoke from EUA factsheet for Recipients and Caregivers: LAB-1451-4.0 Revised: 06 April 2021: Sections: who should not get the PFIZER-BIONTECH COVID-19 VACCINE and what the risks of the PFIZER-BIONTECH COVID-19 VACCINE were. Spoke from attached VR Consumer- Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BioNTech Covid 19 vaccine). Your doctor/healthcare provider is in the best position to assess and advise you as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. Patient calling about the COVID vaccine. She states that she had the first vaccine 10MAR2021, and 10 days afterwards her face swelled up. She had numbness in it and redness. She went to the doctor and the doctor thought that maybe it was a sinus infection. So she was treated for that. She states that she did have a few other symptoms. To make a long story short, she was suppose to have the last vaccine last Friday. She postponed it for a week (postponed getting the second shot for a week). She wants to know what Pfizer thinks about her getting her second vaccine and her side effects. She says that somewhere between the 10th and 14th day, after receiving the vaccine the symptoms started and that was why she did not think she had a reaction to the vaccine. She has not had anything like that before, it was sort of a delayed reaction. She states she is better now. She had a few symptoms after the face things started and the only thing that she still has now is ringing in her ears. She states it all started around the same time as her face issues, or might have started a little after that. She confirms everything but ringing in her ears have completely resolved. She states that she did have some digestive disturbances, shortness of breath, and throbbing in her chest after receiving the vaccine. She asks if she can go back a little bit to explain. She states that last FEB2020 she was really sick with bad sinus infection not knowing about COVID at the time. She went to her allergist, then her family doctor, and then an ENT. She states that it was nothing like she has ever had, it was really bad. Sometime later she got these horrible digestive attacks, she has had acid reflux in the past but it was nothing like this. In March her husband had COVID and tested positive for COVID. She decided to get tested and she tested negative. She wonders if she had COVID earlier but at that time they were not testing for COVID. Her digestive problems stayed with her a really long time, and she was still on the medications her gastrointestinal doctor put her on. They are hypersensitive esophageal medication. She states that she has been exhausted all the time. The rest of the story she has told already. She states that after the face thing happened she started getting those digestive issues again. Her friend suggested that she call Pfizer, so she is doing that. She confirms that the vaccine card does not have an expiration date, NDC, or dosing information. She states it says 0.3 ml, but she cant see a point, so she doesn't know if its just 03. She states she got the vaccine to lessen her chances of getting a severe disease, in case she ends up in the hospital. Also, to keep herself safe from other people. She states she wants the second one because husbands works with the public and she wants to be protected when he comes home. She states that she has those gastrointestinal disturbances and is on amitriptyline 10 mgs for that. She states she also takes something for her thyroid but she has no major health issues. She states that she had a endoscopy and a colonoscopy as well as blood work done but she doesn't have any of the results because they are in her Beaumont chart where she actually got the vaccine. All of this was pre-vaccine so she doesn't know how relevant it is. The patient did not require a visit to Emergency Room, but visit to Physician Office. The only thing similar had a sister who reacted to a shingles vaccine, She has no information about her sisters reaction to the vaccine. Outcome of event ringing in ears was not recovered, for others was recovered. No follow-up attempts are needed. No further information is expected.
67 2021-04-27 chest discomfort Nausea; Dizzy; Face Hot; Trouble breathing/chest tightness; Trouble breathing/chest tightness; 1hr p... Read more
Nausea; Dizzy; Face Hot; Trouble breathing/chest tightness; Trouble breathing/chest tightness; 1hr pain to shot; administered in right leg; This is a spontaneous report received from a contactable hcp (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right leg on 15Mar2021 09:30 (Batch/Lot Number: EN6204) as single dose for COVID-19 immunization. Medical history included known allergy, asthma, atrial fibrillation, urticaria. Concomitant medications included cetirizine hydrochloride (ZYRTEC) as pre treated; diphenhydramine hydrochloride (BENADRYL) as pre treated. The patient previously received the first dose of BNT162B2 (Batch/Lot number: EN6200) on 20Feb2021 13:00 in left leg by injection for COVID-19 immunization. The patient experienced nausea, dizzy, face hot, trouble breathing/chest tightness, pain to shot, all on 15Mar2021. Clinical course: Pre treated u/ 50mg Benadryl and 1 Zyrtec. 1hr pain to shot. u/in 15 minutes of shot: Nausea, dizzy, face hot, trouble breathing/chest tightness, given oxygen +2 more Benadryl laid down u/ feet up, discharged 1200HR Sx resolved by next day (24hours). The outcome of the events was recovered on 16Mar2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events nausea and vaccination site pain were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events "face hot, trouble breathing/chest tightness" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
67 2021-04-27 anaemia, hypotension multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past m... Read more
multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past medical history of hypertension and hypothyroidism. Status-post spinal decompression due to stenosis. The patient then developed worsening issues with a surgical site infection. Patient has had numerous bouts of C diff. Staff notes patient is to have GI consult in the near future. Patient is seen today in her room. Patient was once again diagnosed with C diff and is currently being treated with antibiotics. Patient notes no bowel movements today. Patient has not had any issues with intake recently. The patient's weight has declined partially due to likely diarrhea. Patient's blood pressure continues to be monitored closely as it has been on the lower side of normal. Patient's potassium 2.9 on CMP. Patient's other care and therapies were reviewed. 2/28/21 Patient was admitted the hospital after found to be anemic at skilled care facility where she is being treated for C diff infection recurrent Lea. Patient was transfused. Patient was also found to have pneumonia/lung mass. Patient has struggled with electrolyte dysfunction. Patient had to be transfused a second time. Patient did well with second transfusion. Patient was found to be hypokalemic. Patient did well with potassium replacement. The patient was advised will have to do outpatient PET scan. Patient was found to have positive blood cultures as well 4/26/21 68 y.o. female who presents from nursing home with complaints of elevated white blood cell count. According to nursing home records patient had CBC checked on Saturday 04/24/2021 and her WBC count was found to be 50,000. At that point in time no other orders were given and patient was not sent in for evaluation. CBC was repeated this morning and WBC count found to be in the 70,000s. Patient was sent in for evaluation this morning. In talking with the patient, she denies any runny nose, sinus drainage or cough. Patient does report shortness of breath. Patient denies any chest pain or palpitations. Patient denies any dysuria, hematuria, fevers, or chills. Patient denies any nausea or vomiting. Patient does report diffuse pain across the lower abdomen. She does report chronic diarrhea. Patient had C diff stool checked on 04/13/2021 and was negative. (4/26 cdiff positive) Of note patient does have known lung mass that was seen on chest x-ray and PET scan. Patient reports that she does not want anything done and understands it could be cancer. And continuing to question patient, she reports she wants to be a DNR and does not want any aggressive measures.
67 2021-04-28 fainting collapsed, head hit the tile floor of bathroom; collapsed, head hit the tile floor of bathroom; righ... Read more
collapsed, head hit the tile floor of bathroom; collapsed, head hit the tile floor of bathroom; right arm was bruised; corner of her eye was purple/bruised; feeling nauseated; Headaches off and on; pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6208) intramuscular, administered in Arm Left, at the age of 67-year-old, on 19Mar2021 11:00, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma and Allergies. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203) single dose, at the age of 67-year-old, on 26Feb2021, for covid-19 immunisation and experienced slight ache in her left arm, headaches, and mitral valve disease. On 20Mar2021, the patient had headaches off and on and the patient mostly woke up with them. The patient doesn't know if the headaches were from pollen in the air since it is Spring time or mold. On 24Mar2021 at 4am, the patient got out of bed because she had to use the restroom. As soon as the patient took the first step into the tile floor of the bathroom, the patient collapsed. The patient didn't fall, the patient collapsed on the file floor. Her head hit the floor. Her head was killing her when she was laying there. The patient used the restroom and went back to bed. The patient got out of bed because her head was killing her. The patient guesses she threw her right arm out to brace herself, because she noticed her right arm was bruised the morning of 24Mar2021 when she went to shower. The patient took Equate 500MG for the events head hit the tile floor of bathroom, headache, and right arm was bruised and used a wash cloth with cold water as a cold compress and applied it by her eyebrow, the corner of her eye was purple/bruised. It looked like she had eyeshadow on. On 24Mar2021, she was feeling nauseated. Thankfully, she had the next 2 days off (Thursday and Friday) because she didn't feel so hot. On 26Mar2021, the patient called her PCP and was asked if she wanted to come in/ make an appointment. Since, the caller was planning to meet with the surgeon about her upcoming surgery on 29Mar2021, it didn't really fit into her schedule. She was undergoing all these tests, etc. It was determined her surgery was going to happen after receiving the second vaccine. The surgery is hopefully a mitral valve repair. The patient mentioned that her provider is aware of her experience with the COVID vaccine. The patient saw the surgeon on 29Mar2021, and she told him all about her experience. He advised the patient to call her PCP and schedule an appointment with them. She saw her PCP on 01Apr2021. She told her PCP what happened and her PCP asked why she didn't go to urgent care. The patient doesn't really know why she didn't, she just thought she was going to feel better. The patient thought she would work through the pain since Mar2021. Plus, she had everything going on with her surgery- like finding out she had to have the surgery and going under other tests. Her PCP wanted her to go to radiology to have a MRI of the head/brain done. She had the MRI done at 3:00PM on 06Apr2021 and the results were negative. Up until last weekend, she still felt "headachy". The patient has headaches too because of stress knowing her surgery was scheduled in a matter of 2 weeks, so she didn't know if the headaches she was experiencing was because of the COVID vaccine, stress, allergies, etc. The patient was certain the headache she experienced the day after she collapsed, was due to the collapse. The patient clarified that she knew it was more of a "collapse" instead of a fall because all the furniture leading to the bathroom, like the loveseat, lamp, cedar chest, etc, were all intact with no marks. It was like all of a sudden she collapsed. Her bruising is all gone, but there might be a slight mark that is like yellow and green (because the bruising changes colors) on her arm. Her eye was okay. The patient will have her planned surgery on 15Apr2021. The events required physician office visit. The patient underwent unspecified lab test and procedures relevant to her upcoming surgery but no other testing in regards to her symptoms after the COVID vaccine. Outcome of headache was not recovered, the events corner of her eye was purple/bruised and right arm was bruised recovered in 2021, while it was unknown for the other events.
67 2021-04-30 blood clot A little over a week after the First vaccination, I developed two blood clots in my leg; This is a s... Read more
A little over a week after the First vaccination, I developed two blood clots in my leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration, administered in the left arm on 18Mar2021 as SINGLE DOSE, for covid-19 immunization (at the age of 67 years-old). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration, administered in the left arm on 14Apr2021 as SINGLE DOSE. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included peripheral arterial occlusive disease from an unknown date and unknown if ongoing and bad circulation. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient developed two blood clots in her leg on 28Mar2021 a little over a week after the first vaccination. There was no treatment provided for the blood clots. The outcome of the blood clots was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
67 2021-04-30 excessive bleeding, chest discomfort bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc... Read more
bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
67 2021-05-03 transient ischaemic attack transient ischemic attack; This is a spontaneous report from a contactable consumer (patient). A 67-... Read more
transient ischemic attack; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration, administered in the left arm, on 30Jan2021 17:30, as single dose, for COVID-19 immunisation, at a hospital. Medical history included migraine and back pain. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included ketoconazole and hydrocortisone (HYDROCORTISONE), all taken for unspecified indications, start and stop dates were not reported. The patient previously took codeine and sulfur dioxide and experienced allergies to both. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on an unspecified date, for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. On 19Feb2021 at 11:00, the patient experienced transient ischemic attack. This resulted to emergency room visit and hospitalization on an unspecified date. The patient was hospitalized for 1 day. Treatment for the event included unspecified blood thinners. The patient underwent COVID nasal swab on 19Feb2021 which resulted to negative, and an unspecified test on an unknown date with unknown result. The outcome of the event was recovered with sequel (reported as recovered with lasting effects). No follow-up attempts are possible. No further information expected.
67 2021-05-04 excessive bleeding ulcerated ankles bled into her shoe/ bled more; ulcerated ankles bled into her shoe/ bled more; blee... Read more
ulcerated ankles bled into her shoe/ bled more; ulcerated ankles bled into her shoe/ bled more; bleeding disorder; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), first dose via an unspecified route of administration, administered in Arm Right on 01Apr2021 (at 67 years old), single dose for covid-19 immunisation. Medical history included ongoing ulcerated ankles, joint bleeding diagnosed prior to the vaccine in her 40s. The patient had no concomitant medications. On 04Apr2021, 3 days post-vaccination her ulcerated ankles bled. She explained this bleeding has happened before, but she bled more, and it reached into her shoes which is "unusual". Patient came home from shopping three days after the vaccine and her shoes were saturated with blood, states this lasted for about a day and resolved two days later around 06Apr2021. She was reading through the paperwork and it said to let them know if you have a bleeding disorder. She is scared. Her ankles have bled like this before, wants to know if this is considered a bleeding disorder, does the vaccine make you bleed more. The outcome of the events was recovered on 06Apr2021.
67 2021-05-06 fainting fainting; Severe head, neck and back pain; Severe head, neck and back pain; Severe head, neck and ba... Read more
fainting; Severe head, neck and back pain; Severe head, neck and back pain; Severe head, neck and back pain; nausea; vomiting; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route in the right arm on 19Apr2021 at 14:45 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included chronic severe tension headaches and allergies to some antibiotics (unspecified products). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. Concomitant medications included unspecified supplements and herbals. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) on 27Mar2021 at 14:45 in the right arm as a single dose for COVID-19 immunization. On 20Apr2021 at 02:30, the patient experienced severe head, neck and back pain, combined with nausea, vomiting and fainting. There was no treatment received for severe head, neck and back pain, combined with nausea, vomiting and fainting. The clinical outcomes of severe head, neck and back pain, nausea, vomiting and fainting was recovering. The patient was not tested for COVID post vaccination.
67 2021-05-06 cerebrovascular accident, heart rate increased, hypertension stroking; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; th... Read more
stroking; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW01B1/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 (at the age of 67 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension (HTN) and COVID-19 on an unspecified date. The patient had known allergies to ciprofloxacin (CIPRO), latex and iodine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Apr2021 at 12:00AM, the patient reported that after having her first vaccine on 19Apr2021, the next morning her blood pressure went up to 210/110 and HR 130 with a pounding headache and reported "thought I was stroking". The patient received treatment for these events which included extra medicine: an extra dose of losartan, clonopin and two acetaminophen (TYLENOL) and slept 24 hours. The outcome of the events blood pressure went up, heart rate increased, headache and "thought I was stroking" was recovering. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
67 2021-05-07 heart flutter, chest discomfort, palpitations cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appeti... Read more
cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appetite; Sleep pattern is bad/she cannot fall asleep until 0400 and then wakes right back up around 0800; Feels rough with fine bumps at times; Feels rough with fine bumps at times; Itches at times; Rash on outer aspect of arm; Tightness, uneasiness in chest; Palpitations, Fluttering in Chest; Palpitations, Fluttering in Chest; Easily Winded; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose on 16Mar2021 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), then the second dose on 07Apr2021 (Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), both via an unspecified route of administration, at the age of 67-years-old, administered in arm left as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from 2002 and ongoing, ongoing diabetes mellitus, penicillin allergy from an unknown date and unknown if ongoing, became really sick, really fast, uncertain if was Covid 19 from Feb2020 to an unknown date and chest discomfort from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), glyceryl trinitrate (NITROGLYCERIN), both taken for chest discomfort; dulaglutide (TRULICITY) taken for an unspecified indication, all from an unspecified start date and ongoing. The patient previously took morphine and codeine and experienced drug allergy. The patient was at her eye doctor on 02Apr2021 and decided afterwards to have her grandson take her to the Emergency Room (ER) for some tightening and uneasiness she had been having in her chest over the preceding days. She also felt some palpitations, they were fast, then slowed down; did not feel labored. She went to the ER and was there for 8 hours. They told her that her cardiac enzymes were extremely elevated. After the cardiologist reviewed her results she was allowed to go home. She went to her regular cardiologist on 05Apr2021. That cardiologist went over her tests results and said that while it was not normal results for her he didn't find them too worrisome. He stated that just because her enzymes are elevated does not mean she is in trouble. He scheduled her for a Dobutamine Stress Test on 07Apr2021. She has been trying to get the results of this stress test from the doctor's office but has not been successful in doing so. Says that once she completed the Stress Test on 07Apr2021 she went to get her second dose of the Covid Vaccine. She was still having her symptoms when she got her second vaccine and they have continued since. She saw her endocrinologist who went over blood work with her. The endocrinologist told her that her blood glucose level was very good and her A1c was a 5.5. The endocrinologist was concerned because usually the A1c is between 6 and 7. Patient was 5 foot 6- and one-half inches. Tightness, Uneasiness in chest: Stated it is not pain, just an uneasy, uncomfortable, fluttering feeling. Palpitations, Fluttering in chest: Not a labored feeling, goes fast, then slows down, not constant. Rash on outer aspect of arm: Extends from her wrist to about 2-3 inches below her elbow. Outside of arm, not on the inner part of her arm. Feels rough with fine bumps at times; then will feel smooth again. Itches at times. She uses calamine lotion, which does help to relieve the itching and smooth the skin. Stated it eventually does come back though. Easily Winded: She has had respiratory conditions all of her life. This winded feeling, she has been having is different than that she stated. She gets the fast heartbeat really quick, can almost hear it; becomes winded and sits down. The episodes last about 15 minutes. She has had no appetite; she has lost almost 15 pounds in 2 months. Her weight was 223 pounds 2 months ago and now weighs 211 pounds. She mentioned her sleep pattern is bad. Some days she cannot fall asleep until 0400 and then wakes right back up around 0800. The patient underwent lab tests and procedures which included blood glucose: 100 on 22Apr2021, blood pressure measurement: 128/62 on 21Apr2021, body temperature: 97 degrees fahrenheit on 21Apr2021, haemoglobin: 5.5 on Apr2021, heart rate: 78 on 21Apr2021, myocardial necrosis marker: extremely elevated on 02Apr2021, oxygen saturation: 98 % on 21Apr2021. Therapeutic measures were taken as a result of rash on outer aspect of arm, Feels rough with fine bumps at times and Itches at times. The outcome of the events Itches at times, Feels rough with fine bumps at times, Rash on outer aspect of arm, Easily Winded was not recovered; Palpitations, Fluttering in Chest and Tightness, uneasiness in chest was recovering, while of the rest was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
67 2021-05-13 loss of consciousness blacking out; seeing gray splotches; nauseous; light headed; I barely made it back to bed; This is a... Read more
blacking out; seeing gray splotches; nauseous; light headed; I barely made it back to bed; This is a spontaneous report received from a contactable consumer (reporting on herself). A 67-years-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP6955 and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 09Mar2021 10:15 as single dose for COVID-19 immunization. Medical history included hypertension, blood cholesterol increased, obesity , goitre , sciatica , arthritis, fibromyalgia, all from an unknown date and un-known if ongoing. Concomitant medication(s) included meloxicam (MELOXICAM); gabapentin (GABAPENTIN); levothyroxine (LEVOTHYROXINE); atorvastatin (ATORVASTATIN) all taken for an unspecified indication, start and stop date were not reported. The patient previously took ibuprofen, sulfa and synthroid and experienced drug hypersensitivity, First dose of BNT162B2 on 16Feb2021 09:15 for covid-19 immunisation The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that patient was up at 5:30 am and started seeing gray splotches and then she got nauseous and started blacking out. It happened again about 10 minutes later and she barely made it back to bed be-fore the whole thing stopped. When she woke up later she was still a little light headed. The out-come of the events was recovered on an unspecified date.
67 2021-05-13 blood clot left hand was edematous and cold; left hand was edematous and cold; left hand pain; blood clot; swol... Read more
left hand was edematous and cold; left hand was edematous and cold; left hand pain; blood clot; swollen submandibular gland that got bigger/could feel her mouth getting bigger; ill with something not related to the vaccine; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included stroke on 2007, COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX) taken for stroke from 2007 to an unspecified stop date; and acetylsalicylic acid (ASPIRIN (E.C.)) taken for stroke from 2007 to an unspecified stop date. The next day on 04Mar2021, the patient had a swollen submandibular gland that got bigger. She could feel her mouth getting bigger. The patient was admitted into the hospital on 07Mar2021 and released on 09Mar2021. She was readmitted to the hospital on 11Mar2021 until 18Mar2021. The patient went back into the hospital on 21Mar2021 and released 20Apr2021. The gland was removed on 13Apr2021. She developed a blood clot. She went to the emergency room and was sent home on Xarelto. The patient mentioned that she received the 1st dose of the vaccine on 03Mar2021 and came down ill with something not related to the vaccine. She was hospitalized for 4 weeks and ended up missing her 2nd dose appointment on 24/Mar/2021. She would like to get her 2nd dose but she is now 5 weeks overdue for it. She mentioned the hospital is recommending that she restart her vaccination. She is looking for guidance from Pfizer. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent had CT and MRI of left arm/wrist which she does not have results to provide. Event relatedness to vaccine was unknown for events, swollen submandibular gland that got bigger, left hand was edematous and cold, left hand pain and blood clot. The outcome of the event blood clot swollen submandibular gland was recovered with sequel on unspecified date, the outcome of ill feeling was unknown and the outcome of the rest of the events was recovering.; Sender's Comments: The 67-year-old female patient had medical history of stroke. Based on information available, the reported thrombosis and other events were unlikely related to the vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-01-07 chest discomfort 1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight he... Read more
1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness, shakes, overall malise, chest tightness. Later that day, mild diarrhea, mikd nausea. Day 3- woke with wheezing. Symptoms all continued for next 10 days off and on. The lip, tongue seemed to get shorter and shorter in duration. Also has mouth watering. Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec. Back to urge t care day 6, Ed day 8. Day 14 abd 15 awful chills, muscke ache and shaking.
68 2021-01-07 chest pain, troponin increased Patient experiencing Chest pain and elevated troponin. Patient taken to the cath lab and treated fo... Read more
Patient experiencing Chest pain and elevated troponin. Patient taken to the cath lab and treated for suspected stress induced cardiomyopathy.
68 2021-01-13 hypertension, palpitations Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metal... Read more
Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metallic-type taste and felt tingling around my mouth. I had been sitting in the post-vaccine observation area during this time looking at my telephone. I approached the nurse's desk and reported what I was experiencing and was taken to another room where I was put in a wheelchair and vital signs were taken. By now I think I became very anxious and fearful and my heart felt like it was pounding at 104. My BP went to 188/79 which is high for me and I felt SOB. I truly think the VS symptoms were related to anxiety, but I continued to have the taste in my mouth and my tongue felt like sandpaper. I was given 50 mg BENADRYL and observed for 30 minutes. After that amount of time, I felt better and safe to leave the hospital. Today, 1/14/2021, I have felt excessive tiredness and mentally dazed with diarrhea. No temperature, slight nausea this morning, and no vomiting. My left arm is only moderately sore. Now, at 7:30 pm I am feeling better and feel that I can work tomorrow. Honestly do not know if it was an adverse reaction or excessive anxiety. I do not have anxiety disorder.
68 2021-01-13 chest discomfort neck stiffness; coughing with production of white mucous; felt like she couldn't breath with tightne... Read more
neck stiffness; coughing with production of white mucous; felt like she couldn't breath with tightness for about a half hour; felt like she couldn't breath with tightness for about a half hour; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot /batch and expiration date unspecified), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the vaccine yesterday (07Jan2021) and that a couple of hours later she began to experience neck stiffness, coughing with production of white mucous and felt like she couldn't breath with tightness for about a half hour. The patient was asking if this was normal. Outcome of events was unknown. Information on the lot/batch number has been requested.
68 2021-01-18 chest pain Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , h... Read more
Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , headache joint pains , muscle pains , chest pains and nausea as well as Fatigue . I started taking Tylenol 500mg po q 6 hrs and that improve the sxs. The site of the injection was extremely red and swollen as well as lymphadenopathy underneath the left arm ( site of injection). The next day ( sunday) I noticed a swelling underneath the axilla going on top of the bra with blood exudate and looked as if I had bumped an object. The weakness continued during the next week and slowly the tiredness got better ( TOOK AT LEAST 7-10 DAYS).
68 2021-01-20 heart rate abnormal 3:18 sitting in general observation and c/o left side arm pain, radiating up neck. Describes pain as... Read more
3:18 sitting in general observation and c/o left side arm pain, radiating up neck. Describes pain as throbbing 5/10. Also c/o nausea. O2 97% on room air, HR 86; EMT on site in attendance. 3:24 BP 206/118 on Lt upper arm taken per EMT 3:30 BP 182/118; HR 118 per radial pulse. States pain now 2/10 is is a dull pain to a burning warm sensation. 3:35 O2 98% r/a, HR 68 3:40 BP 132/80 HR 66, O2 97% r/a. Patient states she is feeling better. Patient decided to go home accompanied by husband to private vehicle. EMT recommended to patient the she f/u with doctor is she feels worse. Ambulated with husband.
68 2021-01-21 chest pain Approximately 20 minutes after injection, - patient developed chest pain radiating to the neck - mi... Read more
Approximately 20 minutes after injection, - patient developed chest pain radiating to the neck - mild, dull pain (3 out 10 pain score) - weakness in both arms - shortness of breath PMHx - Had COVID-19 in July 2020
68 2021-01-21 chest discomfort Felt shaky, started to have facial swelling and tongue swelling and had to take diphenhydramine. St... Read more
Felt shaky, started to have facial swelling and tongue swelling and had to take diphenhydramine. Started to feel abdominal and chest tightness. Taken to ER and given IV diphenhydramine and IV dexamethasone
68 2021-01-21 chest discomfort I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightnes... Read more
I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightness. I say I was fine until 3-4 hours later, I had extreme headaches. At 430pm, I still had the headaches and I took Tylenol 500mg. At night my headache got worse and it felt like I had the flu. I then went to bed and when I woke up my left arm felt intense like hornets and it was swollen. I then took another Tylenol and Ibuprofen 600mg. At 4am, I felt awful and horrible. I had joint pain with aches, felt nauseated. I called my PCP and he told me to take Prednisone 10mg. My fever was 101.4F. By the night my fever was gradually coming down and it was 102F. By the next day I felt much better. I also had Covid-19 on March 2020 and also got tested for antibody test in July 2020. I spoke with my PCP and he is recommending I do not take the 2nd dose injection.
68 2021-01-22 chest discomfort 30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudde... Read more
30 minutes after the vaccine was administered, as I was walking in the parking lot, I all of a sudden felt weak, lightheaded, trembly, with chest tightness and a need to lay down. The biggest problem was that my eyes became strangely affected, like there were shutters being opened and closed in rhythmic waves inside my eyes. They were also very photosensitive and blurry. My whole head felt wrong. drove me home, (I could not have driven). This lasted several hours. I had chills and stayed laying down with my eyes closed. By the end of the day I felt mostly recovered. This series of events recurred 6 days later, on Jan. 20th. This time it also lasted most of the day, but I continued feeling moderately unwell the next day, and today it continues. I feel weak and unsteady. My eyes are better but not entirely. They ache and feel insecure. I am not currently feeling up to any activities besides resting.
68 2021-01-25 blood pressure decreased Mild headache within 1 hour of vaccine. Fatigue in evening necessitating early to bed. Slept thro... Read more
Mild headache within 1 hour of vaccine. Fatigue in evening necessitating early to bed. Slept through the night and awake in am without symptoms. Getting out of bed sudden drop in BP with weakness, feeling faint, nausea, sweating. Drop in BP to 68/52. Unable to go to work. Improved with upright resting in am with BP at 10:30 am 119/69 (low as my usual BP averages 130's/mid 80's). Still slightly nauseous. Able to have toast and tea. Felt better as am progressed and able to drive to work at 11:45 am. Worked until 6 pm without further symptoms.
68 2021-01-25 loss of consciousness Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vac... Read more
Patient self-reported through the hospital. In her own words, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21 @ 0630, at 2030 developed generalized aching, chills, weakness and sleepiness. Woke up at 0300, went to bathroom and passed out returning to bed. Awakened soaked in perspiration. Had dry heaves and 1 loose stool. Felt weak and sleepy until 0700, then felt mostly normal. Symptoms relieved by 1000. No other symptoms after that".
68 2021-01-26 chest pain Burning sensation in upper stomach, chest, throat. Rapid heartbeat
68 2021-01-26 heart rate increased, blood pressure increased Hot, red flush on face (particularly cheeks and forehead), slightly puffy, mild tingling in lips I w... Read more
Hot, red flush on face (particularly cheeks and forehead), slightly puffy, mild tingling in lips I was observed for an extra 20-30 minutes. Vital signs were taken. Blood pressure up slightly, heart rate slightly elevated Sent home without treatment but recommended I should take antihistamine at home. I took a 12-hour allegra about 12pm and a single 25 mg benadryl tablet at bedtime. The symptoms lasted about 3-4 hours before resolving. They did not get worse from the immediate reaction. Recommended contacting my family physician for advice of what to do before 2nd shot which is scheduled for Feb. 15, 2021
68 2021-01-26 blood pressure increased, heart rate increased immediate dizziness and elevated heart rate after vaccine, and somewhat elevated blood pressure afte... Read more
immediate dizziness and elevated heart rate after vaccine, and somewhat elevated blood pressure after an hour felt better, went home to bed with fatigue, slight nausea and headache
68 2021-01-27 low blood oxigenation Patient presented to the ED on 1/21/21 for evaluation of SOB stating her husband tested positive for... Read more
Patient presented to the ED on 1/21/21 for evaluation of SOB stating her husband tested positive for COVID earlier that week and she has been around him. The patient states her symptoms started 3-4 days prior to presentation. She admits to cough, nausea, and an episode of vomiting the day of presentation. She had been intermittently using her husband's oxygen prior to presentation which she says has helped with her symptoms, but does not use oxygen at baseline. Upon presentation the patient's oxygen saturation rate on room air is 89%. Patient was placed on 2L oxygen via nasal cannula and then was saturating in the mid 90s. CXR demonstrated bilateral patchy infiltrates in the ED which the ED physician felt to be consistent with COVID infection. The patient's rapid COVID test resulted as positive. The patient was admitted to the hospital for further management of hypoxia related to COVID infection. The patient remains hospitalized on the day of report submission (1/28/21)
68 2021-01-28 blood pressure increased 2 days after vaccine woke up at 1:30 am scalp was burning and face was tingling. Next day same thing... Read more
2 days after vaccine woke up at 1:30 am scalp was burning and face was tingling. Next day same thing and my pressure started going up. After 3-4 days, my hairline started receding slightly on the sides of my scalp in the front. This continued each day and I had to increase my blood pressure medicine and double the dose because it was getting so high. I was anxious and upset and am afraid to take the second dose because I feel that I will get a worse reaction, and am frightened.
68 2021-01-30 chest discomfort Adult emergency called in COVID vaccine tent. Pt experienced chest tightness, tongue numbness, and d... Read more
Adult emergency called in COVID vaccine tent. Pt experienced chest tightness, tongue numbness, and dizziness 5 minutes after receiving covid Vaccine. ***
68 2021-01-31 blood pressure increased 45 minutes after I received the vaccine, I began to itch on the left side of my neck and face. The o... Read more
45 minutes after I received the vaccine, I began to itch on the left side of my neck and face. The outer part of my neck swelled. The left side of My face became puffy and red. I had sharp prickly feelings in my top lip. And my blood pressure went extremely high 169/100. All this lasted about six hours.
68 2021-01-31 chest pain Chest pains 5 days after. Never had like that before And big red welt about three inches by 2 in... Read more
Chest pains 5 days after. Never had like that before And big red welt about three inches by 2 inches 2 weeks later. And arm is now aching
68 2021-01-31 pulmonary embolism, deep vein blood clot Concern comes from a pulmonary Embolism and DVT diagnosed within a week of the first shot. Realize... Read more
Concern comes from a pulmonary Embolism and DVT diagnosed within a week of the first shot. Realize this could be a coincidence, I have no history of clots.
68 2021-01-31 hypertension, lightheadedness feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was... Read more
feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was spinning; there is not enough spit in my mouth. It's very dry; I walked very slowly; slight headache; My blood pressure now is 137/93. It was high this morning; felt lousy like I had the flu; felt like I was fainting; This is a spontaneous report from a contactable consumer. A 68-years-old female patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included transient ischaemic attack (I had a TIA prior). The patient's concomitant medications were not reported. The patient experienced "feeling a little woozy/dizzy" on an unspecified date with outcome of unknown, "my head was sideways and every time I would raise my head the room was spinning" on an unspecified date with outcome of unknown, "there is not enough spit in my mouth, it is very dry" on an unspecified date with outcome of unknown, I" walked very slowly" on an unspecified date with outcome of unknown, "slight headache" on an unspecified date with outcome of unknown, "my blood pressure now is 137/93. it was high this morning" on an unspecified date with outcome of unknown, "feelt lousy like I had the flu" on an unspecified date with outcome of unknown, "felt like I was fainting" on an unspecified date with outcome of unknown. Reaction description by the reporter:" I had no pain, slight headache. My blood pressure now is 137/93. It was high this morning when I talked with the triage nurse. I had the shot/vaccine (first dose) on Friday. I feel better today than yesterday. Friday I felt fine. I got symptoms yesterday. When I woke up yesterday. I was feeling a little woozy, I always stretch slowly in bed. I slowly raised myself on the bed but before I got up my torso fell backwards. I felt like I was fainting. The room was spinning. All day yesterday I did not drive. I walked very slowly. I was holding onto the wall. I felt lousy like I had the flu. I would lay down for 20 minutes, watching tv. My head was sideways and every time I would raise my head the room was spinning. Also there is not enough spit in my mouth. It is very dry. I had a slight headache. So I did not bother but no headache today. I supposed to get my 2nd dose on 02Feb2021. The action taken was not applicable. Information on the Lot/Batch number has been requested.
68 2021-02-03 chest discomfort Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimm... Read more
Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
68 2021-02-03 palpitations Within 15-minutes of vaccination, the patient reported that their heart was racing. EMS managed the ... Read more
Within 15-minutes of vaccination, the patient reported that their heart was racing. EMS managed the patient's condition on-site.
68 2021-02-04 blood pressure increased, chest pain Patient began having chest pain initiating inferior to left breast and radiating upward through ches... Read more
Patient began having chest pain initiating inferior to left breast and radiating upward through chest approximately 5 minutes after receiving Pfizer Covid-19 Vaccine. Blood pressure taken ~7 minutes from administration was 125/67 mmHg and Pulse: 65 BPM. Pain waxed and waned and was not relieved from sitting down or standing up. EMT were called for possible heart attack, BP and pulse ~17 minutes after administration was 136/76mmHg and 76 BPM. EMTs arrived and brought her to ambulance for EKG which was normal. Patient stated she felt better and refused going to the hospital for further work-up. Prior to vaccine administration patient was at the gym on the treadmill for 30 minutes. unknown how long before vaccine administration
68 2021-02-04 blood pressure decreased, hypertension Within 10-minutes of vaccination, the patient reported feeling lightheaded. EMS assess the patient o... Read more
Within 10-minutes of vaccination, the patient reported feeling lightheaded. EMS assess the patient on-site and they were found to be hypertensive (152/88). No PMHx of HTN. Patient was anxious during evaluation. Their 12-leade EKG and other vitals were WNL. Patient's BP decreased (140/66) during the evaluation and refused transport to a hospital. Patient appeared improved and was in proper decision making capacity.
68 2021-02-06 oxygen saturation decreased With exercise, oxygen saturation drops as low as 79, I had oxygen concentrator at home , was on it 2... Read more
With exercise, oxygen saturation drops as low as 79, I had oxygen concentrator at home , was on it 24/7 for 4-5 days,, attached oxygen concentrator to CPAP at night, it has been two weeks, able to be off oxygen during day, since I live alone, still put oxygen on CPAP at night,
68 2021-02-07 heart rate increased, pallor Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ... Read more
Head fullness, sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ashy/pale complexion. Felt extremely weak in the evening.
68 2021-02-07 blood pressure increased, heart rate increased Pfizer-BioNTech Covid 19 Vaccine EUA Rash Elevated blood pressure Elevated heart beat ... Read more
Pfizer-BioNTech Covid 19 Vaccine EUA Rash Elevated blood pressure Elevated heart beat Dizziness and weakness Observed on site by EMS and nurses for approximately 1 hour
68 2021-02-07 chest pain, pulmonary embolism Starting having Chest Pain and SOB on 2/5/21. Had oxygen saturation of 85%. Went to ICC and then ER ... Read more
Starting having Chest Pain and SOB on 2/5/21. Had oxygen saturation of 85%. Went to ICC and then ER on 2/8/21 for these symptoms.
68 2021-02-07 pallor blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still hav... Read more
blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still having some type of reaction; She did have nausea this morning; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received bnt162b2 (BNT162B2; Lot # EL1283) , via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation . Medical history included cataract operation on 10Nov2020, oedema , swelling , brain operation on 2016 , aneurysm (aneurysm that did not rupture and there are 8 coils protecting that) , implantable cardiac monitor insertion , hypertension. Concomitant medication included lisinopril dihydrate (LISINOPRI)Lacetylsalicylic acid (ASPIRIN BAYER), amlodipine besilate (AMLODIPIN) pravastatin sodium (PRAVASTATIN) The patient experienced chills on 21Jan2021 with outcome of not recovered , her lips are a pinkish color as if she is still having some type of reaction on 21Jan2021 with outcome of not recovered , she did have nausea this morning on Jan2021 with outcome of unknown , blood shot right eye on 22Jan2021 with outcome of not recovered , she thinks she had an allergic reaction on 21Jan2021 with outcome of not recovered. The patient received Benadryl, Prednisolone and Ketorolac as treatment. Follow up information has ben requested.
68 2021-02-08 heart rate irregular, atrial fibrillation 6 hour run of AFib. I am a physician. I did not go to the hospital but had an irregularly irregular ... Read more
6 hour run of AFib. I am a physician. I did not go to the hospital but had an irregularly irregular pulse with light headedness, mild shortness of breath, and after spontaneous conversion felt tired.
68 2021-02-08 chest discomfort Pt c/o felt nausea, sweaty, ears became tingling and then went number. Was in placed in a wheelchair... Read more
Pt c/o felt nausea, sweaty, ears became tingling and then went number. Was in placed in a wheelchair and assisted to private location. C/o eyes feeling funny and tearing. next c/o chest pressure and tingling started down legs. Breathing labored and flushed skin. Epi administered and assisted to ER.
68 2021-02-11 blood pressure increased increase in blood pressure..156/96 for at least 6-8 hrs. ..blood pressure has not been elevated in 2... Read more
increase in blood pressure..156/96 for at least 6-8 hrs. ..blood pressure has not been elevated in 2-3 years. I took my prescribed blood pressure medication prior to bed time. This morning b/p is in normal range. other side effects: sore arm, leg and hip pain. This am has improved.
68 2021-02-14 chest pain, blood pressure increased Patient received 1st dose of Pfizer COVID-19 Vaccine around 3:30 pm on February 13th and was asked t... Read more
Patient received 1st dose of Pfizer COVID-19 Vaccine around 3:30 pm on February 13th and was asked to wait 30 minutes for observation due to previous history of anaphylaxis to peanuts and latex. Around 3:43pm patient stated she felt dizzy and light headed and appeared flushed. Her blood pressure taken at the onset of symptoms was 146/72 and patient stated she had chest pain (7/10 on pain scale). She stated she felt the same way when she had previous anaphylaxis so an epipen was administered and 911 was called. About 10 minutes later there was no improvement so a 2nd epipen was administered and she left with EMT. We have been unable to reach for follow up.
68 2021-02-15 fast heart rate, fibrin d dimer increased Sudden onset tired, exhausted, noted to be tacky cardiac. Check my pulse (retired RN, BSN,OCN.) ov... Read more
Sudden onset tired, exhausted, noted to be tacky cardiac. Check my pulse (retired RN, BSN,OCN.) over 150., peripheral and attempted to reck apical w stethoscope, Hard to count. Noted pulse 156 on Fitbit. Called local Urgent Care, Staff noted I sounded SOB on the phone, I was. Drove self to Urgent Care Office, EKG done -tacky, VS done, labs drawn. All labs WNL except D Dimer as >2. ++, (do not have in front of me). Was recommended that I go to ED- to be r/o for PE. Went to ED repeat EKG, Labs, CT scan w contrast and negative for PE. Discharged to home.
68 2021-02-16 hypertension, chest pain High bp and chest pain 10 minutes after vaccine. Aspirin and 2 nitroglycerin administered over 10 mi... Read more
High bp and chest pain 10 minutes after vaccine. Aspirin and 2 nitroglycerin administered over 10 minutes. Transferred from vaccine facility by ambulance to Hospital.
68 2021-02-17 chest pain, heart flutter fluttering heart; Started light headed; sharp chest pain; hard to take a breath; Face turned hot and... Read more
fluttering heart; Started light headed; sharp chest pain; hard to take a breath; Face turned hot and bright red/Felt like my head was on fire; Body ache all night; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265, expiry date: unknown), via an unspecified route of administration on 02Feb2021 at single dose (Right arm) for COVID-19 immunization. Medical history included Mild Asthma and Known allergies: Penicillin, Sulfa, Levoquin. Patient is not pregnant. Concomitant medication included prednisone (short course). The patient previously took bnt162b2 for COVID-19 immunization {product=COVID 19, brand=Pfizer,lot number=EJ1686, lot unknown=False, administration date=12Jan2021, vaccine location=Right arm, dose number=1}. It was reported that the patient started light headed, then sharp chest pain, fluttering heart, hard to take a breath. Face turned hot and bright red. Felt like my head was on fire. Body ache all night. Started happening about 3 hours after vaccine dose. Events started on 02Feb2021 13:00. Did not go to ER, no treatment. Stayed home and rested. The outcome of the events was recovering.
68 2021-02-18 chest pain Feb 5, 2021 at 8:45 started coughing as if having an allergic reaction to a cat. We stopped and g... Read more
Feb 5, 2021 at 8:45 started coughing as if having an allergic reaction to a cat. We stopped and got me some Claritin, cough drops, and water. Called my PCP and left message. Coughed an asthmatic cough Friday, Saturday, Sunday and Monday. On Monday, Feb. 8 called PCP again. We had a virtual visit. He said, it was not an allergic reaction. He prescribed Prednisone and Alburetol inhaler. On Thursday Feb . 11 I got a rash all over my body that came and went and I got Hives on the palms of my hands. Virtual visit with my PCP. He said that he retracted his statement from Monday and evidently I was having a reaction to the Vaccine. I kept taking the Steroid which I finished on Monday. The rash and hives bothered me till Monday. Tuesday and Wednesday rash and hives gone. On Thursday morning I woke up with a burning pain across my left side of my chest to the backside and pain on my knees. On Friday the pain was also on the backside of my waist. It felt like shingles. Went to see the NP at Dr. office. They don't think I have shingles. This is all still a reaction to the vaccine.
68 2021-02-18 blood glucose increased Severe migraine headache associated with visual distortion, nausea/vomiting, and prolonged word-find... Read more
Severe migraine headache associated with visual distortion, nausea/vomiting, and prolonged word-finding difficulty lasting at least a few days. No prior history of migraines. TIA work up ongoing.
68 2021-02-21 ischemic chest pain Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat clo... Read more
Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.
68 2021-02-21 hypertension Patient reported lightheadedness within 30 mins after vaccination. Patient denied any other symptoms... Read more
Patient reported lightheadedness within 30 mins after vaccination. Patient denied any other symptoms. Patient was also noted to be hypertensive (BP=160/100) upon taking vital signs.
68 2021-02-21 blood pressure increased Pt. in tent 23 at 2:05 pm at observation line. Complained of light headed and increased blood press... Read more
Pt. in tent 23 at 2:05 pm at observation line. Complained of light headed and increased blood pressure. Paramedics assessed pt. They monitored her until her symptoms subsided. Pt. was released. Husband drove her home.
68 2021-02-22 hypertension Pt. left tent 13 at 8:20 am. At observation site at 8:30 am, pt. was complaining of tingling lips a... Read more
Pt. left tent 13 at 8:20 am. At observation site at 8:30 am, pt. was complaining of tingling lips and feeling like blood pressure was high. Paramedics assessed vitals 160/90. Pt. was monitored until symptoms subsised. Paramedics released to leave at 8:55 am.
68 2021-02-22 hypertension Reported that she experienced slight blurry vision. Moved to observation chair- BP 124/76 pulse 72. ... Read more
Reported that she experienced slight blurry vision. Moved to observation chair- BP 124/76 pulse 72. Had 5 oz bottle of water. Reports that she has had high blood pressure. After 5 minutes- vision no longer blurry. Reported that she believe she was anxious.
68 2021-02-23 chest pain I had chest pains I am still having some. I went to the ER. They ran tests and found nothing wro... Read more
I had chest pains I am still having some. I went to the ER. They ran tests and found nothing wrong with my heart. The only thing I could think of was the shot since it started after the shot.
68 2021-02-23 chest discomfort Sudden Onset of Chest tightness and numbness in left arm. History of AFIB and Diabetes. PT Denies ... Read more
Sudden Onset of Chest tightness and numbness in left arm. History of AFIB and Diabetes. PT Denies SOB, Nausea, or Vomiting. Pt given 324 mg ASA prior to medic arrival. M48/L48 responded and evaluated patient including cardiac monitoring. Pt refused treatment or tx.
68 2021-02-23 heart rate increased Swelling in throat, tongue, face and then eyes. fast heart rate. rash on face and dizziness and we... Read more
Swelling in throat, tongue, face and then eyes. fast heart rate. rash on face and dizziness and weakness Give prednisone and benydrl in IV and took 1 50mg prednisone at home. Weakness for 3 days and swelling has gone down
68 2021-02-24 chest pain *On Saturday, February 20, 2021, I began feeling a slight burning sensation under my left side, unde... Read more
*On Saturday, February 20, 2021, I began feeling a slight burning sensation under my left side, under my armpit area. I also noticed small, red blotches. *By Sunday, February 21, 2021, there were more blotches that had spread across to my back and across my chest on the left side. There was severe burning, zinging pain that traveled across my chest, under my left arm, and across to my back. * Monday, February 22, 2021, I visited the Doctor who confirmed it was shingles. She prescribed 1 gram of Valacyclovir (Valtrex) 3x daily for 7 days. *The shingles have now covered my entire left breast, under my entire left arm area with a huge patch on my back. It has become extremely uncomfortable with much burning, stinging, and zinging that travels along the rash area and down my left arm.
68 2021-02-24 heart rate increased After 4 hours from injection had nausea and very rapid heartbeat. Went away after 2 hours
68 2021-02-24 pallor Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10... Read more
Pt received her first Pfizer COVID vaccine today at approximately 1305. She stated approximately 10 minutes into observation she developed abdominal pain and felt like she needed to have a BM. She sat on the toilet and had an episode of diarrhea and started to feel flushed, diaphoretic and stood up to go to the sink. She then felt nausea, dizziness and lightheaded and placed her head down leaning over the sink. EMT arrived to bathroom and sat patient down in a wheelchair. I arrived on scene shortly thereafter and the patient was pale and diaphoretic stating she did not feel well. EMS was activated. She was placed on the cardiac monitor and her HR was NSR in the 80's. BP 114/61, 96% on RA. Denied CP, SOB, rash, mouth, lip or tongue swelling. She was brought back to the observation area and was assisted to the gurney. Cool compresses were placed on her forehead and behind her neck. Medics arrived to scene to assess the patient. She stated she was feeling improved and did not want to go to the ED. She signed the AMA form. She was given water and crackers. She was monitored for 1 hour and stated she felt improved. She denied dizziness, lightheadedness, nausea or abdominal pain. I assisted her to the bathroom and she had one more episode of diarrhea. She stated she felt improved after that. She was monitored for 15 more minutes and stated she would like to go home. She was able to get up off the gurney without assistance, stated she felt well. She was ambulatory with a Steady gait and assisted outside. Prior to discharge I recommended she follow up with her PCP. Advised that she rest for the remainder of the day and to activate 911 should she develop any new or worsening symptoms. Advised that if she does get the second dose of vaccine she should be laying down at the time of administration and for 30 minutes after the injection for observation.
68 2021-02-24 blood pressure increased Redness @ injection site moving down arm to wrist, intense itching of arm with mild numbness, follow... Read more
Redness @ injection site moving down arm to wrist, intense itching of arm with mild numbness, followed by mild itching, swelling and redness of lips and perimeter of eyes, spike in blood pressure and dizziness, alleviated with paramedic?s IM inflection of 50 mg benedryl and a steroid pill at ER
68 2021-02-24 hypertension Within 15-minutes of vaccination, the patient reported pruritus around injection site, as well as pr... Read more
Within 15-minutes of vaccination, the patient reported pruritus around injection site, as well as pruritus and edema in her face, around her mouth and eyes. Patient denied SOB, CP, Abdominal pain, N/V, or HA. EMS evaluated patient on-site. The patient was hypertensive (174/86). Due to patient's complaint and physical exam, EMS administered Benadryl 50mg IV. EMS transported patient to Largo Medical Center Emergency Department. In the ED, the patient had bilateral palpebral edema, pruritus surrounding injection site spreading down the extremity, and lips were erythematous. No SOB or tongue/throat swelling noted. Patient was hypertensive (164/72). ED Physician administered PO Pepcid and Prednisone by provider in triage. The patient stated they felt improvement after the Benadryl treatment and requested to be discharged from ED. Patient was given information and strict return precautions about anaphylaxis.
68 2021-02-25 hypertension Lightheaded, high bp. Pt rest for about 30 mins and bp decreased and pt light headless subsided. Pt ... Read more
Lightheaded, high bp. Pt rest for about 30 mins and bp decreased and pt light headless subsided. Pt was released back to observation area and pt went to checkout.
68 2021-02-25 chest pain One week after shot had chest pain on left side. Later the pain radiated to the right side and got w... Read more
One week after shot had chest pain on left side. Later the pain radiated to the right side and got worse. After a week of no improvement I went to ER and was diagnosed with pleurisy and pleural effusion. Currently taking antibiotics.
68 2021-02-25 chest pain Patient went to the restroom after her vaccine and when she came out, she was walking to her seat an... Read more
Patient went to the restroom after her vaccine and when she came out, she was walking to her seat and had mid-sternal chest pain.
68 2021-02-25 hypertension sustained high blood pressure; Have 2 aneurysms; Continuous headache; some dizziness; This is a spon... Read more
sustained high blood pressure; Have 2 aneurysms; Continuous headache; some dizziness; This is a spontaneous report from a contactable 68-year-old female consumer reported for herself. A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9262), via an unspecified route of administration (right arm) on 26Jan2021, 17:15 at SINGLE DOSE for covid-19 immunisation, at 68 years old. Medical history included allergies: Penicillin from an unspecified date. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is taking unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH 9899, at 68 years old), on 05Jan2021, 16:30, right arm for COVID-19 immunization. The patient experienced sustained high blood pressure, have 2 aneurysms, continuous headache, and some dizziness on 26Jan2021. Therapeutic measures were taken as a result of the events which include 3 different blood pressure medications, still not under control; medications and monitoring of pressure. She mentioned she has 2 aneurysms so she needs to keep her pressure normal. Outcome of the events was not recovered. The event was considered non-serious by the reporter.
68 2021-02-26 palpitations 11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:... Read more
11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:30 eggy taste, slight shot ache, 4:30 light headache, 02/13/2021 2:30am woke with a rush feeling of med, started coughing, burst (spread) of warmth in center of chest, slight perspiration; 3:30am heart racing, warmth in chest, modest itchiness(arm, face & torso), soreness at injection site. 02/14/2021 7am burning/ itching injection site, & chest/torso arm red and square blotch about 1 1/2 inch very itchy and burning for several days. 02/23/2021 itchinesss better. Brown square area at site of injection. There is still a slight itch at times as if healing.
68 2021-02-26 chest pain, chest discomfort Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itch... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itching. Shortly after, developed a dry cough and reported that her throat "felt funny." Patient began vomiting and having difficulty breathing, speaking in 1-2 word sentences. Pt received epi pen to left thigh, with some resolution of symptoms. Pt continued to have cough and nausea, chest pain. Gave 25 mg benadryl IM at 08:27 am. Patient received 2nd dose of Epi for increased SOB, difficulty breathing, and increasing cough, with some resolution of symptoms. Patient reported increased chest pressure. Began having seizure like activity at 08:30, lasting approx 20 seconds with no post ictal period noted. EMS arrived after 2nd dose of epi. Second "seizure like" activity after EMS arrival, lasting approx 20 seconds. During transport to ambulance, patient had 2 more episodes of seizure like activity with no post ictal phase. ED note states low suspicion for true seizure since patient was awake during episodes of tonic clonic movements, answering questions during, and did not have post ictal state.
68 2021-02-27 chest discomfort Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom ... Read more
Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom the last 3 days on hands and knees. Lethargic . Tired. Fatigue. 4 days now. And I am getting worse. Heaviness on chest
68 2021-02-28 heart rate increased Approximately 15 minutes after receiving vaccine, patient noticed she was having double vision. She ... Read more
Approximately 15 minutes after receiving vaccine, patient noticed she was having double vision. She was trying to focus on a sign we had in the waiting room, and the words started blurring and doubling. BP was normal, heart rate was slightly elevated. With time (about 10 minutes), patient reported it was improving. We got patient to her feet first to ensure balance wasn?t effected and then patient reported she was ok to leave.
68 2021-02-28 palpitations Palpitations, weakness-cleared by EMS
68 2021-02-28 chest discomfort Patient had shortness of breath and complained of tightening felt in the throat chest area after her... Read more
Patient had shortness of breath and complained of tightening felt in the throat chest area after her initial 15 minutes of observation post vaccination. She was coherent and verbalizing the entire time. She was observed while 911 was called. She stated she was feeling better and her symptoms were resolving as she sat for 10 minutes. She was taken to a different facility ER for assessment (Kaiser). When we spoke to her later at night, she was home and said she did not receive any treatment while at the ER.
68 2021-03-01 chest pain, chest discomfort Beginning 3 days after my vaccination I began to experience chest pain and tightness sporadically th... Read more
Beginning 3 days after my vaccination I began to experience chest pain and tightness sporadically throughout the day and night for the next 5 days. No fever. Then at the end of those 5 days, it seemed my lungs, right one in particular, had pain and I developed a cough. I had a small amount of pain when breathing, especially breathing in. It felt very similar to an episode of Pleurisy I had quite a few years ago. I do have seasonal allergies and had been sneezing off and on in the days previous to the vaccination and also afterward. Symptoms have since lessened considerably and have almost disappeared. I am curious to know if this was in any way related to the vaccination, or purely coincidental.
68 2021-03-01 blood pressure increased, heart rate increased My heart rate and b/p increased evening after injection. My heart rate and b/p have been maintaine... Read more
My heart rate and b/p increased evening after injection. My heart rate and b/p have been maintained at normal ranges for years! B/P usually 122/76 and heart rate 76-80. Since I got that vaccine, each evening my heart rate has been 97, 87, 94, 90. B/P 133/85, 145/84. I had flu-like symptoms, headache, injection site pain and joint pain. They subsided.
68 2021-03-01 pulmonary embolism multiple bilateral Pulmonary emboli; pulmonary hypertension; short of breath; right heart strain; Th... Read more
multiple bilateral Pulmonary emboli; pulmonary hypertension; short of breath; right heart strain; This is a spontaneous report from a contactable nurse. A 68-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number=EH9899), via an unspecified route of administration at right arm on 22Dec2020 08:00 AM at single dose for COVID-19 immunisation. Medical history included uveitis, arthritis and known allergies: pine nuts. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. The patient was not pregnant. Concomitant medication included prednisone (eye gtt), naproxen as needed (PRN) less than weekly. The patient previously took theophylline and experienced allergies. The day after getting the first dose of vaccine the patient worked all day in another (clinic withheld). She felt well all day, but at 6 pm when she left to go to her car she was so short of breath she had to stop twice to get there. Subsequent work up has shown that she had multiple bilateral Pulmonary emboli resulting in pulmonary hypertension and right heart strain. Adverse event start date was 23Dec2020. Adverse event start time was 06:00 PM. The adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 1 day, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events included Lovenox and Eliquis. The outcome of the event was recovering.; Sender's Comments: Based on available information and known drug profile the reported events are unlikely related to bnt162b2 . These are probably intercurrent medical condition. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-03-02 hypertension 3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face... Read more
3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face, and then some "rubbery" weakness in my arms and legs. Treated in an ambulance at vaccine site with IV Benadryl, had some skin tingling, also given IV solumedrol and observed for almost 2 hours with no other symptoms. I was also hypertensive, probably due to anxiety.
68 2021-03-02 chest pain About two hours after receiving the Pfizer vaccine shot #1, my left arm became numb and stiff, start... Read more
About two hours after receiving the Pfizer vaccine shot #1, my left arm became numb and stiff, starting at my wrist and worked up my upper arm. I could not lift my left arm at all, but when I tried, the pain was severe and radiated over the left half of my chest and over my heart. I thought this might be a passing reaction, and went to bed early. My condition was the same in the morning, and I contacted my doctor, who directed me to go to the emergency room or to Urgent Care, which I did.
68 2021-03-02 chest pain None at the time of vaccination. Pt admitted to ER on 2/25 with chest pain.
68 2021-03-02 palpitations Palpitations, anxiety, and dizziness. BP 144/76 (pulse 66), and stabilized after receiving albuterol... Read more
Palpitations, anxiety, and dizziness. BP 144/76 (pulse 66), and stabilized after receiving albuterol.
68 2021-03-02 hypertension Severe headache, extremely high blood pressure 220/120, low blood sugar, anxiety, insomnia
68 2021-03-03 palpitations, heart rate increased Within 45 minutes of getting the vaccine she started having a fast, racing heart beat. This reactio... Read more
Within 45 minutes of getting the vaccine she started having a fast, racing heart beat. This reaction lasted for about 15 minutes. She has had no other reactions since the vaccine, no fever, headaches or anything. This episode only happened once, and has not returned. She laid down and it stopped. She spoke with her allergist today while getting her allergy shot who told her to report the reaction to us.
68 2021-03-03 heart rate increased, chest discomfort, chest pain she felt extreme pressure when she breathed, like an elephant sitting on her chest; Extreme chest pa... Read more
she felt extreme pressure when she breathed, like an elephant sitting on her chest; Extreme chest pain/chest pain was not like a heart attack, but she felt a lot of pressure and weight when she was breathing in; heart rate went up (from 89 to 99); Pains; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date unknown), via an unspecified route of administration on the left arm on 24Jan2021 09:22 at a single dose for COVID-19 immunization. Medical history included degenerative disc disease (first disc came out) from 2007, chronic fibromyalgia from 2005, rheumatoid arthritis from 2000 (went into remission for a few years; while in remission, she was diagnosed with fibromyalgia), vertigo (diagnosed when she was 24 years old; bout of vertigo about twice a year; last year, 2020, was the worst bout of vertigo she ever had), allergy to shellfish (hives, itching, welts), sulfa (anaphylactic reaction), and mostly pain related issues. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient wanted to know if she should get the second dose of the COVID vaccine knowing that she had a reaction to the first dose. She had a reaction which she believed was from the vaccine she received. She felt something immediately but did not concern herself with it, was kept for 30 minutes for observation. Her heart rate went up (from 89 to 99) and then her heart rate came back down. She said after the 30 minutes had gone by, she felt better. On 25Jan2021 and 26Jan2021, she felt extreme pressure when she breathed, like an elephant sitting on her chest which lasted all day. Patient woke up the next morning and pains were still there. It was also reported that the patient had extreme chest pain on 25Jan2021. She said that the chest pain was not like a heart attack, but she felt a lot of pressure and weight when she was breathing in. By the time she went to bed in the night of 25Jan2021 night, she felt fine. When she got up the next day, Tuesday, 26Jan2021, and started moving around, the chest pain came back. When she woke up on Wednesday, 27Jan2021, everything was all gone. Patient is scheduled for her second COVID-19 vaccine shot on 14Feb2021. The events did not require a visit to emergency room or physician office. The patient recovered from the chest pain on 26Jan2021, from heart rate went up on 24Jan2021, and from the other events in Jan2021.
68 2021-03-04 blood pressure increased 30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient w... Read more
30 minutes post vaccination, patient's voice was hoarse, face flushed, appeared restless. Patient was coughing and clearing throat. Fluids were offered and patient was moved to a more private area, vitals were taken. Pulse ox 96% RA, blood pressure was elevated, HR was 86 bpm. Rapid response team was notified and took the patient to the hospital's emergency department.
68 2021-03-04 blood pressure decreased, heart rate increased found by husband with AMS on 3/4/21, not responding to questions or following commands. taken to the... Read more
found by husband with AMS on 3/4/21, not responding to questions or following commands. taken to the ER- fever 101.2, HR elevated, decreased BP
68 2021-03-04 hypertension week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pres... Read more
week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pressure; felt a weird sensation; Tingling in her head and her face; pain in the head and got increasing worse/scalp felt on fire/light headache; scalp felt on fire; she felt a little soreness in arm/12 hours my arm hurt; This is a spontaneous report from a contactable consumer (patient's cousin). A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/Lot number: EL9262), via an unspecified route of administration on the left arm, at age 68 years first dose on 20Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included ongoing anxiety from an unknown date. Ongoing concomitant medication included escitalopram 5 mg for anxiety, calcium and an unspecified multivitamins. The patient had flu vaccine in Oct2020. Patient's cousin called on behalf of cousin and reported that patient was very ill for having severe reaction to the COVID Vaccine. Patient was physically fit and thin received first dose of COVID vaccine on 20Jan2021, 10:30 AM. After her 1st dose, she felt a little soreness in arm, 12 hours her arm hurt and light headache the same day. Patient went to bed a little earlier than normal and slept a little longer since she was 69 years, its her body and it needed more sleep and woke up at noon and her arm was fine and very grateful to have the shot. Two nights later, on 22Jan2021, patient woke up in the middle of the night with tingling and pain in the head and got increasing worse, her scalp also felt on fire and had tingling sensation in her face for 3 weeks. Then, a week after the 1st dose on 27Jan2021, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation on an unspecified date and as she noticed some spikes in her blood pressure, her MD told her to take another 2.5 mg amlodipine if needed (once or twice a day as needed). She confirmed she had no heart rate problems but she actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. The outcome of the event 'eek after the 1st dose, her blood pressure went up to 210/101/noticed some spikes in her blood pressure' and 'tingling in her head and her face' was not recovered, for event 'she felt a little soreness in arm/12 hours my arm hurt' was recovered on 21Jan2021, while for the other events, it was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187054 same patient/drug, different event
68 2021-03-05 chest pain Bad chest pain, hard to take a deep breath, headache, dizziness, diarrhea. By the end of the day, be... Read more
Bad chest pain, hard to take a deep breath, headache, dizziness, diarrhea. By the end of the day, because of chest pain and dizziness my doctor sent me to the ER. I was then referred to a cardiologist, who indicated he thinks these symptoms are from the second dose of vaccine. He has seen several patients with the same symptoms after the second vaccine dose. My family doctor now thinks the same thing for the same reasons.
68 2021-03-06 blood glucose increased About 11 hours after receiving vaccine vomited repeatedly, had chills and then short periods of feel... Read more
About 11 hours after receiving vaccine vomited repeatedly, had chills and then short periods of feeling very warm. Taste was off- many foods just did not taste good. General body aches, ambulation unsteady, blood sugar went up to over 700. This lasted until about 11 the next morning.
68 2021-03-06 heart rate increased, chest discomfort Ten days after the first shot and four days after the second shot I experienced two episodes of che... Read more
Ten days after the first shot and four days after the second shot I experienced two episodes of chest tightening, increased heart rate, and pain that radiated around to my back. Each episode lasted about 15 minutes. During the second episode, I checked my heart rate on my watch. It was 110+.(I forgot to do it the first time) Both times I was sitting down doing a jigsaw puzzle . Not exactly stressful or physically taxing.
68 2021-03-06 chest discomfort Tightness in chest, chills, sore throat, fatigue extreme, headache, bodyaches and joints, blurry eye... Read more
Tightness in chest, chills, sore throat, fatigue extreme, headache, bodyaches and joints, blurry eyes, nausea, no appetite.
68 2021-03-07 chest discomfort Patient developed swelling and redness in the face, tightness in the chest, and nausea in the stomac... Read more
Patient developed swelling and redness in the face, tightness in the chest, and nausea in the stomach.
68 2021-03-07 chest discomfort, chest pain Woke up at 3 so cold, I rolled my shoulders in to keep warm. So my chest is really hurting. I took... Read more
Woke up at 3 so cold, I rolled my shoulders in to keep warm. So my chest is really hurting. I took my temp and it was 100. I was so cold I thought it was 102. I drank water and took nyquil. I was able to sleep better. I still have a fever of 100, however not feeling as bad. However my chest is very tight.
68 2021-03-08 chest discomfort, palpitations Reaction: Dizziness (not initially reported), heavy chest (similar to when she has had arrhythmias i... Read more
Reaction: Dizziness (not initially reported), heavy chest (similar to when she has had arrhythmias in the past) and racing heart Outcomes: Patient brought to floor with feet elevated. Vitals taken and O2 given. Symptoms resolved while supine, but patient continued to be dizzy when she was sat up. Transported to ED and symptoms resolved.
68 2021-03-08 fainting, blood pressure decreased Vasovagal Syncope Sudden drop in blood pressure. occurred day after vaccination 9:00pm Called my c... Read more
Vasovagal Syncope Sudden drop in blood pressure. occurred day after vaccination 9:00pm Called my cardiologist. Encouraged to monitor and keep them informed reduce blood pressure meds until stable. Discontinue chlorthalidone until BP is stable Blood pressure seems to be stable today (3-9-10). Still slight headache and mild dizzy spells
68 2021-03-08 hypertension Within 15-minutes of vaccination, the patient reported a diffuse pruritic rash with hives, dizziness... Read more
Within 15-minutes of vaccination, the patient reported a diffuse pruritic rash with hives, dizziness, blurred vision, and SOB. EMS evaluated the patient on-site. Patient was hypertensive (173/92). EMS administered 50mg Benadryl IV and 2L Oxygen via nasal canula. Given past medical history of allergic reactions, EMS transported the patient to Hospital Emergency Department. In the ED, the patient remained hypertensive. EKG demonstrated NSR, rate 75bom, no ST-T changes, no ectopy, and normal PR & QRS intervals. Blood work was unremarkable. After administration of Benadryl the patient noted improvement of their hives and was discharged with a diagnosis of allergic reaction secondary to COVID vaccine that caused acute hives.
68 2021-03-09 chest discomfort 2nd Pyzer Shot 2/8/2021 2:54 PM I believe I had an allergic reaction the first night: Arm twitched s... Read more
2nd Pyzer Shot 2/8/2021 2:54 PM I believe I had an allergic reaction the first night: Arm twitched several times approx. 6-7pm,Light headache approx. 8pm Anxiety increased between 8pm-2am,Woke 3:49 am with bad headache in rear of head, went to bathroom and turned over. Woke up with bad headache a little while later, Several times woke up struggling to swallow. Last time I woke up with Difficulty breathing and pressure on chest Decided I needed to wake my husband, but that is my last thought or action until I woke up 9AM. I take a generic Zyrtec at supper time each night. I think had I not had Zyrtec these symptoms could have been serious. Was OK until 3 – 11pm 3/9/2021 Slight headache & Shortness of breath.
68 2021-03-09 heart rate increased Patient received the Covid-19 vaccine. She reports symptoms of dizziness, high heart rate, sweaty. ... Read more
Patient received the Covid-19 vaccine. She reports symptoms of dizziness, high heart rate, sweaty. 1145: Patient states she feels like she has a sensation of swelling, itchy legs. Patient is requesting Benadryl. 1147 Benadryl 25mg given by RN. Phone call made to patient's son to come to the clinic to accompany patient home. 1217 Patient states she feels much better, slight dizziness. 1244 Patient's son arrived. Patient states she feels better and wanted to walk herself out of the clinic. Patient will contact her PCP if she has anymore questions or concerns. Vitals taken: 1135: 158/98 120 96% RA 16R 1142: 162/98 110 99% 2L 18R 1152: 160/92 83 98% 2L 18R 1244: 150/80 108 98% RA 18R Treatment/intervention patient was given: 25mg Benadryl PO
68 2021-03-09 lightheadedness got dizzy and almost passed out; got dizzy and almost passed out; had slight pain at injection site/... Read more
got dizzy and almost passed out; got dizzy and almost passed out; had slight pain at injection site/awoke with moderate pain (5/10); This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL9262), via an unspecified route of administration at the site of left arm at 12:45 on 28Jan2021 at single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. Clinical course: patient was vaccinated about 12:45 pm with no ill effects. When she went to bed, she had slight pain at injection site. She awoke with moderate pain (5/10) about 1 am. She got up to get some paracetamol (TYLENOL). On the way to the kitchen, she got dizzy and almost passed out. She found a chair and rested. She went back to bed (with no paracetamol). No other problems. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. Adverse reactions did not result any serious consequences. The outcome of events was recovered on an unspecified date.
68 2021-03-10 palpitations Heart Palpitations, uncontrollable Even Resting in bed,,, heart rate stayed double as normal to 15... Read more
Heart Palpitations, uncontrollable Even Resting in bed,,, heart rate stayed double as normal to 155 and flucuated between 130 - 155 for 2 days. Heart rate would not return to my normal rate of 62-68 BPM for 2 and half days. ALSO Left arm at injection site, pain and soreness. ALSO Left underarm to left breast, very sore, swollen lymp areas, left arm pit inflamed, red and swollen. 2 days since shot.. heart rate back to normal, but left arm and left underarm very sore, swollen
68 2021-03-10 chest pain Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergen... Read more
Three days after dose 1 I experienced dizziness and violent vomiting (for 8 hours). Taken to emergency room. Admitted to hospital for hospital for 1 day. Was given anti-vomiting/dizziness drugs, CT scan, IV for dehydration, pain and anxiety medicine. Diagnosis was vertigo. Upon release from hospital, consult with internist further diagnosed condition as labarynthitis. Headache and slight dizziness continued for a couple of weeks . After second dose dizziness, light-headedness and headache are significant enough to take Tylenol regularly. These effects are still in place 12 days after 2nd dose. Will see internist if symptoms continue after 2 weeks.
68 2021-03-11 hypertension 3 hrs after 1st vaccine developed bad headache, lasted about 36 hrs and then completely resolved. 1... Read more
3 hrs after 1st vaccine developed bad headache, lasted about 36 hrs and then completely resolved. 12 hrs after 2nd vaccine, same headache last about 24 hrs then completely resolved Feb 28 same headache suddenly redeveloped and have been chronic since that time along with new dx of HTN. Seen by doctor 2 times and ER that did CT of head/EKG/labs all normal so final discharge dx was migraines with HTN. I have never had headaches or HTN in my past medical history. Rx Lisinopril 10mg and Medrol 6 day dose pack have done little to relieve these symtoms.
68 2021-03-11 blood pressure increased, chest discomfort, palpitations Client received the first dose of her Pfizer COVID-19 vaccine and during the post-vaccination wait p... Read more
Client received the first dose of her Pfizer COVID-19 vaccine and during the post-vaccination wait period, she complained of feeling warm, palpitations and tightness in the chest. ?911? was immediately called. She denied any itching or difficulty breathing and stated that she has a history of allergies as well as hypertension, for which she takes Lisinopril, 30mg and Lasix, 40mg. She also indicated that prior to coming in for the vaccine, she took some steroids and antihistamines at the suggestion of her primary care physician. Vital signs were as follows: BP=174/100, Pulse=111. A recheck of her BP was 200/110. The EMT ? responded to the call. They evaluated the client, treated her with an EpiPen and started an IV line. At 11:15, she was transported to the hospital.
68 2021-03-11 fainting Diarrhea (usually 4+ times per day) began on 2/20/2021, and continues to today (3/12/2021). Fainte... Read more
Diarrhea (usually 4+ times per day) began on 2/20/2021, and continues to today (3/12/2021). Fainted 2/26/2021. To Urgent Care and then ER 2/27/2021. Suspected dehydration.
68 2021-03-11 heart rate increased Fever as high as 102.4 (took Tylenol at 1:30 a.m. on 3/11/2021), shaking chills, elevated heart rat... Read more
Fever as high as 102.4 (took Tylenol at 1:30 a.m. on 3/11/2021), shaking chills, elevated heart rate (up to 107) (all overnight on 3/10-11/2021). Felt sluggish during day of 3/11/2021 with low grade fever, mild chills (took Tylenol one more time at 11:00 a.m. on 3/11/2021). Rested most of day. Overnight of 3/11-12/2021 woke up at 4:30 a.m. completely drenched, but no further fever, chills or elevated heart rate. Have felt fine on 3/12/2021.
68 2021-03-11 fibrin d dimer increased Patient hospitalized on 3/9/21 with one week history of fever, chills, and shortness of breath. Tes... Read more
Patient hospitalized on 3/9/21 with one week history of fever, chills, and shortness of breath. Tested positive for COVID-19. Respiratory status worsened on 3/11 requiring transfer to ICU and intubation. Currently intubated in ICU.
68 2021-03-12 palpitations, blood pressure increased 34 after my 2nd vaccination I had severe palpitations. Knocked me out of bed. Lasted for hours. Ha... Read more
34 after my 2nd vaccination I had severe palpitations. Knocked me out of bed. Lasted for hours. Have had palpitations and sequela since, including elevated BP, some shortness of breath, nausea.
68 2021-03-12 hypertension Headache, aches within 8 hours. Within 20 hours developed severe vertigo and nausea. Movement caused... Read more
Headache, aches within 8 hours. Within 20 hours developed severe vertigo and nausea. Movement caused room spinning and broke out in cold sweat. Severe vertigo continued through second day (Feb 22), but seemed to diminish somewhat toward evening. Day 3 still had moderate vertigo/nausea but better than previous day. Went on a long walk. Day 4 moderate vertigo/nausea continued. Tried doing Epley exercises for vertigo. Vertigo/nausea became severe again, so severe I vomited several times. After vomiting got the shakes and felt very cold. Checked blood pressure and it was very high (170/98), but pulse rate was in low 30s. After a few hours blood pressure and pulse rate became closer to normal. Almost decided to go to ER clinic, but decided to wait until my daughter came home from work because I was way too dizzy to drive. After I calmed down I decided it wasn't an emergency. Severe vertigo continued through evening of day 4. On day 4 I called primary care doctor to see if there was anything I could do for the vertigo. She prescribed meclizine, but hearing that it is an antihistamine, I declined it (antihistamines make my heart race and make me very anxious). Severe vertigo/nausea continued through day 5 and day 6. (Severe vertigo/nausea being that I could not move around at all other than to sit still staring forward without the room spinning.) All this period I also had a headache, a feeling of pressure through my whole head/sinus area, and my vision was blurred. I also felt as though I could not focus my eyes or concentration. I tried using some over-the-counter nasal decongestant spray for 2 days to relieve congestion in head, but they made me feel very anxious, so I stopped. I also tried taking some Aleve a couple of times. It helped a little, but made me feel woozy, so stopped. Day 6 the vertigo/nausea improved to moderate, but I could still not walk straight. I felt unsafe to drive. Day 7 continued to improve, but still moderate vertigo/nausea. Day 8 I noticed a lot of improvement in vertigo/nausea. Kept improving day 9. By evening on day 10 I was noticing a rawness and lump in the back of my throat. Called primary care office day 11 to see someone. Drove car, but felt marginally safe driving. Was diagnosed with a sinus infection and prescribed a 10 day course of Amoxicillin/Clavulanic Acid (875-125 mg for 2 pills a day for 10 days). Felt improvement in throat and sinus over next few days. Day 15 I felt greatly improved with head ?fog? and vertigo. Had an appointment with an ENT clinic on day 15 to see what was causing vertigo. All tests were good for hearing, and visual examination of ears. Was checked for BPV but that was ruled out. Said vertigo was probably caused by viral infection or inflammation of vestibular nerve or canals. Recommended waiting for improvement and coming back if it persisted. Began doing more normal activities even though I still had mild vertigo. Day 16 felt still better in morning, then in afternoon bent over quickly to catch something and got a terrible wave of spinning again. Moderate/severe vertigo continued that evening. Improved to moderate on day 17 and 18. All along, when vertigo was worse, so was the ?fog? (blurry vision, inability to focus mentally). At day 19 I feel like I did on day 15, but I have noticed the pressure/lump around my ear and on left side of head is improved. Brain ?fog? is improved too, very mild and the vertigo is mild. I finish my antibiotic tomorrow.At present vertigo is not gone. Its mild today, but this is only one of maybe 2 1/2 days in which its been this mild (out of almost three weeks since I was vaccinated). I have been drinking a lot of water every day, and ginger tea when I get nauseous. I had my 2nd dose of the COVID Pfizer vaccine scheduled for Mar 15. I?ve cancelled it and intend to wait to see how long it takes for vertigo to finally resolve before considering a 2nd dose.
68 2021-03-12 hypertension Prior to vaccine had normal blood pressure on January 6th for physical and check ups and all previou... Read more
Prior to vaccine had normal blood pressure on January 6th for physical and check ups and all previous visits. After the vaccine, blood pressure was elevated and extremely high and has been subsequently. Have gone through testing such as blood work, EKG, Echocardiogram and several more tests scheduled. All tests thus far have not found any issues. In the meantime I have been put on Losartan HCTZ 100-12.5 and then added Amlodipine Besylate 5 MG.
68 2021-03-13 chest pain Almost immediate fatigue that lasted about 5 hours. Slight headache. Later that night while sleepi... Read more
Almost immediate fatigue that lasted about 5 hours. Slight headache. Later that night while sleeping I woke up and could not breathe and my chest hurt. It lasted about 15-20 minutes. I would like to know if it is safe for me to take the second dose as I have heard from friends that it was a little bit more difficult if you had side effects.
68 2021-03-15 cerebrovascular accident 4 days after I had the 1st shot I had an optic nerve stroke in my right eye with complete and perman... Read more
4 days after I had the 1st shot I had an optic nerve stroke in my right eye with complete and permanent vision loss
68 2021-03-15 chest discomfort Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on m... Read more
Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Arm was sore; Had light headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken daily. The patient experienced light headedness and pressure in her chest that went to her left shoulder and jaw. Patient had light headache, pain in chest, and pain in jaw. She woke up this morning feeling better but still had slight pain in jaw. Wondering if side effects are from vaccine and will she be ok. Patient stated, "I have the first dose of the vaccine on 22Jan2021, I didn't have any side effect, my arm was sore but nothing big. But yesterday I feel light headed, like pressure in my chest, kind of pressure on my jaw and shoulder, my left shoulder, and my vitals were okay like my blood pressure, my heart rate and everything was normal. Further she explained this morning I felt better I didn't have pressure on my chest or anything but the pressure on my jaw that go up to my head. Is that related to the vaccine or is something that I have to worry about?" Consumer stated, "The second one is going to be on 12Feb2021, this Friday." Patient stated, "No, I was calling because today I feel better, I don't have the pressure on my chest. But I still have the pressure on my jaw and on my kind of my head. But no I have not called anybody. It's not like an emergency, I am calling because I was not sure about this is related to the vaccine." For treatment consumer stated, "No, today I took some Tylenol, that's all." No investigation assessment. The outcome of the event 'Light-headed' was recovering, the patient recovered from the event 'Pressure in my chest' on an unspecified date, was not recovered form Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head and was unknown for other events. No follow-up attempts needed. No further information expected.
68 2021-03-15 skin turning blue Lightheaded and weak 11 am March 15th fever of 100.2 with Tylenol all day shaking chills with hot an... Read more
Lightheaded and weak 11 am March 15th fever of 100.2 with Tylenol all day shaking chills with hot and cold spells, rattling chills so I could not even text with my fingers, extremities cyanotic, but that is usual for me when I am very cold. Got into a very hot tub of water and stayed until my core warmed up. Spell lasted about 2 hours and then resolved. Felt much improved on 3/16/21
68 2021-03-15 blood pressure increased, palpitations chills all night , arm somewhat sore, when I got up to use the bathroom my heart pounded vey hard an... Read more
chills all night , arm somewhat sore, when I got up to use the bathroom my heart pounded vey hard and could feel below the esophagus area, March 12 at 6:30 am T 99.9, BP 151/85 achy , took tylenol and at 8:40 am BP 128/ 74 P 93, my back ached all day, 3:45 pm BP 141/74 P 90, Took tylenol for achy body, 6:00pm BP 158/82 P 84, 8:08pm BP 138/73 P82 . Felt very tired and slept in my chair 3:30- 6:00 pm, felt really exhausted and went to bed early : slept 9:00pm-7:00 am . Saturday 3/13 /21 felt better T 97.3 BP124/69 P 64 felt fairly good all day but tired
68 2021-03-17 palpitations #1 2/15/21 Pfizer - lump under arm 2-3 days, right side back pain - took muscle relaxer and aleve fo... Read more
#1 2/15/21 Pfizer - lump under arm 2-3 days, right side back pain - took muscle relaxer and aleve for 2 days, better, #2 3/8/21 - lump under arm, palpitations 3/9/21 lasting 1 1/2 days, left side swelling on back 3/15/21, went across lower back, by 3/17/21 back pain worse and felt like couldn't breathe due to back muscle spasms went to ED, sore but better today 3/18/21
68 2021-03-17 fibrin d dimer increased Patient developed shortness of breath on exertion.
68 2021-03-17 hypertension Within 30-minutes of vaccination, the patient reported sudden onset dizziness when they stood up and... Read more
Within 30-minutes of vaccination, the patient reported sudden onset dizziness when they stood up and near-syncope. EMS evaluated the patient on-site. The patient was hypertensive (171/92). EKG performed by EMS demonstrated sinus brady, rate 58bpm, No ST elevation. FSBG: 71mg/dL. EMS administered IV fluids. EMS transported the patient to Hospital Emergency Department. In the ED, the patient remained hypertensive (159/82). Pertinent lab tests were EKG: NSR, No ST-T changes, no ectopy, normal PR & QRS intervals and CMP/CBC/UA: Unremarkable. During evaluation the patient reported feeling improved and was discharged with diagnoses of dizziness and hypertension.
68 2021-03-18 heart flutter Heart flutters and tickling in bronchial tube for several hours. In the past when I had this reacti... Read more
Heart flutters and tickling in bronchial tube for several hours. In the past when I had this reaction to a different combination of medications, it progressed to spasms and I couldn't get my breath for several minutes. My reaction to the covid vaccine didn't progress to that degree, so I didn't report it. A friend suggested that I contact you to see if it is safe for me to take the second shot since the reaction is often stronger after the second dose. I am scheduled to receive that second shot Monday. My only other reactions to the first dose were chills and fatigue, and minor soreness at site of injection.
68 2021-03-18 fainting She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vacci... Read more
She had the vaccine at the facility where she lives. She fainted less than 24 hours after the vaccine, got up from that and had dry heaves, lost her speech and had loose stools. The aide caught her as she was fainting as she would have fallen on the floor. She said it was weird, she looked at people and it looked like they were 2 dimensional and knew something was wrong, but couldn't figure out what as they attended to her. They asked her questions, but she was not able to speak to them. They apparently spent 2 hours with her, but she doesn't believe it was that long, and then they knew she wanted to go to one Hospital and not the other. She had been loosing words before this happened, but not as bad as this one. This was about the same reaction that she had when she got the COVID virus in January. She was then taken to the hospital where she was given fluids and hydrated her and checked her heart, saw a cardiologist and a neurologist to see if those things caused the fainting and had blood work done. They also did a CAT Scan of her head and neck. They told her that she was fine and was discharged back home after 5 days, which was 3/11/21. Since then she has been very tired, she does have GERD and her stomach has been hurting a lot as well.
68 2021-03-18 heart rate increased Two days after receiving the shot, in addition to soreness at injection site, both my arms and hands... Read more
Two days after receiving the shot, in addition to soreness at injection site, both my arms and hands suddenly started tingling, like pins and needles. That was on Feb. 11th, and now, March 19th I still have tingling everywhere from my neck down to my feet. Mostly arms and legs. It has gotten worse at times, then is milder, I notice it most when I try to fall asleep. The paresthesia keeps me awake or wakes me up. It also makes my heartbeat increase, along with hot flashes. I've been to the ER two times, have taken antihistimines but they do not agree with me. My doctor thinks it's a neuropathic reaction to the virus and will go away but it's been over 5 weeks and is still there. I will see a neurologist soon to rule out other possible causes, but I've never had paresthesia before, so think it must have been the Pfizer vaccine.
68 2021-03-18 lightheadedness Within two hours had headache, violent diarrhea, clammy skin and sweating. Light headed to the point... Read more
Within two hours had headache, violent diarrhea, clammy skin and sweating. Light headed to the point of almost fainting. I called 911 which I never would do normally but there was no one but me and I wasn?t sure what was happening. Medics took vitals and all was ok. By the time they arrived I was shaky but all other symptoms had gone.
68 2021-03-18 blood clot, chest pain multiple blood clots in lungs; multiple blood clots in legs; feeling chest pain; short of breath; Th... Read more
multiple blood clots in lungs; multiple blood clots in legs; feeling chest pain; short of breath; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), via an unspecified route of administration in left arm on 06Feb2021 at 18:00 at single dose for covid-19 immunisation. The relevant medical history included DCIS Breast cancer from 2016, Known allergies: pencillin from an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient previously received first dose of BNT162B2 on 16Jan2021 at the age of 68 years old (lot number: EL3249, at 06:15 PM, in Left arm) for covid-19 immunisation. The patient received 2nd Pfizer vaccine dose on Sat, 06Feb2021. On Wednesday 10Feb2021 she became short of breath. On 11Feb2021, she began feeling chest pain. On 12Feb2021, she was advised by primary care Dr to go to the emergency room. She was admitted on 12Feb2021 to ICU with multiple blood clots in her lungs and legs. She was told by the emergency Dr this was a sign of Covid, they did a Covid test, came back negative. She remained in the hospital till 18Feb2021. She was at the time of the report on Eliquis (10 mg/d). A hereditary blood clot test was done that came back negative. She had never had an issue before the vaccination with blood clots nor anyone in her family and she was in good health before the vaccination. Dr didn't think the vaccine caused the blood clots but her primary care Dr thought it did-which was why she was reporting it. The patient also stated that event multiple blood clots in her lungs and legs resulted in Emergency room/department or urgent care, Hospitalization and Life threatening illness. The patient had hospitalization for 7 days. Treatment Heparin 25,000unit in .45% NaCl Premix, Narcan received. No covid prior vaccination. The patient underwent lab test included Nasal Swab which showed negative on 12Feb2021; Hereditary blood clot test which showed negative on an unspecified date in 2021. Therapeutic measures were taken as a result of all the events. The outcome of the events was recovered with sequel.
68 2021-03-20 chest pain Fever - 101; Muscle aches; Joint aches; Headache; Sinuses hurt; Chest hurt; Tired (All side effects ... Read more
Fever - 101; Muscle aches; Joint aches; Headache; Sinuses hurt; Chest hurt; Tired (All side effects were gone the next day with the exception of fever - I keep running a very low-grade fever 99.5 into day 3) 2nd day after injection - Injection site had redness going down to my elbow, very warm, and felt swollen
68 2021-03-20 chest pain First 48 hours fever 101 degrees, chest pain, aches, chills, unable to sleep due to pain everywhere ... Read more
First 48 hours fever 101 degrees, chest pain, aches, chills, unable to sleep due to pain everywhere Approximately 6 days later severe vertigo.....now still soon 4 weeks later, off and on vertigo mild to moderate. Blood work on 3/10/21 my basophils is high and my mean corpus all hemoglobin concentrate low. Two months before this shot, everything was normal
68 2021-03-20 hypertension patient complained of stabbing pain in left temple at time of departure. BP 176/81 82 16. BP taken... Read more
patient complained of stabbing pain in left temple at time of departure. BP 176/81 82 16. BP taken two times again, 5 minutes apart continue to be 185/ 87. Encouraged to call Primary regarding HTN. No further vaccine reactions noted.
68 2021-03-21 loss of consciousness Blacked out completely while driving home on the highway about 50 minutes after the vaccine was admi... Read more
Blacked out completely while driving home on the highway about 50 minutes after the vaccine was administered with no reactions during the observed waiting period.. After awakening, nauseated, vomiting, woozy, dizzy, felt extremely cold, drained, somewhat unclear. Friend in vehicle was able to get to the steering wheel and we went off road into trees and grass on the side of the road several hundred feet until she was able to stop the vehicle. I did not come to until after the vehicle stopped. First responders came, reports made. Examined and tests done at Emergency room.
68 2021-03-21 chest pain Pain radiating from chest to left side of neck and left arm; Sore Swollen Lymph Nodes; Pain chest; A... Read more
Pain radiating from chest to left side of neck and left arm; Sore Swollen Lymph Nodes; Pain chest; Arm Pain, Left; Can't hardly use her left arm, it is so sore; This is a spontaneous report from a contactable nurse reported for herself. A 68-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9261, via unknown route on 12Feb2021 12:00 (at the age of 68-years-old) at left arm for COVID-19 immunization. The patient had not medical history. Concomitant medications were not reported. Vaccination Facility Type: Hospital. On 12Feb2021 the patient experienced left arm pain, pain chest, can't hardly use her left arm, it is so sore and on 14Feb2021 Pain radiating from chest to left side of neck and Swollen Lymph Nodes. Caller stated that she was thinking needs to go to the Emergency Room because it could be her lymph nodes, a blood clot, or her heart. She stated that she has been experiencing this since day one and nobody else has had side effects but her. She stated that this was out of the ordinary and according to the list she was given, it was not listed as a side effect. She was supposed to go tomorrow to get second shot, but she didn't think that she was going to be able to do it. No emergency room or physician office required. The outcome of the events at the time of last observation was reported as not recovered. Treatment was none. The events were assessed as serious, important medical events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-03-22 fainting PATIENT FELT DIZZY AFTER BEING ADMINISTERED PFIZER DOSE 1 COVID-19. REMAINED FAINT FOR >45 MIN AFTER... Read more
PATIENT FELT DIZZY AFTER BEING ADMINISTERED PFIZER DOSE 1 COVID-19. REMAINED FAINT FOR >45 MIN AFTER WHILE REMAINING SEATED. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO LOCAL ER.
68 2021-03-22 heart rate increased, blood pressure increased initially post vaccine in 1st 10 min. BP sppiked along with heart rate; vision "off". After that all... Read more
initially post vaccine in 1st 10 min. BP sppiked along with heart rate; vision "off". After that all OK until I got up on the 18th. I had right groin "ache". Checked for enlarged Lymph nodes. Couldn't find. Rt hip has been replaced. I did have crown prepped on the 17th March 23h post covid Pfizer. I took Azathioprine 500mg prior to dental appt. The groin discomfort lasted until 3/22/21 night/none arising 3/23/21. Also had left groin and lower back and rt butt cheek discomfort 3/22/21. Of course with the replacement hip (2010) and dental, I am concerned the discomfort on the RHS is hip replacement related nit Covid but Pharmacist suggested I write it up.
68 2021-03-23 palpitations Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101... Read more
Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101.9) Body ache Chills Upset stomach/ no appetite
68 2021-03-23 arrhythmia, atrial fibrillation One week and one day after receiving this first vaccine, I had a 4 hour attack of AFIB. I have suff... Read more
One week and one day after receiving this first vaccine, I had a 4 hour attack of AFIB. I have suffered from rhythm problems (diagnosed as throwing PVC beats) since going through radiation in 1994 for breast cancer treatment, but I have NEVER had anything like what I had in this attack. It was quite a coincidence that it occurred one week after receiving my vaccine. I have been having worsened issues with my arrhythmia ever since, worsened again by my second dose of vaccine.
68 2021-03-23 fainting Was at home, felt Dizziness,fainting,fever,strong headache,fatigue,cold sweat,body ache,clammy skin,... Read more
Was at home, felt Dizziness,fainting,fever,strong headache,fatigue,cold sweat,body ache,clammy skin,nausea, short of breath ,dry mouth ,dehydrated, very bad I though Iwas going to pass out at any time,weak.
68 2021-03-24 platelet count decreased After 1st shot : Platelets down to 140k; splenic discomfort /pain; This is a spontaneous report from... Read more
After 1st shot : Platelets down to 140k; splenic discomfort /pain; This is a spontaneous report from a contactable nurse (patient herself). This 68-year old female patient receive her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number EL 9262, via unspecified route of administration on the left arm on 05Feb2021 at 3:30 PM (at the age of 68-year old) at single dose for COVID-19 immunization. Relevant medical history included allergy to NSAIDs, cephalosporin and bee stings, Epstein-Barr virus infection (EBV), chronic obstructive pulmonary disease (COPD), drug induced immune thrombocytopenia (ITP) with NSAIDs and Rebetrol/Interferon), "T&A", tubal ligation, cholecystectomy and osteoporosis. Concomitant medications included zinc, Vit D3, probiotics and calcium. After first shot, on an unspecified date in Feb2021, the patient experienced platelets down to 140k, (Hx of drug induced ITP), splenic discomfort/pain. No treatment was given to the patient for the events. The outcome was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Platelets decreased cannot be excluded. However, the medical history of drug induced immune thrombocytopenia (ITP) with NSAIDs may provide a plausible alternative explanation for the event. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021264907 same reporter/patient, different dose of COVID-19 vaccine/event
68 2021-03-24 deep vein blood clot Developed DVT blood clots in legs and clots in lungs.; Developed DVT blood clots in legs and clots i... Read more
Developed DVT blood clots in legs and clots in lungs.; Developed DVT blood clots in legs and clots in lungs.; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6198) on 06Mar2021 12:30 PM at left arm for COVID-19 immunisation. Medical history included known allergies: Clindamycin and high blood pressure. Historical vaccine was 1st dose of BNT162B2 (lot number EN6201) on 14Feb2021 01:15 PM at left arm for COVID-19 immunisation. Concomitant drugs included hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), omeprazole, nortriptyline hydrochloride (NORTRIPTYLIN). The patient developed DVT blood clots in legs and clots in lungs on 07Mar2021 08:00 AM. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient was hospitalized for 3 days and received treatment. The patient had computerised tomogram (CAT) scan, ultrasound, echocardiogram. Event outcome was not resolved.
68 2021-03-25 loss of consciousness Awoke approx 6AM. Took daily synthroid went back to sleep woke up feeling nauseous and dizzy went to... Read more
Awoke approx 6AM. Took daily synthroid went back to sleep woke up feeling nauseous and dizzy went to bathroom felt like I needed to sit down next I remember I woke up on the floor with cut over my left eye.
68 2021-03-29 palpitations Within 60 seconds, my heart stated racing, my throat swelled and my tongue grew in size and became l... Read more
Within 60 seconds, my heart stated racing, my throat swelled and my tongue grew in size and became like sandpaper. I had a cold drink with me that I guzzled quickly and forced fluids, taking benadryl. I spiked a temperature to 99.5F within the hour. After that resolved I had 48 hours (still going) of flu like symptoms with temps up to 101.
68 2021-03-29 palpitations pt states that immediately after taking the vax she got light headed and her limbs felt very very he... Read more
pt states that immediately after taking the vax she got light headed and her limbs felt very very heavy. Her BP was up to 192/90. They had her sit to monitor her BP and she became nauseas. She went to the ER. They continued to monitor her BP and she was given IV Benadryl. The heaviness in her limbs lasted many hours. Once her dizziness, heaviness in limbs, and her BP was 141/67 and still coming down she went home. Walking to her vehicle she had the dizziness, heaviness and was light headed again. When she got home she went to bed. Pt woke up having heart palpations. No chest pain or SOB. These palpitations lasted about 15 minutes. On 3/30/2021 she has some fatigue and a tightness around the top of her head. Pt has a FU appt w/ PCP on 3/31/2021.
68 2021-03-30 hypertension Somnolence; Dizziness; Imbalance; High blood pressure; This is a spontaneous report received from co... Read more
Somnolence; Dizziness; Imbalance; High blood pressure; This is a spontaneous report received from contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. E19266) single dose, in the left arm, on 20Feb2021, for COVID-19 immunisation. Relevant medical history included penicillin allergy, aortic valve replacement and diabetes. The patient previously, on 30Jan2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. E105318) single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 20Feb2021, the patient experienced somnolence, dizziness, imbalance and high blood pressure. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious. Post the vaccination, the patient has not been tested for COVID-19. Futher information has been requested.
68 2021-03-30 hypertension, blood pressure decreased, chest discomfort blood pressure was checked and it had skyrocketed to 204/110; blood pressure had dropped to 95/58; s... Read more
blood pressure was checked and it had skyrocketed to 204/110; blood pressure had dropped to 95/58; she was lightheaded; feel chest pressure; facial flushing and warmth; facial flushing and warmth; redness on her neck and chest; This is a spontaneous report from a contactable retired registered nurse (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right deltoid on 06Mar2021 10:09 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for anaphylaxis prophylaxis; famotidine (PEPCID) taken for anaphylaxis prophylaxis; cetirizine hydrochloride (ZYRTEC) taken for anaphylaxis prophylaxis; methylprednisolone acetate (MEDROL) taken for anaphylaxis prophylaxis. The patient previously received H1N1 vaccine (Sanofi Pasteur, lot number: UP006AA, expiry date: 15Mar2011) on 27Oct2009 and experienced anaphylaxis. Patient had no other vaccines on the same day as the suspect product. The patient experienced blood pressure was checked and it had skyrocketed to 204/110 (hospitalization (from 06Mar2021 to 08Mar2021)) on 06Mar2021, felt chest pressure on 06Mar2021 10:29, facial flushing and warmth on 06Mar2021 10:29, redness on her neck and chest on 06Mar2021 10:29, she was lightheaded on 08Mar2021, blood pressure had dropped to 95/58 on 08Mar2021 21:43. Clinical course: Caller states that she received her first dose of the product on 06Mar at 10:09am. Caller states that to provide some history, in Oct2009, she had anaphylaxis from the H1N1 Vaccine and in 2017, she finally found an allergist who specialized in medication allergies. Caller states that since then, any time she takes the Flu Vaccine, she pre medicates with a combination of antihistamines and a proton pump inhibitor. Caller states that in preparation of the COVID vaccine, her allergist prescribed her a Medro Dose pack and antihistamines and a proton pump inhibitor for preparation, starting three days prior to the vaccine, in order to prevent anaphylaxis. Caller states that 20 minutes post receiving the vaccine, she started to feel chest pressure, she had facial flushing and warmth, and redness on her neck and chest. Caller states that her blood pressure was checked and it had skyrocketed to 204/110. Caller states that she did not have anaphylaxis though. Caller reports that with her blood pressure being so high, they had to call paramedics, and the caller went via ambulance to the ER at about 1130am on 06Mar2021. Caller states that she spent 6 hours in the ER, and then she was put in the hospital for the next two days. Caller reports she was admitted to the hospital for her blood pressure because the ER could not get it below 185 systolic. Caller states that all her labs were negative for everything, and they checked heart attack markers that were all negative. Caller had an EKG and a stress test and those were both negative as well. Caller had blood work done, EKG and stress test that were all normal. But caller states that it took a while to get her blood pressure down. Caller states that she was talking with her allergist and he said that if she gets the second dose of the vaccine, it would need to be in a hospital setting, with an IV already in place, and caller does not think insurance will cover all that. Caller states that she did speak with an Infectious Disease doctor, who told the caller that she needs to get the second dose of the product for COVID coverage, but how would the caller move forward with getting the second dose, following what happened to her? Caller is wondering how much protection the vaccine provides after just one dose? Caller is also wondering, the hospital gave her at least two or three doses of Solu-Medrol, and caller is wondering if having received steroids in the hospital would reduce the efficacy of the COVID vaccine, and if so, by how much? Event Details: Caller had the vaccine, and the reaction started on 06Mar2021, and she was admitted on the same day. Caller was discharged from the hospital on 08Mar2021 around 330pm. Caller reports that the morning of her discharge from the hospital, her blood pressure had gotten back to 135 systolic, but before it was time for her to go down for the stress test, it was back to 159, and down while she was in nuclear medicine, it got to 160 systolic. Caller reports that the day she was discharged, she went home and got settled in, and she took her blood pressure and it was down to 128/78, but then that evening, things got spinning around her, and lights were flickering in her head, and she was lightheaded, and her blood pressure was 110/63 at 9pm and by 9:43pm, her blood pressure had dropped to 95/58. Caller states that it has not been a fun trip. Caller reports that the next morning, her blood pressure was back up to 139/78, but then later in the day she was lightheaded again, and by 9am her blood pressure was 111/69. Caller states that since then, her systolic blood pressure has been between 110 and 126. Caller states that there is nothing else she can think of. Caller states that she felt fine the morning of getting the COVID vaccine, she was looking forward to getting it, and she got herself on the list and made sure to consult with her allergist so that she would have prophylactic medications ready to go. Caller states that she does have a history of hypertension, but her blood pressure was 128/72 the morning of getting the COVID vaccine. The outcome of the events Blood pressure high and Blood pressure dropped was recovering, of the other events was unknown. The reporter considered the event blood pressure had skyrocketed to 204/110 was related to the suspect vaccine.; Sender's Comments: Based on the temporal association and known drug safety profile, a possible contributory role of vaccination with BNT162B2 to the reported event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
68 2021-03-30 loss of consciousness sepsis; gallbladder attack; passed out from the gallbladder attack; Gets dizzy; Weakness; she was tr... Read more
sepsis; gallbladder attack; passed out from the gallbladder attack; Gets dizzy; Weakness; she was trying to gain her strength from being sick; her head hurt from the fall; her head hurt from the fall; she had to walk slower because she got dizzy; This is a spontaneous report from Pfizer. A 68-year-old female contactable consumer reporting for herself received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6200, expiry date Jun2021) on 16Feb2021 at 14:45, in left arm, for COVID-19 immunisation. The patient received the COVID-19 vaccine for age and several comorbidities. No other vaccines were administered within 4 weeks. Medical history included ongoing high blood pressure diagnosed 25 years ago, ongoing hypothyroidism diagnosed 25 years ago, liver resection in 2007 for a benign tumor (she had not been sick and it was found accidentally), liver bile duct stopped up from 2017 and ongoing (due to scar tissue from the liver resection surgery; she had an emergency stent placed in her bile duct), chronic Crohn's disease, ongoing thyroid disorder. The patient previously received flu vaccines on unspecified dates for immunization experiencing unspecified side effects some years ago, but this past year she didn't have a reaction. The patient previously received pneumonia shots on unspecified dates since few years. Family history included gallbladder problems in her sisters and mother. Concomitant medications included oral amlodipine (manufacturer: Lupin, expiry date: 23Feb2022) from an unspecified date (a few years ago) and ongoing, 5 mg at night, for blood pressure, oral telmisartan (MICARDIS; manufacturer: Alembic, expiry date: 02Mar2022) from an unspecified date (few years ago) and ongoing, 80 mg at night, for blood pressure, oral metoprolol (manufacturer: Mylan, expiry date: 09Feb2022), from an unspecified date (few years ago) and ongoing, 25 mg twice daily, morning and night, for blood pressure, oral levothyroxine sodium (SYNTHROID) from an unspecified date (20 years ago or more), 75 ug daily in morning, with water, hour before any eating or other medications, for thyroid disorder. The patient experienced sepsis on 25Feb2021 with outcome of recovered on 03Mar2021, gallbladder attack on 24Feb2021 with outcome of recovering, passed out from the gallbladder attack on an unspecified date in 2021 with outcome of unknown, got dizzy on an unspecified date in 2021 with outcome of not recovered, weakness from being hospitalized on an unspecified date in 2021 with outcome of not recovered, she was trying to gain her strength from being sick on an unspecified date in 2021 with outcome of unknown, her head hurt from the fall on an unspecified date with outcome of unknown. The patient was hospitalized for sepsis due to a gallbladder attack from 25Feb2021 to 03Mar2021. The events gallbladder attack and sepsis required also an ER visit. They did not require a physician office visit. Additional clinical course of the events included the following details. Gallbladder attack turned into infection/sepsis quickly. She previously had an emergency stent placed in her bile duct and now there was a stone in the bile duct and she was unsure if it was related; they will either remove her gallbladder or place a permanent stent. They removed stones and "goop" and placed a stent. Her gallbladder still needed to be operated on, but she was not sick with sepsis anymore. Regarding gallbladder attack the patient reported that it was controlled until further tests and surgery were performed. They couldn't do the surgery due to the infection which had cleared up but she did not want the surgery right now. A stent was placed in the duct until something was done and the stone will be crushed eventually. The patient passed out from the gallbladder attack. She never passed out, she had only ever passed out one other time in her 20's where she stood up too fast. The patient reported that she had to walk slower because she got dizzy and she was trying to adjust to getting home. She walked to the bathroom, used it, and her husband heard a thump while he was using the other bathroom. She was looking at the thermostat and fell in the den and she was surprised she didn't hit anything. Her head hurt from the fall. Sepsis: caller reported that as soon as she went to the ER, she was diagnosed with sepsis. Sepsis resolved the day she was discharged from hospital and when she was dismissed all tests were negative for sepsis. She went home on antibiotics for security for another week after discharge from hospital. Dizzy: it was just trying to get her strength up. She'll just be doing nothing and getting up too fast, it happened to any old person with blood pressure medicines. Dizziness began before she went into the hospital. She was experiencing weakness from being hospitalized and she was trying to gain her strength from being sick. Weakness began during her hospital admission and it was ongoing. On 03Mar2021 the patient underwent lab tests and procedures which included haematocrit: 30.4 %, haemoglobin: 10.4 g/dl (not in normal range yet), CMP: within normal limits (all results were within normal limits, including sodium and potassium), platelet count: 159, RBC count: 3.33 (supposed to be 3.9 or more but could have gotten better by now), WBC: 6.1 x10?/L, blood cultures: the results were not yet listed but sepsis was gone according to discharge blood work. She went to the doctor regularly. Her doctor knew how sensitive that was with her, but that her side effects were probably no more than anyone that experienced that. In some years she did not experience adverse events, specifically she did not with her flu vaccine in 2020. She has had side effects that had made her feel ill for 2-3 days and her niece was a nurse and thought she was making it up. The patient was advised to wait for the 2nd dose, she was unable to get it as scheduled on 08Mar2021. In meantime between receiving her first dose and her appointment for her second dose on 08Mar2021, she was hospitalized. The patient was just coming out of the hospital before 08Mar2021 and she still did not feel well so she cancelled the appointment. The hospital doctors, as well as the doctors approaching more tests with her gallbladder, recommended to not get the second dose as scheduled on 08Mar2021, but they could not recommend how or when to get it.
68 2021-04-01 pulmonary embolism, chest pain 3/6/21-About two in a half days following the 2nd dose, patient had sudden onset of right sided ches... Read more
3/6/21-About two in a half days following the 2nd dose, patient had sudden onset of right sided chest pain, pleuritic, lasted several days- did not seek attention. 3/17/21- Sudden onset of severe left sided pleuritic chest pain and dyspnea. Presented to ER, found to have extensive Bilateral Pulmonary Emboli. 3/17/21- Patient admitted to Hospital. Initially put on anticoagulation, but due to GI bleeding had placement of Inferior Vena Cava Filter. 3/23/21- Discharged from Hospital.
68 2021-04-01 palpitations, fast heart rate This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient receiv... Read more
This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot # EN6201), via intramuscular (IM) injection left deltoid on 13Feb2021 08:40 as single dose for covid-19 immunisation. Medical history included respiratory issues. Concomitant medications were not reported. The patient experienced her heart rate started increase/tachycardia on 13Feb2021, she felt her heart pounding and she felt very ill on an unknown date in Feb2021. The report received as, caller states that she had her first COVID vaccine at about 8:40 AM on Saturday morning 13Feb2021. Caller started a guided meditation at 2 pm that day and at 2:05 pm, the caller became aware of her heartbeat. Caller states that her watch told her that her heartbeat was in the 90s, and after a bit it went into the 100s and then 110s, then 120s then 130s then 140s and by 4pm, the caller's heartbeat was in the 160s and the highest she calculated was 168. Caller states that when her heartrate was in the 150s and 160s, she was feeling like her heart was pounding in her chest like it was going to break through, and she felt very ill. She felt badly. Caller states that she called her friend to come over and take her to the ER, but her friend ended up leaving about 6pm because the caller's heartrate was back down to about 145. Caller did not end up going to the ER. Caller states that as the evening progressed, her heartrate ranged from the 90s to the 100s (103, 104). Yesterday it was back to normal and her heartrate was back in the 70s all day and she felt fine. Caller states that she had tried deep breathing and relaxation techniques and nothing worked to bring her heart rate down. Normally, if she gets stressed she deep breathes. She contacted her primary care provider by email and they sent the chart to allergist to help and said if her heart rate went above 110 to go to the emergency room. The caller asked if she should receive her second dose. Caller states that she was scared during the event, so she did contact (Health care company name), and they told the caller that she should have gone to the hospital. Caller states that (Health care company name) told the caller that the caller may not get the tachycardia from the second dose, but that the caller needs to let the nurses know about her side effect to the first dose. Caller was also informed by (Health care company name) that if the caller's heartrate goes above 110, the caller should go the ER. Patient weight provides as her weight as between 120 and 121 pounds. Event details was provided as, caller states that she did try to call Pfizer on Sunday and she left a message, but no one got back to her, and she wanted to ensure this was reported. Caller states that by Sunday she was fine. Caller started having tachycardia Saturday afternoon and it lasted into the evening. Caller states that by Sunday evening she was running in the 90s-100s but staying under 105, but she woke up fine on Sunday. Seriousness was reported as, caller states that it was very serious, and she should have gone to the ER but she didn't. Suspect Product and Indication details was provided as, caller reports that she got the product for COVID Prevention and because she has respiratory issues, but no further details were provided by the caller. Caller confirms that she received no other vaccines on the same day as the COVID vaccine. Concomitant Medications, History and Investigations was reported as, caller states no to these questions. Caller states that in fact, she just had millions of lab tests and everything was fine and being that she was relaxing in a meditation when it started, caller is sure it was from the vaccine. Caller states that she tried deep breathing and relaxation techniques and this tachycardia was happening, and she could not control it. The patient underwent lab tests and procedures which included on 13Feb2021, heart rate was 160 seconds, increase throughout the day /heartbeat was in the 90s, and after a bit it went into the 100s and then 110s, then 120s then 130s then 140s, 168 seconds, highest she calculated, 145 seconds at 6:00 PM the average was down /heartrate ranged from the 90s to the 100s, on 15Feb 2021, heart rate was 70 seconds on 15Feb2021 heartrate was back /all day and she felt fine, pulse: ranged from 90 to lower 100s (103, 104) on 13Feb2021 (as the evening progressed), and normal on 15Feb2021, lab test: fine on an unknown date. The outcome of the event Her heart rate started to increase/Tachycardia was recovered on 14Feb2021 and remaining events was unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the event her heart rate started increase/tachycardia and the usage of the vaccine BNT162B2 cannot be excluded because of temporal association. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
68 2021-04-05 fainting had a syncopal episode and fell after receiving vaccine
68 2021-04-06 fainting Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vo... Read more
Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vomitting fever severe trembling and chills. During the night nightmares and migraine woke me up. Tried to go to the bathroom but collapsed and knocked my head on the wall. Could not get up crawled to the bathroom and tried to pull myself up but fell headfirst and hit my nose and cheek on the toilet. Cut nose and hurt cheek bone. Felt terrible head spinning and unable to get up/ Crawled to bed; Live alone. Could not even find the telephone; Woke up and tried to get up. Freezing cold. Finally called Ambulance Their doctor refused to send an ambulance and said " go to your GP its not an emergency". I was disgusted barely could walk but somehow drove to the GP. he was closed so went to emergency. the Dr in charge of the vaccination center was there but did not accept it was the vaccine; Finally on the verge of collapse another lady took me to the entrance of emergency. I was finally seen:; Same thing. Dr there told me its not an emergency and to go and see my GP. I was so sick and told him th eGP was not there; His reply " There are plenty of others to see" It was the nurse who persisted and even thought may be I had covid and did the PCR test. I started uncontrollably shivering and was freezing. I had a fever. they did blood tests lung x ray and finally a urine test, Full of blood leucocytes and protein. The same wonderful nurse said its bad. I was by then vomitting again and thought I would die; Uncontrollable shivering ; taken to the lab or a pelvic cat scan;Couldnt even get to sip water. SEVEN hours later the same DR who told me I was not an emergency came in and said " You will have to be hospitalised as you have a serious kidney infection. Acute pyelonephritis. I vomitted on him! Taken to a ward 25 March until 29 March. Rocephin antibiotics. Allergy to that too with migraines and skin rash; They changed the antibiotics. After five horrible days I finally went home on antibiotics Ofloxacine
68 2021-04-06 blood pressure increased, heart rate increased pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a s... Read more
pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 11:20 (at the age of 68-years) as single dose for COVID-19 immunization. Medical history included multiple allergies. There were no concomitant medications reported. Her cousin had a similar reaction to flu vaccine. On 20Mar2021, The patient experienced pulse went up, blood pressure was elevated, very tired and fatigue on 20Mar2021.On 22march, the experienced itchy all over her body. The patient was hospitalized for pulse went up from 20Mar2021 to 21Mar2021. The other events (blood pressure elevated, tired/fatigue, itchy) were reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: it was 132/86 on 20Mar2021. At 18:15 pm elevated to 146/91, heart rate: pulse went up to 125 and stayed up for many hours on 20Mar2021 pulse of 118, at 18:15 pm pulse of 153. Therapeutic measures were taken as a result of pulse went up. The outcome of increased heart rate was recovered, elevated blood pressure and pruritus was recovering and fatigue was not recovered Additional information on lot/batch number has been requested.; Sender's Comments: Based on the information currently available and plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events pulse went up, blood pressure was elevated, very tired and fatigue, and itchy all over her body cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
68 2021-04-08 hypertension my blood pressure was 199/91; little Dizzy; eyesight blurry; This is a spontaneous report from a con... Read more
my blood pressure was 199/91; little Dizzy; eyesight blurry; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 11Feb2021 13:00 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included blood pressure, cholesterol, arthritis, glaucoma, non-allergic rhinitis. Concomitant medications included lisinopril at 40 mg, atorvastatin calcium at 20mg, paracetamol (TYLENOL) at 500 mg all taken for unspecified indication. It was reported that 10 minutes after the shot patient got a little dizzy, eyesight blurry, the nurse put me on a bed and my blood pressure was 199/91. Patient stayed in bed 20-30 minutes till blood pressure went down to 136/75. Case consider as serious with seriousness criteria as medically significant. Outcome of the events was recovered on unspecified date in 2021.
68 2021-04-12 skin turning blue had swelling and pain in her wrist; had swelling and pain in her wrist; her fingers turned a deep bl... Read more
had swelling and pain in her wrist; had swelling and pain in her wrist; her fingers turned a deep blue; caller was given some medication to dilate her blood vessels; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on right arm on 17Mar2021 17:00 (Batch/Lot Number: EN6206) at single dose (at the age of 68 years old) for COVID-19 immunisation. The patient had no medical history. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. On 19Mar2021, the patient had swelling and pain in her left wrist, the following day her fingers turned a deep blue. The patient was sent to the hospital to rule out a blood clot, they couldn't find a clot and couldn't tell the patient if this was related to the vaccine. The patient was given some medication to dilate her blood vessels to take when the patient gets the second if she needs it. This happened in the opposite arm that the caller received the vaccine. The patient had an angiogram of the wrist on 21Mar2021, they injected dye into the patient's wrist then she went through the CT scan on 20Mar2021 and the results were negative. The patient was hospitalized on 20Mar2021 to 22Mar2021. The outcome of her fingers turned a deep blue recovered on 22Mar2021 and other events was recovered on Mar2021.
68 2021-04-14 low blood platelet count, platelet count decreased Covid Vaccine related ITP.......red pinpont rash on both legs, blood blisters on lips, tongue, gums ... Read more
Covid Vaccine related ITP.......red pinpont rash on both legs, blood blisters on lips, tongue, gums and roof of mouth, blood streaks and bruises all over body, platelets dropped to 0 more than once. I was in Urgent Care, 2 ER's and hospitalized from March 14-24, 2021. I was given 84 bottles of immunoglobulin intravenously and high potency steroids (90 mg., 80 mg.). This did not bring my platelets up so our daughter contacted the wife of the physician who passed from this after his vaccine who in turn gave our daughter the name of another physician who had seen and treated this after the Covid vaccine. He,together with my physicians, came up with an aggressive treatment plan for me. I was given one Vincristine treatment and injections of Nplates to jumpstart my body. This had never before been seen where I was located, as the Covid vaccine is so new. I was a perfectly healthy woman who only took vitamins and had not even had a cold all winter. Everything else was ruled out.
68 2021-04-17 oxygen saturation decreased, fainting, heart rate abnormal 19 second pause of no heartbeat and in third degree heart block; 19 second pause of no heartbeat and... Read more
19 second pause of no heartbeat and in third degree heart block; 19 second pause of no heartbeat and in third degree heart block; Awoke to throw up; Thinks she fainted; Oxygen level of 93 on oximeter; she wasn't feeling well; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Mar2021 at 15:00 (Lot Number: EN6198) as single dose for covid-19 immunization. Medical history included mild stroke from 18Jan2020 and not ongoing, suspected she had atrial fibrillation and she had a heart monitor placed 21Feb2020. Her heart monitor never showed Atrial Fibrillation after one year of being monitored. Ongoing low thyroid/hypothyroidism and blood cholesterol increased from an unknown date. Concomitant medications included levothyroxine taken for low thyroid/hypothyroidism from an unspecified start date (started probably been 10 years) and ongoing; atorvastatin taken for reduce cholesterol from 2020 (started right after she had stroke, either Jan2020 or Feb2020) and ongoing. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 01Mar2021 (at age of 68 years old, Lot Number: EN6200) as single dose for covid-19 immunization. She was fine right after the first dose. She only had a sore arm for 3 days. Just last week, she had a severe adverse reaction right after her vaccine. With the second dose, she had everything possible. Twelve hours after, on 23Mar2021 at 03:00, she awoke to throw up. She thinks she fainted. She had to throw up 2 more times that night. She had been wearing a heart monitor. On 24Mar2021 her cardiologist called her and told her she had a 19 second pause of no heartbeat and was in a 3rd degree heart block. The very next morning, they put in a pacemaker. She was overall healthy and athletic. She was a runner and golfs all the time. She had an outpatient procedure for the pacemaker placement at the hospital on 25Mar2021. She was still recovering but improving. Caller added it was scary when your heart stops. Caller added she did not see this as a possible related side effect, but that evening when she was not feeling well, 22Mar2021, she checked her oxygen level with her oximeter. It was 93 and usually runs around 99. It is back to normal now. She checked it the night she was vomiting. Stated this was before the third degree heart block by a few hours. She did not think it was related. All her symptoms are gone other than the placement of her pacemaker. The outcome of the events " 19 second pause of no heartbeat and in third degree heart block" was recovering. The outcome of the event " Oxygen saturation decreased" was recovered. The outcome of other events was unknown.
68 2021-04-17 blood pressure increased, palpitations feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head ... Read more
feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head feels tight, like there is a band around it/head feels tight, like there is a band around it; Nausea; severely lightheaded; her limbs felt heavy; her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86; it was hard to lift her arms; This is a spontaneous report received from a contactable two nurses (one nurse reported for herself). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205 and expiration date: 30Jun2021), via an unspecified route of administration right arm on 29Mar2021 at 10:15 as single dose for COVID-19 immunization. Medical history included anaphylaxis (recovering), hypertension ongoing, gastroesophageal reflux disease (GERD), anemia (her hemoglobin dropped to 6.9 and ferritin was low), hiatal hernia surgery (had mesh), a latex allergy (her lips would start swelling) and food allergy (tuna fish). Family history included lung disease (her dad was diagnosed). Concomitant medications included hydrochlorothiazide (HCTZ) 25 mg, daily (been on it for 10 years) taken for high blood pressure from an unspecified start date and ongoing; losartan 100 mg, daily (for about 10 years) taken for hypertension from an unspecified start date and ongoing; iron (Tablet) 65 mg, daily (about 10 years ) taken for anaemia, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication; The patient previously took cefalexin (KEFLEX) and experienced swelling on face and mouth, epipen, acetylsalicylic acid (ASPIRIN) (6 years ago aspirin sensitivity took place) and experienced haematuria, tolectin as nonsteroidal anti-inflammatory drug (NSAIDS) (about 30 years ago (received steroids, breathing treatments and benadryl) and experienced anaphylactic reaction, flu vaccine taken for flu (at 19 years old). The patient got first vaccine on 29Mar2021 and had an event. On the same day, she was severely light headed and her limbs felt heavy and her blood pressure went way up and lasted a good 7 hours. They had her in the emergency room. She did have palpitations overnight that woke her up in her sleep for 15 minutes but she had no chest pain or shortness of breath and then it went away. At first, she didn't feel anything, but then as soon as she got up to go to the sitting area where she was supposed to wait for 15 minutes, she became very very light headed, almost like there was a band around your head. there was no dizziness, but she was lightheaded and all four of her limbs felt really heavy, it was hard for her to move her limbs, she experienced nausea while sitting in the waiting area as well. She did not throw up and it started about an hour after the vaccine and describes the nausea as fleeting and states it lasted about a couple of hours, but not as long as the light headedness and heavy limbs. her blood pressure at this time was elevated to 190/86. the doctor there told them to send her to the ER. The reporter stated that the vaccine was given at the hospital, so they just wheeled her to the emergency department within the hospital, the doctor in the emergency room told her they didn't think it was an allergic reaction. after about 6 hours around 1600 her blood pressure finally came down to 141/67. She was discharged from the emergency room around 16:00 on 29Mar2021. At the time of discharge, the heaviness of limbs and light headedness had went away, but when she was walking to get to her car in the parking lot the lightheadedness and heaviness of her limbs returned. it was hard to lift her arms. she went home and went to bed, the lightheadedness and heaviness of her limbs went away after she was able to lay down and rest. Last night around 2:30 or 3:00am she woke up with heart palpitations. Caller states that these palpitations went away after 15 min and that she hasn't had this experience in years since hiatal hernia surgery. she felt much better next day, the only thing she felt today was tightness in her head but not a headache and just felt tired. The outcome of the events severely lightheaded, her limbs felt heavy, her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86 and head feels tight, like there is a band around it were recovered in 2021; nausea was recovered on 29Mar2021; palpitations was recovered on 30Mar2021 and other events were unknown. As reported causality : Feeling light headed; Limbs felt really heavy; high blood pressure Related; head feels tight, like there is a band around it; heart palpatations Related. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect COVID19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
68 2021-04-18 palpitations 01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21 4 days later I e... Read more
01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21 4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
68 2021-04-18 fibrin d dimer increased, pulmonary embolism The patient developed shortness of breath with activity. The following day she spoke with me, her pr... Read more
The patient developed shortness of breath with activity. The following day she spoke with me, her primary care provider, and I sent her to ER whereby she was found to have submassive pulmonary embolism.
68 2021-04-19 palpitations A few days after my shot I started feeling very tired and groggy. My head was dizzy most of the day... Read more
A few days after my shot I started feeling very tired and groggy. My head was dizzy most of the day. Five days after the vaccination I started to go into a sweat if I exerted myself too much. I continued to have a dizzy head and my stamina was greatly reduced. I used to ride my exercise bike for 90 -150 minutes a day but after the vaccine I could only go 20 minutes the first week and then I got progressively weaker and more dizzy. I could barely walk a half block. I also experienced some shortness of breath and a racing heart at times. The third week out was the worse. I could hardly care for myself. I started to get a lot of pain behind my eyes and other sinus pressure. Also the lymph gland under my ear was swollen and painful. I was extremely tired for a couple of days at that point but have found it hard to sleep on most other nights. I have strange dreams that are almost like an hallucination. I also have head aches but they seem to have improved as the weeks have gone by, especially since I have been taking Aleve every day. I am unable to exercise and have very little energy still. The dizzy head continues to persist even 6 weeks out. I had this same kind of dizzy head in August when I had Covid but it went away in a week or two. I get dizzy just reading a book or looking at my piano music also. Having had Covid twice I am very confident that these symptoms were caused by this vaccination. It also seemed to make my blood sugar more volatile. The sad thing is that I was feeling perfectly normal when I went in! I am devastated by these symptoms and they have completely altered my life. I am so discouraged that they never go away. Some days I feel like I am improving and then they pop up again. I was a very active person and now I can hardly do anything. I think I got the shot too close to when I had covid and that it has triggered an immune response that is overwhelming my body. Will it ever get better? I can't stand to go on like this!
68 2021-04-19 pulmonary embolism, chest pain Client reported shortness of breath and chest pain 2 weeks after receiving second Pfizer COID vaccin... Read more
Client reported shortness of breath and chest pain 2 weeks after receiving second Pfizer COID vaccine. She was transported to the hospital and received an EKG and a CT Scan of the chest. Patient reported that the scan showed lareg blood clots in both lungs. She reports that she was given high dose TPA and admitted to the ICU. Per client she had ultrasound of legs, arms, and groin which was negative. She is currently taking Eliquis and was discharged from the hospital on 4/6/2021. #Hospital for 3 days
68 2021-04-20 pulmonary embolism, cardiac arrest, atrial fibrillation Acute pulmonary embolism; cardiac arrest; atrial fibrillation with rvr; pulmonary infiltrate right u... Read more
Acute pulmonary embolism; cardiac arrest; atrial fibrillation with rvr; pulmonary infiltrate right upper lobe; hyperglycemia; This is a spontaneous report from a contactable Nurse (patient herself). A 68-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 22Dec2020 11:45 (Batch/Lot Number: EH9899) as SINGLE DOSE for covid-19 immunisation at a hospital, at 68 years old. Patient is not pregnant. Medical history included hypothyroid from an unknown date. Patient has no COVID prior vaccination and has not tested for COVID post vaccination. Patient has no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced acute pulmonary embolism, cardiac arrest, atrial fibrillation with rvr, pulmonary infiltrate right upper lobe, hyperglycemia on 21Feb2021 05:00 which required Emergency room/department or urgent care. The patient was hospitalized (unspecified date) due to the events for 4 days. Therapeutic measures were taken included cardioversion twice and embolectomy. Outcome of the events was recovered with sequelae (with lasting effects) on an unspecified date. Seriousness criteria was hospitalization and life-threatening.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
68 2021-04-20 low blood oxigenation, hypotension, very slow heart rate, cardiac arrest Received 2nd COVID vaccine on 4/19/21. Apparently hadn't been feeling well since. Presented to the... Read more
Received 2nd COVID vaccine on 4/19/21. Apparently hadn't been feeling well since. Presented to the ED on 4/21/21 with hypotension, bradycardia, hypoxia and a GCS of 3. Does have a history of ESRD on HD, but no missed dialysis sessions. Found to have a potassium of 8.7. There was concern for pulmonary embolism but was not hemodynamically stable enough to undergo imaging. Went into PEA arrest x 3 in the ED and ultimately died. Of note, patient did have a recent ankle fracture recently and apparently has been non-ambulatory for at least the past few days.
68 2021-04-23 heart rate increased, blood pressure increased Increased blood pressure/Blood pressure was high/Blood pressure went up to 176/102; High heart rate/... Read more
Increased blood pressure/Blood pressure was high/Blood pressure went up to 176/102; High heart rate/Heart rate went up to 122; Mild rash; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# EL9269), via an unspecified route of administration on 30Jan2021 (at the age of 68-years-old) as single dose for COVID-19 immunisation. Medical history included ongoing hypertension, connective tissue disorder. Concomitant medication(s) included TRIAM HCTZ, amlodipine, hydroxychloroquine, cyclobenzaprine, KLOR-CON (It's Potassium CLCRWM Tablet). On 30Jan2021 (Monday, same day of vaccination), patient experienced increased blood pressure/blood pressure was high/blood pressure went up to 176/102, high heart rate/heart rate went up to 122, mild rash. Patient went to EMT and tested for vitals. And that's when blood pressure and heart rate were found to be high. Therapeutic measures were taken as a result of events included Benadryl. The patient underwent lab tests which included blood pressure: increased/high/went up to 176/102 and heart rate: high/went up to 122 on 30Jan2021. Patient was just leery of taking the Pfizer for second shot because of the problem the high blood pressure and the heartbeat and would like to find out if she can for second shot and can get another vaccination. The outcome of the events was unknown.
68 2021-04-24 palpitations, cardiac arrhythmia, chest pain, heart rate irregular, fibrin d dimer increased chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any ... Read more
chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any Cardiac history; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; irregular heart rate and am going to have to more cardiac work up; extreme shortness of breath with minimal exertion; weakness; dizziness; very tired; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:15 (at 68 years old, not pregnant), single dose for covid-19 immunisation. Medical history included hypothyroidism, arthritis, all from an unknown date. The patient had her first dose of bnt162b2 for Covid-19 Immunization on Mar2021. The patient was taking unspecified concomitant medicines. The patient experienced within 5 minutes after receiving her second injection, she began having chest pain and palpitations. The paramedics ran a 4 lead EKG and she was experiencing consistent PVC's which is abnormal because she does not have any Cardiac history. She went to the emergency room and was noted to have a D-Dimer lab result of 758ng/ml as well as other abnormal labs. Still continue having PVC's and irregular heart rate and was going to have to more cardiac work up. Also have experienced other symptoms associated with actual COVID such as extreme shortness of breath with minimal exertion, weakness, dizziness, very tired. And muscle aches 2 days as of Friday 09Apr2021. All the events also reported as started 07Apr2021 14:15. The outcome of the events was not recovered. Treatment for the events was observation and medication. Patient was hospitalized due to the events for 1 day. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.
68 2021-04-24 cerebrovascular accident stroke; R sided weakness; expressive aphagia; This is a spontaneous report from a contactable other ... Read more
stroke; R sided weakness; expressive aphagia; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 05Feb2021 (at age of 68 years old, no pregnant, Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included type 1 diabetes, hypertension (HTN). The patient not had COVID prior vaccination also not had COVID tested post vaccination. No known allergies. Concomitant medication included insulin, lisinopril and Multi vitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Jan2021 at 03:00 P.M. (at age of 68 years old, Batch/Lot number unknown) as single dose for covid-19 immunization. The patient received 2nd Covid shot on 05Feb2021. Had a stroke on 14Feb2021 at 08:00 AM with R sided weakness and expressive aphagia. Stroke noted on MRI in L hemisphere, speech area. The patient had no idea if this was related to the Pfizer Covid vaccine. AE resulted in: Emergency room/department or urgent care, Hospitalization (1 day), Life threatening illness (immediate risk of death from the event). Treatment received for events included observation, Lovenox. The outcome of the events was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Stroke, Weakness left or right side, and Expressive aphasia cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
68 2021-04-27 chest pain, chest discomfort Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest;... Read more
Asthma flare up; dry, hacky cough; pain and tightness in her chest; pain and tightness in her chest; nausea feeling in her chest; She gets this laryngitis; has trouble talking; She wants to make sure its not going into like a viral pneumonia; Flu-like symptoms; fever; achy; fatigue; Sore arm; Headache; This is a spontaneous report received from a contactable pharmacist (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: CER230) via an unspecified route of administration on 24Mar2021 at 11:30 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 immunisation. The medical history included flu and suspected COVID-19 both in Jan2020 to an unspecified date (she had a bad flu back in Jan2020, which could have been COVID because it was such a bad flu, over a year ago), ongoing asthma from an unspecified date (mild asthma) and chest nausea in Jan2020 to an unspecified date. The patient had no history of any adverse events following prior vaccinations. Medical history (including any illness at time of vaccination) was also reported as none. Family medical history relevant to the adverse event included an uncle that had asthma, but no one else had breathing issues. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR) and ipratropium bromide/salbutamol sulfate (DUONEB), both ongoing and taken for asthma on unspecified dates. Other products were also reported as "no". The patient did not receive any prior vaccinations within 4 weeks prior to the COVID-19 vaccine and did not receive any additional vaccines on the same date as the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: 3N6202) via an unspecified route of administration on 24Feb2021 at 11:30 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunisation. On 24Mar2021 the patient experienced sore arm and headache; on 25Mar2021 the patient experienced flu-like symptoms, fever, achy, fatigue; on 02Apr2021 the patient experienced asthma flare up, dry, hacky cough, pain and tightness in her chest, nausea feeling in her chest; on unspecified dates in Apr2021 the patient experienced she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia. The reporter classified the events headache and flu-like symptoms as non-serious. The patient called to report that she had an asthma flare up 10 days (as reported) after her second dose of COVID-19 vaccine on 24Mar2021. The patient stated that she did not get a flare up often, she had mild asthma. She usually got mild flare-ups since she did not have severe asthma. She stated it could be something else, but she had not had a flare-up like this since she had a bad flu back in Jan2020, which could have been COVID-19 because it was such a bad flu. That was over a year ago. She received her second vaccine on 24Mar2021, and the asthma flare up and hacking cough started on 02Apr2021. On the night of 24Mar2021, she started with a headache. She had the shot at 11 something and by that evening before she went to bed, she had a headache and a sore arm, but that was no big deal. Then on 25Mar2021, she started with flu like symptoms/fever. The headache persisted through that as well. At that point, she did not have tightness or the dry, hacky cough. By the middle of the day on 27Mar2021, her flu-like symptoms were gone. She would consider these to be "non-serious", it was what she expected, as it was seen from the paperwork of the vaccine. By 28Mar2021, all of her symptoms were gone prior to the flare-up. She had typical flu-like symptoms: fever, headache, achy, fatigue on the 2nd, 3rd, and into the 4th day but then they cleared up. By the evening of the 4th day, she started feeling fairly normal. She stated that they were mild flu symptoms. Her temperature was only 100 for about a day. She stated that that was expected. Then, she went into this flare-up about the 10th day after the vaccine. The first 3 or 4 days after the flare up began, the flare up was worsening. Then, she got it under a little bit of control, so she was not coughing all night and having to sit up as she was sleeping. Now, she was concerned about the pain and tightness in her chest and the hacky cough. She wanted to make sure it was not going into like a viral pneumonia or another thing. She did not know. She kept increasing her Advair use and was at the top of that. She was doing the duoneb which she did not usually have to do. She had not had to do that since Jan2020 when she had the 5-week flu, or it could have been COVID (they were calling it a hoax back then). She was using her duoneb 4 times a day and now she was using it to 2-3 times, but she was still getting chest tightness, hacky cough. It was kind of like nausea- it was hard to explain, it was kind of like a chest nausea, which she had also had back in Jan2020 when she had the bad flu. She also would get this laryngitis and had trouble talking. With her flare-up, her chest tightness/nausea feeling in the chest continued. Now, she was getting into laryngitis type of thing, but she could loosen that up with her duoneb but if she got to the point where she could not do that, she would definitely have to see someone right away. She clarified that when her chest got tight, the dry, hacky cough continued/increased. When she did the breathing treatment, it loosened it up for about 3-4 hours and some of the pain would go away in her chest. If she talked too much, she would begin to cough. She had had this flare up 3 times in her life, it was not very common. She was diagnosed with asthma in her 40s, and this was her 3rd time ever having anything like this. This was the first time she had experienced a flare up like this. She had had 3 episodes since she had had asthma in her 40's and all 3 bad episodes were about the same. All the episodes were related to illness, it did not just happen out of the blue. It happened with a viral respiratory thing or the flu. The adverse events did not require a visit to the emergency room or physician office. The patient stated that she would call her physician or the clinic "today or tomorrow". She had not been to a doctor since her asthma flared up. Her respiratory doctor/pulmonologist moved away, there was no respiratory doctor nearby right now. So, her general practitioner was following her because it was a mild case and she had mild asthma. If it was severe, her doctor would make her go to a specialist. Relevant tests were reported as no. The patient used to be followed with pulmonary function tests until her respiratory doctor moved away. The patient stated that she took care of her 94 year old mother several days a week and because of all of the variances coming out, she thought it was her civic duty to prevent it from spreading through the population and creating more variances which was why she received the vaccine. She stated her doses were scheduled a month apart because they expecting to get a shipment of Moderna and they did not. They had to run to Buffalo to get the Pfizer vaccine, but they left her doses scheduled a month apart because the appointments were so hard to get. Normally, it would be 3 weeks. Her card clearly said Pfizer and they told her Pfizer, and they told her the reason for it being scheduled at 4 weeks. The patient called to inquire whether asthma flare-ups had been seen in clinical trials. It was not a reported side effect from the paperwork she received. When she looked online, she could not really find anything. She was thinking of going to a clinic but was wondering if there were any reports of flare-ups with asthma with the vaccine. With regards to causality, the patient stated it was a concern because she usually did not get a flare-up unless she was sick. She stated that there were many variables, and that it was spring, and bugs were out, but she did not usually get a flare-up like this. She stated that maybe it was a challenge to her immune system, the antibodies, but she did not know. She suspected the flare-up was related to the vaccine, but she did not have any idea. She would say yes, but she had no way of knowing. The flare-up usually only appeared if she got ill or something weird happened to her. The clinical outcomes of the events flu-like symptoms, fever, achy and fatigue were recovered/resolved on 27Mar2021; sore arm and headache were recovered/resolved on 28Mar2021; asthma flare up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were not recovered/not resolved; she gets this laryngitis, has trouble talking and she wants to make sure its not going into like a viral pneumonia were unknown. The reporter believed there was a reasonable possibility that the events sore arm, flu-like symptoms, asthma flare-up, dry, hacky cough, pain and tightness in her chest and nausea feeling in her chest were related to BNT162B2. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information the events asthma flare-ups and viral pneumonia are attributed to intercurrent medical conditions, unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
68 2021-04-27 ischaemic stroke had 3 ischemic strokes; This is a spontaneous report from a contactable consumer (patient). A 68-yea... Read more
had 3 ischemic strokes; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 27Feb2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included antiphospholipid syndrome from an unknown date and unknown if ongoing. Concomitant medication included rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. On 19Mar2021, the patient was admitted to the hospital with stroke symptoms, it was determined that she had 3 ischemic strokes on 18Mar2021. The patient was hospitalized for the event from 19Mar2021 to an unknown date for 2 days. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 20Mar2021. Therapeutic measures were taken as a result of the event. The outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been requested.
68 2021-05-07 excessive bleeding, chest pain she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting ... Read more
she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting hurting; she is scared; She used to weight 143 pounds 9 months ago, she states she is swelling up.; overall body aches; cramping; eyes had swollen; fever of 101.9°F/temperature like 101.9 degrees, a fever; chills; nausea; wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in Arm Right on 12Apr2021 11:00 (Lot Number: EP7534; Expiration Date: 31Jul2021) as SINGLE DOSE (at the age of 68 years old) for covid-19 immunisation. Medical history included she is on the borderline of Chronic obstructive pulmonary disease (COPD). She was taking breathing medicine, but has been taken off of it, she is doing so well; osteoporosis; osteoarthritis; osteopenia. Concomitant medication included hydrocodone (HYDROCODONE) taken for osteoporosis, osteoarthritis, osteopenia, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On unspecified date the patient experienced feeling chest pain/her chest is sore, headache/her head just starting hurting, she is scared, she used to weight 143 pounds 9 months ago, she states she is swelling up and overall body aches. On 14 Apr2021, she experienced wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker. She wiped this morning, and she thinks it stopped. She felt cramping. It started light pink, then a couple days ago it was darker. She was a walk in patient at the clinic to be checked out. She lives alone, has no companion for a sex life, she had no new medications. She went to her physician yesterday 22Apr2021, and had a pap smear and blood draws. Her MD told her to take Airborne around the time of the second vaccine. On 16Apr2021 she experienced nausea. On 22Apr2021 the patient experienced eyes had swollen, fever of 101.9°F/temperature like 101.9 degrees, a fever, chills. On 23Apr2021 the patient experienced cramping.The headache has been on and off all weekend. She felt she was dying. The worst yesterday. She read all the Covid symptoms and all her symptoms point toward Covid. She feels like she has Covid from unknown date.She has chest pain and tries to ignore it, but she can't. She has to go get her pain pills because her head just starting hurting.The patient underwent lab tests and procedures which included body temperature: 101.9 degrees fahrenheit on 22Apr2021, blood test: unknown results on 22Apr2021, pap smear: unknown results on 22Apr2021, weight: 143 lbs on 9 months ago. Therapeutic measures were taken as a result of overall body aches. She took gas pain pills, allergy relief pain pills because her whole body hurt. She has been applying warm towels to her eyes to help with swelling. Outcome of fever of 101.9°F/temperature like 101.9 degrees, a fever, chills was recovered on 23Apr2021. Outcome of eyes had swollen, headache/her head just starting hurting, nausea, wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker was recovering. Outcome of feeling chest pain/her chest is sore was not recovered. Outcome of she feels like she has Covid, she is scared, cramping, he used to weight 143 pounds 9 months ago, she states she is swelling up, overall body aches were unknown.
68 2021-05-12 blood clot passing blood clots from her rectum; blood clots; deathly ill; the lymph nodes underneath the arm sw... Read more
passing blood clots from her rectum; blood clots; deathly ill; the lymph nodes underneath the arm swell up / She swelled up on her right side; kind of in the breast/chest area, up a little higher than the breast and it was very uncomfortable; This is a spontaneous report received a contactable consumer, the patient. A 68-year-old elderly female received the first dose of intramuscular BNT162b2 (solution for injection; Lot ER8737 and expiry information not provided) as a single dose in the left arm on 08Apr2021 at 11:00 (at 68-years-old) for COVID-19 immunisation. Relevant medical history included ongoing back problems for which she takes medication. Concomitant medications included unspecified medication for back problems. The patient denied any other vaccines within four weeks prior to this vaccine. The patient reported that she generally gets the flu shot every year and has never had any adverse reactions. The patient also mentioned that she previously tramadol (for an unspecified indication) in the past but has not taken it for years. The patient reported that she received her first dose on 08Apr2021 at (Privacy). The patient explained that within six hours she was deathly ill. The patient reported that stayed very ill for quite a few days. The patient stated when she gets up in the morning, she gets up early and she always goes to the bathroom. The patient stated that on 13Apr2021, when she went to the bathroom, she started passing blood clots from her rectum which went on until 16Apr2021. When describing the blood clots, the patient stated 'envision sunny side up eggs, between six to eight of them, and in between that was all this webbing holding the clots together'. The patient stated while she was urinating, the clots were just pouring out of her rectum. The patient clarified that there was not blood in her stool. The patient explained that she took the opportunity to get some plastic gloves and look through her stool for blood and there was not any. The patient stated that her underwear and the toilet paper was stained. The patient also stated that she was reading that whichever arm you get the vaccine, the lymph nodes underneath the arm swell up. The patient explained that her lymph nodes did not swell up underneath her left arm where she got the shot. She swelled up on her right side. She clarifies she was swollen underneath her arm, kind of in the breast area and chest area, up a little higher than the breast. It was very uncomfortable. The patient denied any visits to the emergency room or doctor's office for the events. The outcome of the event passing blood clots from her rectum was recovered on 16Apr2021. The outcome of the events deathly ill, the lymph nodes underneath the arm swell up / She swelled up on her right side, and was very uncomfortable was unknown.
69 2021-01-01 chest discomfort Metallic taste in mouth as it was being administered. I told them I could taste it. Eyes started h... Read more
Metallic taste in mouth as it was being administered. I told them I could taste it. Eyes started hurting with burning sensation, pressure in both ears and slight numbness across face from ear to ear and under nose. Uncomfortable tightness in chest and a lot of pressure on face feeling like it was hot. I felt a little better after 15 minutes while waiting but never told anyone about symptoms. I walked out and drove home but monitored my symptoms. The symptoms gradually became less and were gone after 1 hour and 45 minutes. I took a dose of benadryl at that time. I slept well that night and woke up with no symptoms and none since.
69 2021-01-11 heart rate increased After the vaccine was administered, she decided to check her pulse and see that was a little high, g... Read more
After the vaccine was administered, she decided to check her pulse and see that was a little high, get scared. She was evaluated by the Fire Rescue at 10:30 am and was released home at 10:45 am.
69 2021-01-11 vaginal haemorrhage Following morning, after receiving 1st Pfizer shot, started bleeding vaginally.
69 2021-01-12 chest discomfort Employee received Pfizer COVID19 vaccine dose 1. After 5 mins, complained of N/V , vertigo, chest ti... Read more
Employee received Pfizer COVID19 vaccine dose 1. After 5 mins, complained of N/V , vertigo, chest tightness.
69 2021-01-12 chest discomfort Nausea/vomiting, chest tightness
69 2021-01-14 fainting Nauseated and lightheaded, near syncope. Lasted about 20 minutes, took vitals, rested, and recovere... Read more
Nauseated and lightheaded, near syncope. Lasted about 20 minutes, took vitals, rested, and recovered.
69 2021-01-15 palpitations Patient had vaccination at approximately 12: 30 pm and remained for an initial observation of 20 min... Read more
Patient had vaccination at approximately 12: 30 pm and remained for an initial observation of 20 minutes. The patient returned to the observation area after 1:30 pm complaining of symptom onset at approximately 1:35 pm of "wooziness", faster heart beat, and legs tingling. She did not want medical help but stayed for an hour of observation in which her blood pressure was taken at least twice in the normal range, sat with her legs elevated for a few minutes but not most of that time. At 2:30pm she reported not feeling any better but now reported tingling in hand and leg of her right side only. BP/hr at 2:35pm were 121/96 and 112 from a seated position and both legs on floor. The patient said she would touch base with her physician who is unnamed. She was also given information and encouraged to fill a report herself with VAERS.
69 2021-01-17 loss of consciousness I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sic... Read more
I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included R.A.D., osteopenia, migraine with aura, the patient had previously suffered episodes of vasal vagal syncopy when she got the flu or other severe illnesses, and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included atenolol, atorvastatin, azelastine, and fluticasone. The patient previously took gramicidin, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced allergies. The morning after receiving the vaccine, she felt quite sick, like she had the flu. When she got up from bed and went to the bathroom to urinate, she became very lightheaded and dizzy. She attempted to return to bed, but passed out on the bedroom floor before she could get to the bed, and seized while she was unconscious. Once she came to, she was helped to bed and, after about 90 minutes, felt much better, and got up, and ate food and had coffee. All events occurred at 07:30 AM on 09Jan2021. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021. Information on the lot/batch number has been requested.
69 2021-01-23 chest pain, troponin increased I became weak and thought I was going to faint. I called the medical professional over and they brou... Read more
I became weak and thought I was going to faint. I called the medical professional over and they brought me into a staged area for triage. My blood pressure was 171/ 104 or 114. I had chest pain. The EMT did and EKG, listened to my heart, and started an IV. The ambulance was called and I was transported by ambulance to the hospital. At the hospital another EKG was taken, blood pressure and blood work. Repeated blood work was taken. I was admitted to the hospital due to elevation of tyoponin level and chest pain. The following day 1/22/21 I saw my PCP and he thought it was related to the vaccine and recommended a cardiologist for the increased levels of tyoponin and chest pain. The cardiologist performed another EKG< more blood work and performed a cardiac catheterization and a ECO. Both were normal. Prior to that I was given a nitro pill as my chest pain was between a 7 and a 8; a few minutes later the nurse asked about my pain level and it was a 3-4. I was given another nitro pill and shortly after I felt extremely faint and my blood pressure was 56/32. I was immediately given a bolus of saline IV . The chest pain continued through the day. The following day, I had no further chest pain, my tyoponin levels returned to normal and I was released from the hospital.
69 2021-01-24 hypertension Patient complained of lips and throat swelling, she also started coughing (dry cough), blood pressur... Read more
Patient complained of lips and throat swelling, she also started coughing (dry cough), blood pressure high at 189/112. She was given 100mg of Benadryl and an Epi Pen was used. She recovered well with reactions subsiding and blood pressure down to 159/96.
69 2021-01-24 heart rate abnormal, blood pressure increased Rapid heart beat in chest, neck and head, Elevated blood pressure Pounding head ache Chills with unc... Read more
Rapid heart beat in chest, neck and head, Elevated blood pressure Pounding head ache Chills with uncontrollable shaking
69 2021-01-25 blood pressure increased sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme f... Read more
sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme fatigue, swollen lymph nodes, increased blood pressure, night sweats
69 2021-01-26 blood pressure increased Patient sat for 20 minutes after immunization, then started experiencing swelling in lips and throat... Read more
Patient sat for 20 minutes after immunization, then started experiencing swelling in lips and throat. She took 100mg diphenhydramine. Pharmacist/Nurse started monitoring blood pressure. Symptoms continued to worsen (with systolic blood pressure reaching 180) so an EpiPen (0.3mg) was administered. Within 1 minute, symptoms started to improve including blood pressure dropping (reaching 130 systolic). The patient sat under observation for an hour and symptoms continued to improve. Within 24 hours symptoms completely resolved.
69 2021-01-27 chest pain 0448 CHEST PAIN AND SHORTNESS OF BREATH; 0450 02SAT 100% WITH NO WORSENING IN CONDITION OBSERVED AN ... Read more
0448 CHEST PAIN AND SHORTNESS OF BREATH; 0450 02SAT 100% WITH NO WORSENING IN CONDITION OBSERVED AN ADDITIONAL 15 MIN. 0512 PT BETTER WANTS TO BE RELEASED. INSTRUCTED IF CHEST PAIN RETURNS TO GO TO er. 170/79; 63 HR; 100% 02SAT
69 2021-01-28 chest pain When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started i... Read more
When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started irritating a little bit. So then i left it alone because I didn't now if that was part of a reaction. When i got home i still had the odor in my mouth. i drank cold water and it went away. I waited. I felt sore on my arm but it wasn't that bad but as the hours went on it started getting more sore and painful. My arm was sore up to my shoulder and the back. After that the pain started traveling towards to my chest and i started getting pain in my chest. i took Tylenol (1 500 mg extra strength at 11:15 PM). So i waited 15 minutes to go to sleep. i got up the next day and everything was the same, i started putting ice on it and gave it time. I took another Tylenol but the pain was in my chest again a little bit. The third day the pain didn't come back in my chest and from then i was alright. I also started getting an itch.
69 2021-01-28 heart rate irregular temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off;... Read more
temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off; first it was up around 163/71 and then over time it was really low 118/58; HR was high; body was jerking; arm that she got the injection in was dropping; dehydrated; urine is darker; real thirsty; extremely weak; tired and exhausted; feeling horrible; couldn't stay awake, fell asleep; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included left hip replaced on 16Nov2020 and had her right hip replaced on 29Dec2020. There were no concomitant medications. Patient reported that she got the shot at 1:30 pm and on the way home she started getting tired and exhausted on 14Jan2021. She got home and went right to bed. She felt like she couldn't stay awake, fell asleep and woke up about 6 pm then with a temperature of 105.5 and stated it would fluctuate between 104-105. She was just feeling horrible. At 7:30 pm, patient had a temperature of 103.5 and at 7:45 pm, her temperature was 104. On 14Jan2021, patient stated that she couldn't see straight, had blurred vision, having trouble walking, her balance was off and falling into walls. Her body was jerking and the arm that she got the injection in was dropping. Patient called her cardiology office, and was advised to take Tylenol 3-4 times per day and alternate it with Motrin. She was also taking coated 325 mg aspirin. She can hold her head up and was not jerking as much as she was. She was doing noticeably better. Patient had put ice bags on her groin, stomach and throat to try to cool down through the night. This brought temperature down to 103. She woke up at 12 am she was 102. Her temperature at the time of report was around 101-102. She took her blood pressure it was going crazy, first it was up around 163/71 and then over time it was really low 118/58 and heart rate was 130 for a while and went to 103. The back of her neck still felt so weak and she still feels extremely weak and exhausted. She went on to report that her HR was high and B/P was up but since then it has come down. The night of 14Jan2021, her b/p was low.On 14Jan2021, patient was also real thirsty and her urine was darker and was probably dehydrated and thought that she was real jerky muscle-wise, like she is not in control of anything last night. That she has not taken BP or heart rate on 15Jan2021, but it was not pounding today though. She was doing better today at the time of report. Patient was recovering from the events of fever, blurred vision, and balance was off; not recovered from tired, jerking, and dehydration. Outcome of remaining events was unknown.
69 2021-01-29 fast heart rate SVT Tachycardia lasted 10 minutes. 43 hr post injection.
69 2021-01-30 hypotension Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin,... Read more
Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin, Zofran, chicken broth for electolytes> Signs included hypotension, nausea, headache, weakness, I am a retired doctor married to an Endocrinologist and living to take care of my 2yo grandson for my daughter who is a resident in PEDS , I and my family are very familiar with managing my illness, which infrequently presents with crisis and I very rarely must be hospitalized .
69 2021-01-30 chest pain Chest pains: relieved after 45 minutes following dos of 2 aspirin and another dose of 2 aspirin afte... Read more
Chest pains: relieved after 45 minutes following dos of 2 aspirin and another dose of 2 aspirin after 30 minutes.
69 2021-01-31 blood pressure increased, heart rate increased Pt developed rapid heartbeat and high blood pressure the day following the injection. These were not... Read more
Pt developed rapid heartbeat and high blood pressure the day following the injection. These were not getting better, so after several hours pt had to go to Urgent Care to be evaluated further. It was advised pt go to ER for f/u.
69 2021-02-02 blood pressure increased Blood pressure jumped very high 191/95 evening a few hours after injection Called fam Dr. Advised ... Read more
Blood pressure jumped very high 191/95 evening a few hours after injection Called fam Dr. Advised to do another 100 mg metoprolol Pressure still high in morning. Cardiologist added morning dose 50 mg metoprolol Not working Given clonodine to take for emergency because still seeing nighttime systolic over 180 snd diastolic at 103. On day 13 post injection bp still 189/105. Amlodipine added. Three doses of clonidine used so far.
69 2021-02-03 palpitations Client felt nauseous and had palpitation. Paramedics assess client on site. Client was released at... Read more
Client felt nauseous and had palpitation. Paramedics assess client on site. Client was released at 10.
69 2021-02-03 heart rate irregular Fast heartbeat, dizziness, sore arm, trouble lifting and pain, still have problem 2 weeks later
69 2021-02-03 chest discomfort Patient received tightness in chest. Thought to be allergic reaction. Pt took Benadryl and within mi... Read more
Patient received tightness in chest. Thought to be allergic reaction. Pt took Benadryl and within min symptoms went away
69 2021-02-03 lightheadedness Within 15-minutes of vaccination, the patient became nauseous, clammy, dizzy, and had a near syncopa... Read more
Within 15-minutes of vaccination, the patient became nauseous, clammy, dizzy, and had a near syncopal episode. EMS reported the patient's blood pressure being 70/40 mmHg. EMS administered IV saline and transported patient to emergency department. In the emergency department, patient stabilized and was discharged shortly after.
69 2021-02-03 palpitations Within 15-minutes of vaccination, the patient reported nausea and felt that their heart was racing. ... Read more
Within 15-minutes of vaccination, the patient reported nausea and felt that their heart was racing. EMS managed patient's condition on-site.
69 2021-02-05 heart rate increased I received my second shot on Friday 01/29/21 at 5:30 pm. The next morning (01/30/21) at @ 10:45 am ... Read more
I received my second shot on Friday 01/29/21 at 5:30 pm. The next morning (01/30/21) at @ 10:45 am I experienced an extremely rapid heart rate (195+) which did not go down even after laying down and putting my feet up. My husband took me to the hospital ER and they gave me cardizem (10 mg via I?ve) which brought it down. I was let there for four hours then transferred to the main hospital and kept overnight in the cardiac decision unit and monitored. I really released @ 12:25 pm on 01/30/21 and referred to my own cardiologist
69 2021-02-08 blood pressure increased Approx 10-15 minutes after receiving the vaccine, client started c/o feeling shaky and overall jitte... Read more
Approx 10-15 minutes after receiving the vaccine, client started c/o feeling shaky and overall jitteriness, and elevated blood pressure. She was monitored for several minutes and started feeling better. She admits to being nervous to take the vaccine and has had several episodes like this before after vaccines. She was steady enough to drive herself home and she went to bed for a few hours and woke up feeling fine except for a sore arm for 2-3 days. Had physical 3 days after this episode and he said she was fine.
69 2021-02-09 palpitations, heart rate increased Pfizer-BioNTech COVID-19 Vaccine EUA Fast Heartbeat - initially after injection but I thought it was... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Fast Heartbeat - initially after injection but I thought it was a panic attack. But it subsided and I drove home. About 1.5 hours after the injection I realized my heart was pounding. I felt the pounding/racing heartbeat for about another hour. My BP was normal, pulse was 90 but it has often been 90 on other occasions.
69 2021-02-10 chest pain Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength ... Read more
Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength headaches, ripping pain in chest, ribs, upper back, shoulders, neck, head. I could not sit or lie down comfortably. I saw Dr. on February 1 who ordered a CT scan which was clear. He prescribed Prednisone and Robaxin 500 mg. I saw Dr. again on February 4 at which time most of the pain subsided but my body was very sore. It is now February 11 and I still feel a bit of cloudiness, but am much better. Hopefully, I'll feel like myself within a few days.
69 2021-02-10 increased heart rate, hypertension, heart rate increased deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache... Read more
deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache; body aches; fatigue; dizziness; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; will fall asleep through the day for 3-4 hours at a time and she does not even nap usually; Muscle pain; Neck ache; Backache; Problems with walking; problems with balance; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3246), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a single dose for covid-19 immunization. Vaccine was not administered in a military facility. Medical history included ongoing ulcerative colitis, ongoing high cholesterol, ongoing high blood pressure, celiac disease from 2005 (this has been tested too many times to count and it has been negative since after initial diagnosis 2005), arthritis (all her life) ongoing, hip replacement surgeries first done in 2005; repair of same hip in 2015; other hip in 2017. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines include Pneumonia Vaccine, Shingles Vaccine and Flu vaccines; all on an unspecified date for immunization. She never had adverse events with those. Ongoing concomitant medications included rosuvastatin (5 mg tablet) for high cholesterol, mesalamine (400 mg capsule) for ulcerative colitis and lisinopril from 2018 for high blood pressure. According to the patient, she knows that mesalamine is an immunosuppressant and anti-inflammatory to keep inflammation in the colon down. This consumer was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021 14:30 with immunosuppressant mesalamine. The night of 14Jan2021 patient had headache, chills, body aches, diarrhea, fatigue, fever and dizziness like Covid 19 symptoms. She went to the ER during the past 11 days for IV fluids due to deyhydration from the diarrhea. Today, 25Jan2021 is the first day she has been out of the house, except to go to the ER, since she received her 1st vaccine dose. On Jan2021 muscle pain, neck ache, backache, problems with balance and problems with walking. Events probably started with intense diarrhea starting 14Jan2021; then Fever over 102 degrees Fahrenheit and chills 14Jan2021; Specific onset dates and onset times unknown otherwise other than between 14Jan2021 and 16Jan2021 onset dates. It was a rolling week of agony after that with one adverse event after another until she ended up in the emergency room on 16Jan2021 because she was so dehydrated and was really sick. She was not admitted to the hospital related to any of these events; but while in the emergency room she was given intravenous fluids; a chest x-ray; blood work; after maybe 5-6 hours she was sent home; she was also given a COVID test which was negative; and then 2 days later took another COVID test which was also negative. Both COVID tests were Rapid Tests: on 16Jan2021 and 18Jan2021. On the Chest xray they suggested she had some sinus tachycardia which is just a rapid heartbeat and not surprising; nothing else showed up on Chest x-ray; as far as anything else testing/results wise there was only some facetious blood work which they just said to follow-up with her PCP regarding but nothing really out of the ordinary. She can finally out of bed on a regular basis for a couple of hours daily; she is still very fatigued; she has no muscle pain, neck aches or body aches at this time; she does not have the strength she should have; is no longer experiencing headaches or fever; but is extremely tired. She will fall asleep through the day for 3-4 hours at a time and she does not even nap usually (Jan2021). She has not driven yet but assumes probably once she is a little stronger she will be able to drive again. She did not have upper respiratory, chest or cough issues. The outcome of the events fever, headache, body ache, muscle pain, neck ache was recovered on Jan2021; fatigue was not recovered. The outcome for the other events was unknown.
69 2021-02-11 chest pain Patient experienced dizziness and a burning sensation in chest and throat within minutes of this inj... Read more
Patient experienced dizziness and a burning sensation in chest and throat within minutes of this injection, that initially resolved only to reoccur later that afternoon in conjunction with chills, body aches, headache. Patient was feeling so bad with confusion and dizziness the next morning such that she was unable to get out of bed and had call in sick to work. Patient symptoms continued for the next week and she was unable to return until 19 January (but still symptomatic and short of breath on exertion). Patient was tested for COVID-19 infection on 19 January which was negative. Patient then followed up with her primary care doctor the following and retested for COVID-19 (also negative again). Primary care provider performed basic labs without revealing any abnormalities. Patient does not feel back to normal at this time - she continues to have intermittent chills and the headaches only stopped in the past 7 days.
69 2021-02-11 lightheadedness, chest discomfort, pallor Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over he... Read more
Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over her chest, light headed, patient said she feels like she was going to pass out immediately after vaccine administration. VS 100/60 mmHg, pulse 64, RR 22. Patient complaints of headache, nausea and skin clamy and warm. Site manager made aware, o2 @ 2 L via nasal cannula administered. EMS transport to hospital. Daughter was made aware via VM, unable to reach 3x attempts.
69 2021-02-11 hypertension, heart rate increased, palpitations Symptoms include rapid heart rate, elevated blood pressure, nausea, and palpitations lasting for app... Read more
Symptoms include rapid heart rate, elevated blood pressure, nausea, and palpitations lasting for approximately 4 hours. Patient has a history of heart disease so the vaccine may have triggered an existing condition.
69 2021-02-14 blood pressure increased Patient reported mouth/tongue tingling. Reported she had a h/o malignant HTN. VS at 1037: 182/94, ... Read more
Patient reported mouth/tongue tingling. Reported she had a h/o malignant HTN. VS at 1037: 182/94, 93 HR, 98%. EMS called at 1035. Physician on site evaluated patient while waiting for EMS. VS at 1045: 158/100, 81 HR, 98%. EMS arrived at 1047. FSBS 140. VS by EMS 180-90, 87 HR, 98%. EMS left with pt at 1057 to go to local ED for further evaluation.
69 2021-02-14 heart rate increased The evening of Feb 4th she started feeling tired. Feb 7th still tired, started feeling anxious, hear... Read more
The evening of Feb 4th she started feeling tired. Feb 7th still tired, started feeling anxious, heart was beating harder and faster, stomach felt upset, she was burping a lot Feb 8th went to primary care doctor. BP was 175/90. She felt dizzy and lightheaded, ringing in ears was louder than usual She gave another BP med to take, but she didn't take it. Instead took an extra of hr own propranolol. Yesterday was the first day the sxs were better. Other than taking the extra propranolol on Feb 8th, she just rested 2/11/21 is the first day the tiredness has let up
69 2021-02-15 fast heart rate Developed fever, fatigue, extreme joint pain, HA, ear ache, tachycardia, SOB. Had Covid 11/4, and t... Read more
Developed fever, fatigue, extreme joint pain, HA, ear ache, tachycardia, SOB. Had Covid 11/4, and these are all symptoms that she had when she had Covid. Continues with HA, ear ache, joint pain, fatigue and SOB today. MD has not responded yet.
69 2021-02-15 fainting Syncope, dizziness. BP 145/64, pulse 73, O2 sat 100%. 2 L Oxygen via nasal cannula given.
69 2021-02-16 chest discomfort Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funn... Read more
Took 1st shot and got anxious; a lot of fatigue; felt something in her chest area/chest feeling funny; Head spinning; Weakness; nerve pain; stomach nausea; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration, in the right arm, on 16Jan2021 14:15 at a single dose for covid-19 immunization. Medical history included left-sided breast cancer from 2005 and lymph nodes removed on her left side. Concomitant medications included pravastatin and a lot of vitamins. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccine administered on same date of the Pfizer suspect. It was reported that the patient took first shot and got anxious on 16Jan2021. The patient also experienced a lot of fatigue on 16Jan2021, went home and got worse then was hospitalized. The patient had a virtual visit with her doctor and wanted some advice, and her doctor didn't give her any prescriptions. The patient also felt something in her chest area on 16Jan2021, after receiving the COVID-19 vaccine. Events anxious and fatigue required emergency room visit. The patient was hospitalized from 25Jan2021 to 27Jan2021 for the events anxious and fatigue. The patient also experienced head spinning, chest feeling funny, weakness and stomach nausea on unspecified date in Jan2021. Reported she was given all kinds of medicine in the hospital. She said as long as she was laying down, she was good. She said once she got up, and moved around, she felt the weakness again. She said she was put on depression medicine (Jan2021) while in the hospital, and was given 4 different prescriptions at discharge. She said the only thing that helps her go to sleep at night is a 1/2 tablet of generic alprazolam for anxiety. She said she knows she can't stay on the generic alprazolam forever, clarifying that is why the doctor put her on the depression medicine. Reported she was given the following medications in the hospital, as well as, prescriptions to continue the medications at home after her hospital discharge: escitalopram 10mg for depression. She said she is to take one escitalopram 10mg every evening for 30 days. She said she was given escitalopram 10mg for the two days she was in the hospital. Generic gabapentin 100mg for nerve pain (Jan2021) and she is to take 1 capsule nightly for 30 days. She said she started the gabapentin 100mg while she was in the hospital. Pantoprazole 40mg, she was given a one-time small IV bag of pantoprazole 40mg for her stomach while she was in the hospital (clarified she was given on 27Jan2021 at 05:26). She said she was having some stomach nausea (Jan2021), and the pantoprazole 40mg was to protect her stomach. She said she told the doctor she didn't want to take the pantoprazole 40mg any longer because she thought she was being given too many different medicines. Reported her fatigue is not the same as it was when she went to the hospital, but the fatigue is still there. Reported her lab work (Jan2021) was good, and her test results were fine when she was in the hospital. She said she was told she was 30% from being on the verge of having heart disease. She said her doctor told her the heart disease was preventable if she eats right, and makes some other changes. She said her cholesterol has gone done. She said she just has the fatigue, and that was why she was put on medicine. Therapeutic measures were taken as a result of the event anxious, fatigue, nerve pain and stomach nausea. Outcome of the event fatigue was recovering while it was unknown for all the other events.
69 2021-02-21 blood pressure increased After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this ... Read more
After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this past two weeks. I experienced nausea, dizziness, felt like my brain was on fire. Last week I could not comprehend what people were saying, I did not understand. Extreme irritation, anxiety, depression. Fatigue and tiredness, my legs are weak. My blood pressure went skyrocketed: 169/80.
69 2021-02-23 fast heart rate Patient arrived to ED with itchy throat, facial swelling and erythema and tachycardia. Patient was g... Read more
Patient arrived to ED with itchy throat, facial swelling and erythema and tachycardia. Patient was given Benadryl and Pepcid (dose and route unknown), and sent home with a prescription for Methyprednisolone 4 mg dose pack and Ventolin for home use. Patient reports reactions to other medications in the past, having an extensive allergy list.
69 2021-02-23 blood pressure increased She got the vaccine which was fine, at the end of the 20 minute waiting period had a spot the size o... Read more
She got the vaccine which was fine, at the end of the 20 minute waiting period had a spot the size of a dime, really sore and pink. On her way home she started having bowel issues, got home and an hour to hour and half later got explosive diarrhea, which lasted 24 hours. The spot on her arm got larger, more tender and felt warm to touch. It got to be the size of a half softball size, no swelling. Then she started having trouble breathing, could not walk as far or fast without breathing problems. She then took it easy, and the breathing issues got worse for 36 hours. On Sunday her arm was better, less sore and the diarrhea had stopped. She then stopped improving and on Tuesday 2/16/21, she was told to go to the minute clinic on 2/18/21 and when she got there her pulse rate was 40, her oxygen level was 93, and her BP was elevated. The NP there she got her oxygen level up to 94, was real raspy in her lungs. She was sent to the UC and they sent her to the ER. She was seen in the ER and isolated her, did an EKG, had a chest x-ray, gave her breathing treatments, and waited on her results, which all came back fine. They gave her 150 mg of Prednisone, another breathing treatment and within 1 1/2 hours her oxygen level was up to 97 and all of her tests were negative and they sent her home. She has now been home since last Thursday with nebulizer treatments Ipratropium bromide and Albuteral sulfate 3 times a day, rescue inhaler 4 puffs every 6 hours, Advair twice a day as well. She does have a FU with her doctor tomorrow for recheck. She feels that she is almost back to normal.
69 2021-02-23 heart rate increased The itching was located just below the injection site at a spot where the skin was a little red; The... Read more
The itching was located just below the injection site at a spot where the skin was a little red; The itching was located just below the injection site at a spot where the skin was a little red; terrible itching in her left arm; out of balance, her balance was messed up; nervous; Sweaty; Feeling hot; felt like her heart was racing fast; felt dizzy/terrible lightheadedness; Feeling anxious; trouble sleeping; sharp pain in her muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health care professional reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot EL9263) via an unspecified route of administration at arm left on 24Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included drug allergies, IV contrast reaction. The concomitant medication was not reported. It was reported patient got the Pfizer COVID 19 vaccine Sunday 24Jan2021 at 13: 00PM in the left arm. She was scheduled for the second dose of the vaccine 16Feb2021. she got the vaccine and was perfectly fine; she started the wait time of 45 minutes and about 10 minutes into it she got really hot and felt like her heart was racing fast; felt dizzy on 24Jan2021. A nurse practitioner and a doctor came over and sat with her; she got some water and she was okay. They thought it was anxiety related to coming into a crowd, but for the next 36 hours she continued to feel anxious and on edge; she felt like she had too much caffeine. That night she had trouble sleeping; she had sharp pain in her muscles on 24Jan2021, it would be in one of her thighs then the other one. This was about 12 hours after the vaccine. States she took some tylenol and it did help. Adds she just continued to feel anxious and she was sweaty. States she has never has anything like this before. Today she felt perfectly fine; all of her symptoms had resolved. Then today, when she was driving to a routine GYN exam and she experienced a terrible itching on her left arm on 24Jan2021. It was sudden and startled her. The itching was located just below the injection site at a spot where the skin was a little red, feathery red, just below the injection site. Now the itching has stopped but it is still red. she couldn't hardly feel it being injected, she doesn't usually have reactions to vaccines, she never had anything, but she has a few drug allergies, and she was separated out, she was flagged to wait 45 minutes after, instead of the 15. She does have an IV contrast reaction, and some other things, nothing she knew was in the vaccine, she was fine and wasn't worried that she was aware of. She thinks she got too hot, she had on a coat, she was sitting and panning through stuff, reading on her phone, and all of a sudden she had terrible lightheadedness, she never fainted in her life, she is pretty sturdy, she didn't know what to think, she was lightheaded, and it was not vertigo, not like the room was flying, but she was like out of balance, her balance was messed up, and she sat there a minute, she was too hot, she got out of her coat, and it got worse, she could feel her heart racing, and she was talking to herself, she thinks she nervous, she could feel her heart pounding, and was instructed to raise her hand if she had issues, so she raised her hand, a nurse practitioner came over, she raised her hand, and the doctor making rounds came over and he said take off your mask off, she did, that helped somewhat, it was that blasted mask, she couldn't get enough air, he gave her water, she thinks she got too hot and perhaps got nervous and didn't think she was she said she's not been around people, and was suddenly in a huge crowd, everyone was appropriately distanced, it was an extreme presentation, after 5-6 minutes, she was good, it went away, but for 36 hours she didn't feel right, she could feel sometimes her balance wasn't right, she was just not herself, she could do her usual, she lives on a farm, she did usual farm stuff, but was not herself, and in the night, she woke several times, her heart was beating too fast, too much, but she went back to sleep, and she told her son, she said it felt like she had had 4-5 cups of really strong coffee. So the next day she was ok. Absolutely her normal, and then she didn't think anything about it, and was driving to a routine GYN exam, which was canceled last moment due to an emergency, she was driving and suddenly her arm started itching, this was Tuesday, so 48 hours after, not the site, it was distal, underneath it, maybe 2-3 inches under injection site. The site did nothing, she looked that night, no redness, lump, no raised area, no warmth, nothing, but then she had itching, intense itching like poison ivy, and she scratched and thought wait a minute, at her appointment she looked at her arm, this area was 3-4inches under the site, that was red, feathery looking and flat, macular, not raised, no induration, no warmth, no lump, no pain, it was feathery dusty red and the next day it was gone, she did nothing to it, she thought to put hydrocortisone, and looked at it, but it was so faint and wasn't itching. The seriousness was reported as non-serious. The outcome of the events was Feeling hot was recovered on 24Jan2021; Heart rate increased; felt dizzy; Muscle pain; Sweaty was recovered on 25Jan2021; Feeling anxious was recovered on 26Jan2021; Vaccination site rash; Vaccination site erythema recovered in 2021. Vaccination site pruritus was recovering; Difficulty sleeping; Loss of balance, Nervous was unknown.
69 2021-02-24 palpitations My heart began racing about 3 minutes after receiving the shot. It lasted about 10 minutes. I was sl... Read more
My heart began racing about 3 minutes after receiving the shot. It lasted about 10 minutes. I was slightly light headed for a minute or 2.,I felt fine after about 20 minutes.
69 2021-02-24 chest discomfort, hypertension, cardiac failure congestive Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their ... Read more
Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their arms, and chest pressure. EMS evaluated patient on-site. Patient was hypertensive (184/96). 12-lead EKG was NSR, rate of 79 bpm, no ST elevation. FSBG was 137 mg/dL. ETCO2 was 40mmHg with normal square waveform. EMS initiated transport to Hospital Emergency Department. En route, patient became more hypertensive (200/106). In ED, she remained hypertensive and was admitted to inpatient telemetry unit. Patient had 1-night stay to rule out cardiac-related events. Anaphylaxis was ruled out. Discharged with diagnosis of vaccine reaction and chest tightness.
69 2021-02-25 coughing up blood 3 days after vaccine started coughing up blood clots. Started off as a couple small clots then withi... Read more
3 days after vaccine started coughing up blood clots. Started off as a couple small clots then within a half hour later I coughed up the size of a quarter Went to ER and then was admitted.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9269), intramuscular at the right arm on 05Feb2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis (RA), transient ischaemic attack (TIA), atrial fibrillation (AFib), thyroid nodules, and back surgery. The patient's concomitant medications included methotrexate, atorvastatin, rivaroxaban (XARELTO), ergocalciferol (VIT D), and zinc. The patient was not pregnant at the time of vaccination. The patient previously took sulfur and acetylsalicylic acid;oxycodone hydrochloride (PERCODAN). The patient previously received the first dose of BNT162B2 (lot number: EL8982) on 15Jan2021, 01:30 PM at left arm for COVID-19 immunization. On 08Feb2021 23:45, 3 days after vaccine started, patient experienced coughing up blood clots. It started off as a couple small clots then within a half hour later, she coughed up the size of a quarter. She went to the emergency room (ER) and then was admitted for 3 days. The patient underwent lab tests and procedures which included nasal swab: negative on 09Feb2021. The patient had Cat Scans and broncoscopy as treatment for the event. Facility were the most recent COVID-19 vaccine was administered was reported as other. The outcome of the event was recovered on Feb2021.
69 2021-02-25 hypertension 69 yr old female felt dizzy and lightheaded in observation area. Pt was moved to medical room and bp... Read more
69 yr old female felt dizzy and lightheaded in observation area. Pt was moved to medical room and bp was taken and in the 190?s systolic. Pt has a bump on the injection site of her arm with some tenderness. Pt stated her bp has been high and pt is on a new blood pressure Med she didn?t know the same to. Pt rested for over 30 minutes and bp reduced to 180?s systolic. Pt states she gets dizzy when she gets high blood pressure reactions and she is due for her meds now and forgot them at home. Pt states her husband will bring her home to take her meds and she?ll see how she feels . If she feels worse she?ll go to the hospital . Pt also states she will see her primary doctor to have her meds adjusted since she is on the lowest dose. Pt lump on her injection site was decreased and pt signed a release to be let back into the observation area where she checked out.
69 2021-02-25 heart rate increased Immediately following administration of the patient's second dose, the patient reported feeling "pul... Read more
Immediately following administration of the patient's second dose, the patient reported feeling "pulsation up to her neck". Vitals checked with HR in 160?s, BP 116/80, pulse 96. Denied chest pain, nausea, SOB and all other major symptoms. Tried vagal maneuvers, HR remained elevated. Called EMS.
69 2021-02-25 chest discomfort The pressure across my chest and like under my ribs about 6 inch hold away across; I did feel like v... Read more
The pressure across my chest and like under my ribs about 6 inch hold away across; I did feel like vomiting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Batch/lot number: EL9261, via an unspecified route of administration on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Medical history included bypass surgery in Mar, diabetic and seizures from an unknown date and unknown if ongoing. The patient was taking several medications. Patient stated she had the first vaccine (Covid-19 Vaccine by Pfizer) on last Friday and done okay but then she had 10 O'clock in the morning and about 1 O'clock in the morning she woke up with all the pressure across her chest and like under her ribs about 6 inch hold away across and she did feel like vomiting and she was wondering if that was a reaction to that shot and if she should get the second one, she was just kind of concern what she should do it. No treatment was received for the events. The events didn't require Physician Office/ Emergency Room visit. The patient didn't perform any test. The outcome of the events was unknown.
69 2021-02-25 cardiac failure congestive, oxygen saturation decreased disoriented/disorientation; low oxygen saturation; acute CHF; This is a spontaneous report from a co... Read more
disoriented/disorientation; low oxygen saturation; acute CHF; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3247, expiry date: unknown), via an unspecified route of administration on 23Jan2021 15:15 (at the age 69 years old) at a single dose, in the right arm for covid-19 immunisation. Medical history included fibromyalgia and polymyalgia. The patient's concomitant medications included other medications both prescribed and over the counter. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination. On 24Jan2021 at 0900, the patient experienced disorientation that was present then went away and the patient seemed to be okay; low oxygen saturation and acute congestive heart failure (CHF). On Monday, she was disoriented again and went to emergency room (ER). All the events resulted in emergency room visit and hospitalization for seven days. The patient underwent lab test and procedures which included nasal swab covid test on 25Jan2021 which showed negative. Outcome of all the events was recovered on unspecified date.
69 2021-02-27 heart rate increased, blood pressure increased MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the ... Read more
MY heart rate increased to 88 when my normal is 55 and my blood pressure went to 246/120 within the first five minutes. I felt totally incapacitated, nauseous, lightheaded, "wiped out", generally drugged and ill. This lasted for about 45 minutes and then subsided. For the rest of the day I had periods off and on of feeling exhausted and tired.
69 2021-02-27 heart rate increased Within 10 seconds I began to feel that something was wrong. A full body response of a swirling con... Read more
Within 10 seconds I began to feel that something was wrong. A full body response of a swirling congestion, extreme weakness. very blurry vision and couldn't think straight. I had trouble walking to recovery room, felt nauseous and weak and had a very fast heartrate. I had to stay in private recovery room for 45 min. I was still very ill and nervous at this point. I left with a family member and asked to be driven to the nearby hospital emergency room. For a precaution . We parked across from ER entrance for another 1 hour till I slowly regained strength to 50% normalcy. I went home afterwards and had to go to bed. I was unable to drive my own vehicle home. Day 2, still feel weak, shaky and not normal. I consider this a serious adverse reaction that did not receive medical intervention but will prevent me from getting the second Pfizer shot. After 5 hours post injection I felt 60% normal . Day 2, 70 per cent normal. The vaccination facility was not able to do blood pressure monitoring ( which is a problem for anyone experiencing reactions.) They said their protocol was to call 911/ambulance. My blood pressure was checked by a certified PA with professional equipment at the 3 hour post injection time and the diastolic pressure was still below 50. And heart rate above normal. Still weak and nauseous.
69 2021-03-01 palpitations PALPITATIONS. Waited an extra 15 mins- Evaluated by EMS-Cleared
69 2021-03-01 heart flutter fluttering. Evaluated by EMS- Cleared
69 2021-03-01 platelet count decreased she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea ev... Read more
she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea every 15 minutes; required hospitalization on 2/3/2021. Was hospitalized at Hospital. Hospital course was complicated by sepsis, pressors, intubation, GI bleed with ruptured rectum requiring surgery (ostomy). anticipated discharge 3/3/2021.
69 2021-03-02 chest pain "feeling lightheaded", no chest pain, no sob. She has not eaten, symptoms resolved after crackers ... Read more
"feeling lightheaded", no chest pain, no sob. She has not eaten, symptoms resolved after crackers and ginger ale
69 2021-03-02 palpitations Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from ... Read more
Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 69-years-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Lot number: EL9262) via an unspecified route of administration on 17Feb2021 13:00 on Left arm at single dose for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included simvastatin, ropinirol [ropinirole] (ROPINIROL [ROPINIROLE]), vitamin d3 (VITAMIN D3). The patient previously took first dose of bnt162b2 (COVID 19 Pfizer Bio Tech) on 27Jan2021 01:15 PM on Left arm for covid-19 immunisation, montelukast and experienced drug hypersensitivity. The patient experienced stuffy nose, chills, strong heartbeat, severe diarrhea, headache all on 18Feb2021 01:15AM with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. The event was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
69 2021-03-02 lightheadedness felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to... Read more
felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to the floor and tried to take deep breaths, ...never lost consciousness"; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm, on 15Feb2021 at 04:45 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included trazodone (MANUFACTURER UNKNOWN) and letrozole (MANUFACTURER UNKNOWN). The patient previously took codeine (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, tetracycline (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, doxycycline (MANUFACTURER UNKNOWN for an unspecified indication and experienced allergies, and cyclobenzaprine hydrochloride (FLEXERIL) for an unspecified indication and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Feb2021 at 01:15, the patient felt hot, nauseous, and lost control of bowels. The events were reported as non-serious. The clinical course was reported as follows: About 8.5 hours (as reported) after the vaccination, the patient briefly felt hot and nauseous. She knew she would pass out soon, so she lowered her head to the floor and tried to take deep breaths. The patient lost control of her bowels but never lost consciousness. The episode was reported to be over in about 20 minutes. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered on 16Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
69 2021-03-02 chest pain raised bump on arm at injection site; Chest pain; This is a spontaneous report from a contactable co... Read more
raised bump on arm at injection site; Chest pain; This is a spontaneous report from a contactable consumer reported for herself (also reported as nurse). A 69-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiration date unknown) via an unspecified route of administration on the left arm on 25Jan2021 at 12:15 PM at a single dose for COVID-19 immunisation in the hospital. Medical history included asthma and hypertension (controlled), sulfa allergy all from an unknown date. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), simvastatin and spironolactone. The patient previously took propylene glycol and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced well defined raised bump on arm at injection site and chest pain both on 25Jan2021. It was reported that chest pain on the evening of 30Jan2021 resolved after 45 minutes after taking 2 aspirin, followed by 2 more after 30 minutes. The events were assessed as non-serious by the reporter. The patient was recovering from well defined raised bump on arm at injection site and chest pain. The patient has not been tested for COVID-19 since the vaccination.
69 2021-03-02 blood pressure increased, lightheadedness she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing... Read more
she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing in the ears; Hot flashes; Blood pressure went up; Was so dizzy if she moved her eyes she would nearly pass out; Was so dizzy if she moved her eyes she would nearly pass out; Very weak and tired; Very weak and tired; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3247; expiration date: unknown) at vaccination age of 69-year-old via an unspecified route of administration left arm on 28Jan2021 10:00 at a single dose for To keep from getting COVID (covid-19 immunization). The patient medical history was none. The patient's concomitant medications were not reported. The patient stated that she got the first vaccine the other day and within 12 hours (28Jan2021 22:00), she was not feeling well. At 8:30 the next morning (29Jan2021), she was sick for about 8 hours. She was throwing up, had a headache, chills, ringing in the ears, hot flashes, her blood pressure went up, she was unable to get anything down, not even medication [pending clarification]. She was so dizzy if she moved her eyes, she would nearly pass out. She could not move out of the chair for about 6-8 hours. The dizziness was severe and awful. She added only one ear is ringing really bad, the right ear. It is off and on and persisting. Her very weak and tired which was persistent. One hour it may be bad and the next she will be drained. The patient inquired if it is true since she heard the second dose is worse. She also wants to know if she should get the second dose or not. The received treatment for the adverse events was reported as none [pending clarification]. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement) was reported that her blood pressure went up and recovered on 29Jan2021, and weight was 175-180 pounds on an unspecified date. The outcome of the event feeling unwell was unknown, as for the events weakness, tiredness and ringing in ears were not recovered, while the outcome of the other events was recovered on 29Jan2021. Information about Lot/Batch number has been requested.
69 2021-03-03 fast heart rate A day after the vaccine, she experienced shortness of breath. This worsened and as a result, trigge... Read more
A day after the vaccine, she experienced shortness of breath. This worsened and as a result, triggered a COPD episode which also led to Tachycardia. Her heart rate was 170 and she could not breath. She had to be rushed to the hospital in an ambulance.
69 2021-03-03 chest discomfort Shortly following injection, the patient complained of chest tightness, itchy throat, and mild eryth... Read more
Shortly following injection, the patient complained of chest tightness, itchy throat, and mild erythema of the skin with pruritus. Serial vital signs were monitored for almost 2 hours and were stable. She was in no acute distress. 8 mg of dexamethasone was administered with improvement of her symptoms.
69 2021-03-03 inflammation of the pericardium, chest pain chest pain, subjective fever 9 days after vaccine; 10 days after hospital admit Dx with pericarditis... Read more
chest pain, subjective fever 9 days after vaccine; 10 days after hospital admit Dx with pericarditis + 8mm pericardial effusion
69 2021-03-04 chest discomfort Complaining of nausea, chest tightness, dry heaving. BP 182/106 (pulse 125), 97% O2 sat. Final BP 15... Read more
Complaining of nausea, chest tightness, dry heaving. BP 182/106 (pulse 125), 97% O2 sat. Final BP 154/97 (pulse 94), 98% O2 sat.
69 2021-03-04 oxygen saturation decreased Increasingly short of breath, lethargic. O2 sat dropped to 75%. Placed on 10 liter oxygen. BP 150/70... Read more
Increasingly short of breath, lethargic. O2 sat dropped to 75%. Placed on 10 liter oxygen. BP 150/70 (pulse 74). BP 126/97. BS 292. Sent to the ED.
69 2021-03-04 heart rate increased Pt reported rapid heart rate to EMT at 1410. EMT assessed pt. HR: 82 and no SOB. Pt reported hx of h... Read more
Pt reported rapid heart rate to EMT at 1410. EMT assessed pt. HR: 82 and no SOB. Pt reported hx of hypertension, allergies to PCN, and severe allergic reaction to flue vaccine 2 years ago. Pt offered adult dose of diphenhydramine. Pt refused diphenhydramine. Pt offered EMS. Pt denied EMS. Pt advised to wait 15 extra minutes. At 1417 pt reported dry throat and feeling hot. Flushing was observed by RN. Pt was moved outside. Pt was offered EMS for a second time. Pt agreed to EMS. EMS was activated at 1420. EMS arrived at 1430 and assumed care. Pt left vaccination site at 1435 and transported to ER.
69 2021-03-04 fast heart rate TACHYCARDIA, NAUSEA STARTING APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF THE 2ND DOSE. ALSO EXP... Read more
TACHYCARDIA, NAUSEA STARTING APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF THE 2ND DOSE. ALSO EXPERIENCED TREMORS GENERALIZED BUT WORSE IN HER HANDS WHICH STARTED APPROXIMATELY 25 MINUTES AFTER INJECTION OF COVID-19 (PFIZER) VACCINE.
69 2021-03-06 chest pain, chest discomfort About 30 minutes after shot I had two streaks of pain across my chest a little heavy feeling for jus... Read more
About 30 minutes after shot I had two streaks of pain across my chest a little heavy feeling for just that minute or two. Then gone and nothing more of anything.
69 2021-03-06 coughing up blood Pain in my lower right side and back. Hives on my upper legs and upper arms. Purple spots on my shin... Read more
Pain in my lower right side and back. Hives on my upper legs and upper arms. Purple spots on my shins. Extreme fatigue resulting in shortness of breath when I walk a very short distance. Coughing up very small traces of blood. Muscle and joint pain. In particular sore abdomen, back and upper shoulders. Pain is sharp when I cough or move a certain way. Sometimes it is just a persistent aching.
69 2021-03-07 chest pain, blood pressure increased Experienced severe chest pain Severe migraine Pain in neck and back. Took ambulance to hospital B... Read more
Experienced severe chest pain Severe migraine Pain in neck and back. Took ambulance to hospital Blood pressure was extremely high
69 2021-03-07 chest pain My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting o... Read more
My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting on Saturday, the day following the vaccination} in a sore right wrist and a much more painful right arm that steadily grew in intensity and spread rather rapidly into my upper torso. By the following day (Sunday, 2/21) my breasts became very sensitive and I had severe pains across my back. This may or may not have been the beginning of a banding type MS exacerbation, but by Monday, 2/22, it was clear that I was experiencing a full-blown and seriously disabling exacerbation. Both legs experienced the tingling and numbness I have had in a prior exacerbation, and by the time I was able to talk to Dr. (my neurologist) on Monday afternoon (2/22), the numbness had progressed upward into my lower abdomen and I was no longer able to stand at all. It appears highly likely that the MS attack was triggered by the response of my immune system's reacting to the discomfort and severe body pains that occurred following the vaccination. I told Dr. of the total loss of feeling and use of both legs and was experiencing a increasing numbness from toes up to abdomen. Before ordering the high doses of corticosteroids used to stop my exacerbation, Dr. sent me to the Emergency Room for testing to make sure I did not have an infection that could be covered up by the steroids. When this testing did not show any such infection, the ER administered an IV infusion of 1 gram of solumedrol, followed by gradually decreasing high oral doses of prednisone. As of this date, numbness has started decreasing and some limited utility of right leg has returned. Still i can no longer stand and perform even the minimal movements to-and-from wheelchair to bed or toilet without substantial physical help (not needed before this exacerbation) from my sole caregiver, my husband.
69 2021-03-07 heart attack Swelling of tongue, throat, face, eyes, nausea I dose from Epipen Swelling came down but then came b... Read more
Swelling of tongue, throat, face, eyes, nausea I dose from Epipen Swelling came down but then came back 911 was called- transported to ER. Given a 2nd dose of Epinephrine en route which caused me to have an immediate heart attack
69 2021-03-07 chest discomfort, heart rate increased a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fa... Read more
a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fast; Granddaughter had covid virus and passed to caller/she tested positive for COVID 19/she was diagnosed with COVID; she was feeling bad; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date: 30Apr2021), via an unspecified route of administration at the right arm on 24Jan2021 07:15 at a single dose for COVID-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. It was reported that the patient's granddaughter had COVID virus and passed to the patient. The 2nd dose appointment scheduled for 14Feb2021. Patient stated she had the first dose of the Pfizer COVID 19 vaccine on 24Jan2021 at 0715AM in the right arm. After that, she found out she got infected with COVID 19. On 01Feb2021, she tested positive for COVID 19. On 28Jan2021 (also reported as on 28Jan20201 or 29Jan2021), she was feeling bad. Her little granddaughter had COVID virus (was infected at the school) and passed it on to her. Now she has been going to different places checking it out and she went to urgent care because her heart was beating fast on 02Feb2021. She had an electrocardiogram and her lungs were okay on an unspecified date. They told her was eligible to get an infusion but she doesn't know what it is. The urgent care clinic told her she could get the infusion but then she can't get the second dose of the Pfizer COVID 19 vaccine. She wants to ask if this is true. She was being offered a monoclonal antibody infusion. When ask if this is the first time to call, she stated she called once before right after she found out that she had the COVID 19 infection to ask if she could still get the second shot. She did report at that time that she had gotten the first dose and then tested positive for COVID 19 and she previously provided product information including the lot number from her vaccine card. She added that her heart has been going very fast and has been having fever on 02Feb2021 for two or three days. It is not as high today as it was before. She does want to get the second dose. The first dose helped her so much. On 04Feb2021 (reported as yesterday), she was checked at urgent care because of heart concern and a bit of pressure in chest. Patient stated she only had a little cough, sore throat and runny nose, but she hasn't experienced any other symptoms on an unspecified date. The patient's weight was 54.43 kg on 01Feb2021. The outcome of the events "fever" and "her heart was beating fast" was recovering, while the outcome of the other events was unknown. Patient was scheduled to receive her second dose on 14Feb2021.
69 2021-03-08 blood pressure increased patient was in observation and stated that she was ahe started to feel flushed. Notified medics and ... Read more
patient was in observation and stated that she was ahe started to feel flushed. Notified medics and vital signs were taken blood pressure was elevated at 197/92, pulse 82 an d oxygen saturation 96%. Patient stated that she had " white coat syndrome" and was nervous. Patient refused further evaluation at the hospital and states that she was feelig well after a few minutes.
69 2021-03-09 chest discomfort Wednesday, the morning after the shot: 101.7 fever and in bed all day; chills/cold; can "feel my ... Read more
Wednesday, the morning after the shot: 101.7 fever and in bed all day; chills/cold; can "feel my skin;" stomach and diet off; bowels off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; slightly headache; low energy; Thursday, the second day after the shot: 99.7 temp; stomach and diet off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; thirsty Friday, day three: stomach and die off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; thirsty Saturday, day four: chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth Sunday, day five: chest and upper back pressure; deliberate taking of a deep breath Monday, day six: chest and upper back pressure; deliberate taking of a deep breath Tuesday, day seven: chest and upper back pressure; deliberate taking of a deep breath Wednesday, day eight: chest and upper back pressure; deliberate taking of a deep breath
69 2021-03-10 palpitations Hands turn red, beginning itching on body and hair and when got home my legs were swolled . At arou... Read more
Hands turn red, beginning itching on body and hair and when got home my legs were swolled . At around 4pm I awoke and my heart was beating haed ans fast, My rate was 200/110,
69 2021-03-10 chest discomfort diaphoretic, leg tremors, fatigued, short of breath, dizziness, chest pressure and weakness, which ... Read more
diaphoretic, leg tremors, fatigued, short of breath, dizziness, chest pressure and weakness, which occurred 10 minutes after injection. Patient went to the emergency department within the Medical Center. Patient had an EKG and blood work. Patients symptoms were worse on exertion. She is followed by pulmonology and has been taking prednisone 40mg daily for the past and Bactrim for prophylaxis. Patient had respiration rate in the 30s, and was saturating well on 3L oxygen which is her baseline. EKG was normal. Patient tested negative for COVID-19 on 3/10/21. Patient was admitted to general medicine floor.
69 2021-03-11 chest discomfort, hypertension 69-year-old F with medical history of hypertension, diabetes on insulin, and hyperlipidemia who expe... Read more
69-year-old F with medical history of hypertension, diabetes on insulin, and hyperlipidemia who experienced headache, burning to the injection side, and chest tightness immediately after her 1st dose of the vaccine. Denies shortness of breath, palpitations, dizziness, or any other symptoms. She did not look in any acute distress, her lungs clear to auscultation bilaterally, cranial nerves 2-12 intact and no pronator drift. Vital signs 98%RA, HR 76 , BP 150/90. She was observed in the medical tent for total of 30 minutes and given water and was reassured. She felt completely asymptomatic prior to discharge and confirmed that her headache, burning side, and chest tired were all completely resolved. She was ambulatory before discharge and was advised to call 911 or go to the nearest emergency room if any she she verbalized understanding and agreed to the treatment plan.
69 2021-03-11 hypotension Hypotension leading to septic shock and DIC. Started 6 hours after injection. Discharged from hos... Read more
Hypotension leading to septic shock and DIC. Started 6 hours after injection. Discharged from hospital on 2/24/21. Left with much worse dementia. Weakness progressed. Now on hospice
69 2021-03-11 fast heart rate, heart attack Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressi... Read more
Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressively worse - endorsed fever, diarrhea, body aches, trouble breathing, lack of appetite. On 3/2/2021 pt and husband presented to ED. Pt's husband stated that pt had become more and more confused since she received the vaccine and that on 3/2 she could not complete her sentences. Temp 101.6 on arrival, tachycardic in 130s, tachypneic in 120s, but not hypoxic. Patient was given acetaminophen on arrival. IV was inserted and patient was given 1 L intravenous fluid replacement as well as 2 g ceftriaxone for broad-spectrum coverage within 3 hours of arrival. Blood work was drawn that shows no leukocytosis but lactic acidosis to 3.3. There are multiple electrolyte abnormalities, hyponatremia 127, hypokalemia 2.8, creatinine 1.01, ALT 59 AST 53, ALP 136, total bili 1.3, lactic acidosis 3.3, troponin 0.02. Patient was given 40 mEq of oral potassium. Additional L of normal saline was given for total of 2 L normal saline bolus. Chest x-ray shows right basilar pneumonia. Also shows pulmonary nodule of which husband was made aware. LFTs are noted be elevated, so biliary ultrasound was obtained that was negative with limit to body habitus. Husband was updated. Azithromycin was added on. Rapid COVID antigen was negative. 3/3/21: Febrile, SOB overnight. Pt more lethargic, trailing off in the middle of sentences and having difficulties following conversation. Continue sepsis protocol, add vancomycin IV to ceftriaxone and azithromycin. Frequent neuro checks. MRCP. Chest pain-free, serial cardiac enzymes from yesterday to demonstrate nonischemic pattern likely type 2 NSTEMI. 2/2 blood cultures from 3/2 positive for Streptococcus pyogenes (Group A). Vancomycin and azithromycin dc'd. 3/11: Discharged from hospital. Patient admitted for acute hypoxic respiratory failure secondary to right basilar community-acquired pneumonia. Blood culture grew Streptococcus pyogenes, patient was initially treated with ceftriaxone and switched to Ancef . repeat blood culture on 03/04/2021 showed no growth. Patient will complete a total 14 day course of antibiotics with amoxicillin from culture negative date. Patient had right-sided pleural effusion, pulmonary consulted and she underwent thoracentesis x2 culture showed no growth, considered parapneumonic effusion. Patient required 2 L continuous oxygen and deemed stable for discharge. She will follow up with Pulmonary in 3 weeks, outpatient chest CT in 4-6 weeks to be ordered by Pulmonary to assess lung nodule and known thoracic aortic aneurysm. PTOT recommended home discharge with VNA. On discharge patient was a febrile and hemodynamically stable. Remained COVID negative throughout.
69 2021-03-12 blood pressure increased Sweaty palms and blood pressure went up within 10 minutes of vaccine but then it started to go down ... Read more
Sweaty palms and blood pressure went up within 10 minutes of vaccine but then it started to go down so I left. I normally have low blood pressure. A few days later I got LOUD tinnitus and some ear popping.
69 2021-03-13 heart rate increased Face and neck swelled up, faster heartbeat, a day later severe bloating, gas, stomach cramps, stom... Read more
Face and neck swelled up, faster heartbeat, a day later severe bloating, gas, stomach cramps, stomach cramps lasted several days
69 2021-03-14 fainting BLURRED VISION AND ALMOST FAINTED THEN RASH BEGAN IN TORSO AND BREAST AREA. NEXT DAY THE RIGHT EYE ... Read more
BLURRED VISION AND ALMOST FAINTED THEN RASH BEGAN IN TORSO AND BREAST AREA. NEXT DAY THE RIGHT EYE GOT REALLY SWOLLEN ALMOST SHUT
69 2021-03-14 body temperature decreased Immediately, I had a cough, which is odd. But I do have intermittent cough, and this may have trigg... Read more
Immediately, I had a cough, which is odd. But I do have intermittent cough, and this may have triggered it. It is not covid but cough of long-standing. The next day I had sore arm, muscle pains, cold body temperature (97.1 F), and wheezing. Wheezing was new and it hurt and worried me. Intense fatigue. Wheezing has resolved but the rest still there and it is 11 days since vaccine
69 2021-03-15 heart rate increased 16 hours after receiving the shot, I woke up with a very rapid heartrate (120). It did slow down so... Read more
16 hours after receiving the shot, I woke up with a very rapid heartrate (120). It did slow down somewhat (to the 90s) after a while. However, sporadically over the next few days, I did feel it was elevated. Later that day, one day after getting the shot, I developed a severe migraine headache--which included nausea and two bouts of vomiting (1 in the late afternoon and one in the evening of March 12th). The headache resolved sometime on Sunday, March 14th although I felt a bit weak and shaky. Currently, five days after receiving the shot, I feel a bit "shaky", and feel that my heartrate is rapid on occasion.
69 2021-03-15 cardio-respiratory arrest, fainting Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders foll... Read more
Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders followed immediately by fainting, cardio-respiratory arrest that required call 911 for emergency transfer to Hospital. She was intubated in the emergency room treated by the doctors, Cardiologist and Intensive care where she was subjected to hypothermia and other treatments due to the serious neurological damage that she presented. No other organ seemed compromised. Never came out of the coma, passing away on February 26, 2021.
69 2021-03-15 loss of consciousness, fainting Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirs... Read more
Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.
69 2021-03-15 blood pressure decreased Delayed anaphylactic reaction - intense flushing of entire body with itching and hives, drop in BP, ... Read more
Delayed anaphylactic reaction - intense flushing of entire body with itching and hives, drop in BP, swelling of tongue
69 2021-03-15 blood glucose increased When probed for are the events worsened improved or still persisting consumer stated "Worsened"; Blo... Read more
When probed for are the events worsened improved or still persisting consumer stated "Worsened"; Blood Sugar went up; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration on 28Jan2021 at single dose, and second dose (lot number: EN6200, expiry date not reported), via an unspecified route of administration on 19Feb2021 at single dose for COVID-19 immunization. Medical history included blood pressure measurement, hypothyroidism (low thyroid), and diabetes mellitus. Concomitant medications included thyroid (ARMOUR THYROID) for hypothyroidism and liothyronine. The patient's blood sugar went up on 02Feb2021. When probed if the event worsened improved or still persisting, the consumer stated "worsened" on an unspecified date. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement:high and thyroid function test: low. Clinical outcome of blood sugar went up was not recovered while unknown for the other event. Information about lot/batch number has been obtained.
69 2021-03-15 palpitations at 10 minutes....throat began to swell and close. At 45 min, face was getting puffy. At 2 hrs - he... Read more
at 10 minutes....throat began to swell and close. At 45 min, face was getting puffy. At 2 hrs - head felt tight. At 3 hrs - heart racing, shaky, but blood pressure was normal.
69 2021-03-16 cerebrovascular accident 2/25 woke up at 7:30 a.m. with fever, chills, and severe body aches all day 2/26 same as previous da... Read more
2/25 woke up at 7:30 a.m. with fever, chills, and severe body aches all day 2/26 same as previous day plus lethargy 2/27 woke up at 3:30 a.m. with SEVERE headache and partial loss of vision Went to ER and they diagnosed me with a moderate stroke and mild cognitive issues with right hemisphere vison loss in both eyes.
69 2021-03-16 chest discomfort, hypertension Day after 2nd injection my blood pressure skyrockets to 200/104 with chest pressure. Admitted to me... Read more
Day after 2nd injection my blood pressure skyrockets to 200/104 with chest pressure. Admitted to medical center. All heart tests EKG, Echo and Stress Test came back normal.
69 2021-03-16 fainting, chest discomfort, palpitations Presents to PCP 2 days after 2nd covid vaccine with fevers, chest heaviness, palpitations, syncope (... Read more
Presents to PCP 2 days after 2nd covid vaccine with fevers, chest heaviness, palpitations, syncope (fell and hit head), swollen lymph node under arm, bilateral ear pain. Sncyope thought to be vasovagal and not related to vaccine. OTC treatment for symptoms.
69 2021-03-18 chest pain HEADACHE/MIGRAINE, DIZZINESS, CHILLS, BODY PAIN, IMPAIRED COGNITION,EARS RINGING, CHEST PAIN,BREATHI... Read more
HEADACHE/MIGRAINE, DIZZINESS, CHILLS, BODY PAIN, IMPAIRED COGNITION,EARS RINGING, CHEST PAIN,BREATHING DIFFICULTIES
69 2021-03-18 blood pressure increased, heart rate increased Increased blood pressure and heart rate. Chills - fever- headache - body aches - sick to my stomach ... Read more
Increased blood pressure and heart rate. Chills - fever- headache - body aches - sick to my stomach - tireness - swollen and red arm at injection site along with some itching. Woke up with these symptoms next day after vaccine. Blood pressure, heart rate, and other symptoms were better by day 2 but swollen arm and redness still persists. Still have a slight headache.
69 2021-03-18 heart rate increased, blood pressure fluctuation crazy blood pressure fluctuations the highest was 188/89/BP was around 159 or 150 then it came down ... Read more
crazy blood pressure fluctuations the highest was 188/89/BP was around 159 or 150 then it came down to 136/71; feeling real jittery; hot flush feeling like an adrenaline rush in her upper chest and arms; heart pounding/highest pulse was 106; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EM5318), via an unspecified route of administration, administered in the left upper arm on 09Feb2021 at 11:00 at a single dose for COVID-19 immunization. Medical history included premature ventricular contractions (PVC) from an unknown date wherein her pulse goes up into the 120s and had to go to the ER. There were no concomitant medications. The patient previously received Pneumovax 23 on 14Jan2021. The patient called about the Pfizer COVID 19 vaccine. The patient had the shot on 09Feb2021 and the 10th she was fine then on 11Feb2021, she started having side effects. She is calling it side effects but what she is describing, she has these episodes periodically but she has not had one in 2 years but it was bad one and it happened 2 days after her vaccine, she is not sure if it was side effect but she doesn't want to mess with it so she wants to tell someone. On 11Feb2021, the reaction started around 1:30 PM. She started feeling real jittery, she was hot flush feeling like an adrenaline rush in her upper chest and arms down to her elbows. She could feel her heart pounding and she had these before but no one seems to know what causes it. She worked with it she was busy doing other things then around 4PM that day it started getting worse. She could tell her blood pressure was getting involved. She started taking her blood pressure, from 4:30 on until 12:30AM she had crazy blood pressure fluctuations the highest was 188/89 and the highest pulse was 106 but it goes up to 188 and then it would be 158, 179, 155, 119, 166 and those are the top number of the blood pressure. Her pulse pretty much stayed high 80s 90s except for the time it was 106. After midnight, her BP was around 159 or 150 then it came down to 136/71 and her pulse was 78 and she slept much better, she slept for 4 hours she woke up feeling like heart pounding but her blood pressure was 125/69 and her pulse was 74. She also has PVC and sometimes they say when she feels her heart pounding and her blood pressure and pulse are fine, they said that is probably PVC. When her blood pressure and pulse goes way up she is miserable. She had it so that her pulse goes up into the 120s with this and she has had to go to ER before. She clarifies her pulse being in the 120s and having to go the ER was in the past, prior to the vaccine. She says no one can figure out what it is. Some said it was anxiety, she sat through a whole program on anxiety and they decided not that is not what it is. But the fact that she hadn't had one of these episodes in 2 years and she had a good sized one 2 days after the vaccine, she had a really hard one that is why she thought she better report it. It has definitely gotten better she still feels jittery and heat flush every once in a while, but her blood pressure is fine. It is 139/74 and pulse 74. She can tell its still there but improved and certainly not uncomfortable. The events did not require a visit to the emergency room or the physician's office but she contacted her doctor's office and she has an online thing with them in a half an hour from the time of the report. The outcome of the event crazy blood pressure fluctuations the highest was 188/89/bp was around 159 or 150 then it came down to 136/71 and heart pounding/highest pulse was 106 was recovering while the outcome of the events feeling real jittery and hot flush feeling like an adrenaline rush in her upper chest and arms was unknown.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event blood pressure fluctuation cannot be excluded. The cardiovascular medical history is likewise a risk factor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
69 2021-03-18 heart rate increased very fatigued; It has mostly remained above 100 all day today. As I sit and type, it is currently 13... Read more
very fatigued; It has mostly remained above 100 all day today. As I sit and type, it is currently 135, significantly higher than normal for sitting and typing.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported), via an unspecified route of administration on the right arm on 03Feb2021 08:30 at single dose for covid-19 immunisation. Medical history included ankylosing spondylitis, osteoarthritis, hypothyroidism, osteoporosis, known allergies: NSAIDs from an unknown date and unknown if ongoing. Concomitant medication included alendronate sodium (ALENDRONATE), arnica montana and thyroid (ARMOUR THYROID). The patient previously took neosporin, dolobid, diflunisal and experienced allergies. The patient was 69 years old when she received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry date not reported) on the right arm on 14Jan2021 08:30 for covid-19 immunisation. The patient reported that they went to bed at 10:30pm last night; very fatigued. At 4:08am on 04Feb2021, tapped them and reported that her heart rate had been above 120 for 10+ minutes while she was lying down. She checked the Heart app and it showed that her heart rate had been in excess of 120 for 2.5 hours while she slept. Her resting heart rate is normally 70 or below. She got up; the heart rate remained elevated for another hour or more, finally dropping below 120 at 5:30am. She was very fatigued (from the high heart rate?; as reported) for several more hours. It has mostly remained above 100 all day today. As she sit and type, it is currently 135, significantly higher than normal for sitting and typing. It was reported that the events occurred on 04Feb2021 at 01:30 am. No treatment was received for the events. The patient did not recover from the events.
69 2021-03-19 palpitations, atrial fibrillation After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shakin... Read more
After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shaking body, had to call 911 , in hospital was diagnose with Atrial Fibrillation, did not have this problem before!! Have to take 4 new medications for the rest of my life!!! I may experience stroke in the future. For a early few days had pain in my left arm. For the next few weeks overall tiredness. strange feelings in my head!!!!
69 2021-03-19 fainting Extreme chills fever101.2 Fainted
69 2021-03-19 chest discomfort, blood pressure increased Sleepy, felt heavy chest, blood pressure up
69 2021-03-20 loss of consciousness passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my hea... Read more
passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head.; Chills; fatigue; nausea; lightheadedness; vertigo; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EM9810) via an unspecified route of administration, administered on the left arm on 26Feb2021 15:15 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate (OS-CAL) and vitamin. The patient previously took BNT162B2 for COVID-19 immunisation (first dose on the left arm at 01:30 PM, lot number: EL 1283); and SHINGRIX vaccine in 2019, codeine and cipro and experienced allergies. On 27Feb2021 03:30 PM, the patient experienced chills, fatigue & then sudden nausea & lightheadedness that resulted in passing out. Unfortunately, the patient fell on a tile floor & hit her head resulting in a 1.5 inch gash in the back of her head. When she went to the ER, it was determined that she now had vertigo (which she never had before) but obviously hard to tell if it was a side effect of the vaccine or from the fall. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events which included CT scan, ekg, chest X-ray, bloodwk (unknown results) and Epley maneuver. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient is not pregnant. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
69 2021-03-21 fainting, chest discomfort I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn re... Read more
I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn red, tightness in the upper part of my body, lips tingling, tightness / swelling in my cheeks and mouth, very severe headache. I was rushed over to ER. Next day still had tingling of lips, felt unwell. By third day, felt better. I had an anaphylactic reaction to the vaccine. Three of my systems were adversely effected. Dr. and others are UNDERREPORTING the anaphylactic reactions cases. Just because I didn't die or an Eppie Pen was not given to me. doesn't mean I should not be included in the statistics.
69 2021-03-21 heart rate increased Rapid heart rate; This is a spontaneous report from a contactable consumer (the patient). A 69-year-... Read more
Rapid heart rate; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9266), via an unspecified route of administration in the right arm on 17Feb2021 12:00 (at the age of 69-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: past history of breast cancer. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient had no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 13:30, the patient experienced rapid heart rate. The clinical course was as follows: About 1.5 hours after having the vaccine (17Feb2021 13:30), the patient's heart was pounding rapidly. It went from around 94-110 BPM (beats per minute) to 138-140 BPM. This continued for about an hour, fluctuating up and down, and finally lowered. She did not know if this was anything to worry about, since she couldn't get a hold of a doctor. Since it lowered, she guessed it might have been just a basic side effect. She didn't have any other adverse effects. No treatment was received for the event. The clinical outcome of rapid heart rate recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
69 2021-03-21 cerebrovascular accident Stroke - globus pallidus area Lost ability to speak and recognize objects. Immediately taken to ER... Read more
Stroke - globus pallidus area Lost ability to speak and recognize objects. Immediately taken to ER and evaluated and TPA given. Results good following drug administration sent home after two days. Some mental affects still.
69 2021-03-21 cerebrovascular accident Stroke; Nasal swab COVID test post vaccination/positive; This is a spontaneous report from a non-con... Read more
Stroke; Nasal swab COVID test post vaccination/positive; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6205, expiry date unknown), via an unspecified route of administration on 11Mar2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination on an unknown date. The patient's concomitant medications were not reported. The patient experienced stroke on 14Mar2021, two days (as reported) after having the vaccine. The event required an emergency room/department or urgent care visit and hospitalization for 2 days on unspecified dates in Mar2021. The patient received treatment for the event stroke and unspecified tests and monitoring was done. The event was also considered as a life threatening illness (immediate risk of death from the event) and has caused disability or permanent damage. The patient had a nasal swab COVID test post vaccination on an unspecified date in Mar2021 with a result of positive. The patient recovered from the event stroke with lasting effects while the outcome of the event nasal swab covid test post vaccination/positive was unknown. No follow-up attempts are possible. No further information is expected.
69 2021-03-22 chest discomfort Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up wi... Read more
Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up with my finger joints stiff, swollen and throbbing with pain (this subsided on day 4) Day 3 - No symptoms Day 4 - Woke up with rash (burning) on right side of my neck, and headache.
69 2021-03-22 heart rate increased Patient had adverse reaction to shot #1 including rash, increased heart rate, nausea so she decided ... Read more
Patient had adverse reaction to shot #1 including rash, increased heart rate, nausea so she decided that she wanted to get Moderna instead of Pfizer. Appointment was scheduled and she received her 2nd shot Moderna. Side effects included 3 days of severe symptoms of fatigue, nausea, vomiting, chills, fever and over all severe body aches. Aside from the above, no other reactions noted from 2 different vaccines. Patient was called and educated.
69 2021-03-23 chest pain Severe pain in spine, neck, chest, and arm. Started about 10 days after the vaccine. Sore throat, la... Read more
Severe pain in spine, neck, chest, and arm. Started about 10 days after the vaccine. Sore throat, lack of sleep, and lack of hunger or thirst.
69 2021-03-24 nosebleed 4d after vaccination patient started experiencing nosebleeds (lasting ~10 minutes with compression) ... Read more
4d after vaccination patient started experiencing nosebleeds (lasting ~10 minutes with compression) and developed petechiae on her hand. Recommended ER for evaluation and laboratory work (CBC/CMP) after discussion
69 2021-03-24 very slow heart rate, lightheadedness About 30 minutes post vaccination the recipient complained of dizziness and lightheadedness. Recipie... Read more
About 30 minutes post vaccination the recipient complained of dizziness and lightheadedness. Recipient was evaluated by an on-site EMT who said vitals were normal with the exception of mild bradycardia. Patient felt close to syncopal episode and so was transported by ambulance to hospital for observation.
69 2021-03-24 hypertension, palpitations Light-headed, dizzy, flushed, hypertension (194/116), Fast heart rate (HR 95), ear swelling. Gave... Read more
Light-headed, dizzy, flushed, hypertension (194/116), Fast heart rate (HR 95), ear swelling. Gave pt 25mg PO diphenhydramine tablet. Called 911, pt brought to emergency room.
69 2021-03-24 chest discomfort Patient came to ems table by staff complaining of chest pressure In the centre of her chest. No sob ... Read more
Patient came to ems table by staff complaining of chest pressure In the centre of her chest. No sob or other symptoms. 4 led ekg show nsr at 90 bpm. Rep 18 spo2 96% b/p157/60. Pt skin color was normal. . Pt sat down on tbe stretcher. After about 10 min pt states the pain has subsided. Pt stats migh have been indigestion. Pt was advised to f/u with pcp. Pt did not want to ge to er.
69 2021-03-24 hypertension, palpitations, chest discomfort Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and c... Read more
Within 30-minutes of vaccination, the patient reported shortness of breath, chills, dizziness, and chest pressure. EMS evaluated the patient on-site. The patient was hypertensive (223/180). EMS administered O2 2lpm via nasal cannula. In the ED, the patient reported they felt flushed with a headache. They remained hypertensive (167/89). ED physician admitted patient to inpatient telemetry unit for 1-day. Discharged with diagnosis of chest tightness with associated SOB and palpitations, reproducible on palpitation, troponin negative and EKG with no acute ST-T wave changes, no arrhythmia noted on telemetry, low likelihood of acute coronary syndrome. Patient was instructed to follow-up outpatient for PET stress test and 2D Echo.
69 2021-03-25 palpitations C/O HEART RACING; SHAKING EPISODE X 3 ; AFTER THIRD EPISODE AGREED TO GO TO ER; AMBULANCE TRANSPO... Read more
C/O HEART RACING; SHAKING EPISODE X 3 ; AFTER THIRD EPISODE AGREED TO GO TO ER; AMBULANCE TRANSPORTED TO HOSPITAL.. SPOKE WITH CASE @0803 ON 3/26/2021; STATES THEY DID NOT KEEP HER. OBSERVED HER IN ER FOR A WHILE THEN DISCHARGED HER. NO FURTHER PROBLEMS. FINE TODAY
69 2021-03-25 hypertension Dizziness (h/o vertigo). BPs 142/75 (pulse 87), 135/72 (pulse 87). O2 sats 96%.
69 2021-03-25 blood glucose increased Have had elevated sugar levels a few days after having the first dose. Have just seen my PCP to take... Read more
Have had elevated sugar levels a few days after having the first dose. Have just seen my PCP to take necessary steps
69 2021-03-25 heart attack, chest pain, cardiac arrest Vaccine 3/2/2021.Presented to ER 3/25/2021 with chest pain and found to have acute MI with completel... Read more
Vaccine 3/2/2021.Presented to ER 3/25/2021 with chest pain and found to have acute MI with completely occluded left main coronary artery with clot causing cardiac arrest, cardiogenic shock. Currently Critically ill, intubated, high risk mortality.
69 2021-03-26 platelet count decreased, low blood oxigenation This is a 70 year old female with paroxysmal atrial fibrillation (anticoagualted on Eliquis), obstru... Read more
This is a 70 year old female with paroxysmal atrial fibrillation (anticoagualted on Eliquis), obstructive sleep apnea (uses CPAP), mitral valve regurgitation, remote tobacco use, hypertension and dyslipidemia who presents to the ED for worsening dyspnea, cough, subjective fever, chills and body aches that have been ongoing for the past several days. The patient indicates that her dyspnea is exacerbated with exertion but she denies chest pain, pleuritic chest pain, leg swelling or calf pain. She mentions that she has received both of her COVID-19 vaccines (Pfizer); the first immunization was on 02/25 followed by her second immunization which took place eight days ago on 03/18. She is not confident that she has had any contact with a known sick or definitive COVID-positive individual recently. Of note, the last documented incidence of testing for COVID-19 was performed on 10/31/2020 after the patient was seen at a Clinic after a exposure for a COVID-positive individual. Testing at that time had resulted negative. To her knowledge, she states that she had, in fact, tested positive for COVID-19 in late fall of 2020, but she was not hospitalized. Yesterday (3/26/2021), she was evaluated at a Pharmacy where she was testing for COVID-19 which has since resulted positive. The patient denies any other acute symptoms of illness. In the ED, the patient was found to have acute respiratory failure with hypoxemia and pneumonia due to SARS-CoV-2 infection. Review of Systems Constitutional: Positive for chills, fatigue and fever. Negative for activity change. Respiratory: Positive for cough and shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for arthralgias and myalgias. Negative for gait problem. Neurological: Negative for syncope. All other systems reviewed and are negative. Vitals Blood pressure 159/79, pulse 65, temperature 36.4 °C (97.5 °F), temperature source Oral, resp. rate 18, height 1.6 m (5' 3"), weight 107 kg, SpO2 98 %. Physical Exam Vitals reviewed. Constitutional: General: She is awake. She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is morbidly obese. She is ill-appearing. She is not toxic-appearing. Interventions: Nasal cannula in place. HENT: Head: Normocephalic and atraumatic. Nose: Congestion present. Mouth/Throat: Mouth: Mucous membranes are dry. Pharynx: Oropharynx is clear. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Decreased breath sounds present. Comments: Diminished breath sounds in all lung fields. Occasional cough. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Behavior: Behavior is cooperative.
69 2021-03-27 pallor I initially had 2 days or so of feeling very ill. Then ok for 5 days. Then second round of reaction... Read more
I initially had 2 days or so of feeling very ill. Then ok for 5 days. Then second round of reaction started. Intense pain and swelling of right side of neck for 3 days. Also left wrist unable to use. Pale, ill. Vital signs ok. Then on 3/8, pain switched to left side of neck and upper back. 3/10, right neck again with swollen lymph nodes bilateral. 3/11 back of neck and upper back hurts. Intense. Could not sleep. 3/12 pain in upper quads and hips, mid pack. Feeling freezing cold. Temp ok. Called my Dr. Right side of neck continued to hurts even now (3/28/2021) but at least I can function now. I no longer feel sick, brain fog, cold. So greatly improved but not normal. Reaction has lasted a month. Vaccine number one resulted in 2 days feeling ill with upper back pain, chills but only a few days. First night vomited, passed out. First vaccine reaction was frightening but was short lived. I am a retired RN.
69 2021-03-27 ischaemic stroke, platelet count decreased, blood clot, cerebral haemorrhage Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and ... Read more
Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage
69 2021-03-27 fainting mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; jo... Read more
mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
69 2021-03-28 fibrin d dimer increased 03/23/21: Patient presented and was admitted through the ED forof breath that has been present for a... Read more
03/23/21: Patient presented and was admitted through the ED forof breath that has been present for a week, getting worse with productive cough of whitish sputum's but in large amounts throughout the day. PMH significant to COPD. Stated she is been doing her neb treatments without improvement. Has had some constipation and left lower quadrant abdominal pain. on day of admission, chest x-ray showed bibasilar atelectasis with possible pneumonia. Rapid Covid 19 came back positive. Her D-dimer was elevated. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
69 2021-03-29 palpitations About 3 minutes after receiving vaccine, my heart started racing . It lasted about 10 minutes. I fel... Read more
About 3 minutes after receiving vaccine, my heart started racing . It lasted about 10 minutes. I felt slightly light headed for the first 5 minutes after, as well.; About 3 minutes after receiving vaccine, my heart started racing . It lasted about 10 minutes. I felt slightly light headed for the first 5 minutes after, as well.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6202), via an unspecified route of administration on 25Feb2021 at 15:00 (at the age of 69-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included hiatal hernia, gastroesophageal reflux disease, hypertension, atrial fibrillation, dilated aorta, osteoarthritis, asthma. The patient is allergic to tea tree oil and reports an allergy to shellfish about 20 years ago. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rivaroxaban (XARELTO), atenolol (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN) all from unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that on 25Feb2021, about 3 minutes after receiving vaccine, her heart started racing. It lasted about 10 minutes. She felt slightly light headed for the first 5 minutes after, as well.T he patient did not receive any treatment for the events. The clinical outcomes of the events heart racing and lightheaded were reported as recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
69 2021-03-29 loss of consciousness Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or w... Read more
Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or walk, altered vision (white picasso slides),
69 2021-04-01 haemoglobin decreased 3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal... Read more
3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal swab was positive for SARS-CoV-2 and she was diagnosed with COVID-19. 3/17 She presented to ED w/ cough, HA, weakness and decreased appetite. Room air pulse ox was 88%. She was found to have bilateral infiltrates on CRS and was hyponatremic. She was admitted to the hospital on oxygen and decadron.. On 3/18 she was weaned off oxygen. She was discharged to home on 3/19 to complete a 10 day course of decadron.
69 2021-04-01 heart rate increased face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneou... Read more
face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration, administered in right arm on 05Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and stroke. The patient is not pregnant. It was not sure if there were known allergies. The patient did not receive other vaccine within 4 weeks prior to the COVID vaccine but took other medications in two weeks (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medication. On 05Mar2021, within one hour of the vaccine, the patient experienced face numbing burning, sweating, fast heart beat and numbness on face that will not go away all day every day since the vaccine. The events resulted in Emergency room/department or urgent care and eventually hospitalization on an unspecified date for 2 days. It was unknown if treatment for the events were given. The patient underwent COVID test post vaccination via Blood test/ CBC differential on 05Mar2021 and was negative. The outcome of the events was recovered with sequelae on an unspecified date in Mar2021. Information about lot/batch number has been requested.
69 2021-04-05 arrhythmia, heart rate increased On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain. A ... Read more
On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain. A few days later I noticed I had extreme shortness of breath. I went to see my PCP on or about 3/31. He listened to my heart and discovered a rapid heartbeat. He then took an EKG. He wanted to put me on lifetime meds immediately. I was in shock because I truly believe this is a reaction to the COVID vaccine. I have never had arrhythmia. In fact, I had a wellness visit with the Dr. about 3 months previously and all was good. I have been seeing him for four years since I moved. He does not think my new diagnosis is related to a vaccine reaction, but I find it highly suspect that 4 other women in my large circle of friends also have AFIB after 2nd shot. I spent Easter in the ER and they pumped Metoprolol in my bloodstream. I did not stay in the hospital that night. I went to see the Dr. on Monday morning on 4/4. He prescribed Metroprolol 25 mg and Xarelto 20 mg IMMEDIATELY. I picked up the meds and started this regimen. In speaking with other women, I believe this terrible diagnosis is a direct result as a reaction from the vaccine.
69 2021-04-06 arrhythmia, heart rate irregular If she laid her arm on it, it was painful on the left side where she got the injection between her l... Read more
If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla; couldn't go back to sleep; very tired; weak; She had the lump and that was in the lymph node; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; irregular heart beats; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; baseball sized lump. It was hard/where she got the injection; It looked like it was connected to the breast because it was so huge.; Fever blister; heart beating so out of rhythm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 at 12:20 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing coeliac disease; hypothyroidism, is diabetic and has irregular heartbeat from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for hypothyroidism; hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN/HCTZ MYLAN) taken for blood pressure measurement; metformin, glipizide and pioglitazone hcl taken for diabetes mellitus; acetylsalicylic acid (ASPIRIN 81) taken for thrombosis; metoprolol taken for heart rate irregular, cyanocobalamin (VIT B12) taken for an unspecified indication, all from an unspecified start date and ongoing; famotidine, rosuvastatin, vitamin d2, vitamin d3 and potassium, all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6198, NDC: 59267-1000-1, expiry: unknown) on 27Feb2021 at 1:40PM for COVID-19 immunisation. The patient got her last shot on 18Mar2021. The first day was fine. She woke up the next morning at three or four with her heart beating so out of rhythm it was crazy. It took almost the whole day. She called her cardiologist and couldn't get into them and she didn't want to go to the ER. She didn't have a way to prove any of that. She also got a baseball sized lump. It was hard. If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla. It extended underneath the axilla. She wasn't able to get in with the cardiologist because she waited to late in the day. She couldn't get off the couch that day because her heart was so out of rhythm. She was very tired and wanted to just lay down. She hates going to the hospital. She doesn't want to go to the hospital. She has a history of irregular heartbeats. She should have gone in and had an EKG. She has pictures of the lump if those are needed. HCP information: Her doctor had said if she had anything like any abnormal heart beats to come in and get an EKG. She also had a fever blister on 22Mar2021 that she hasn't had in years and was asking if this influences her immune system. She had the lump and that was in the lymph node and now a fever blister on the top lip. Heart beating so out of rhythm: it lasted all that day. She took a nap after she talked to the doctor's office and slept for several hours. When she woke up it was kind of back in rhythm, but it was going in and out. It wasn't as frequent as it was prior to nap. Prior to the nap it was almost continuous. It slowed down a lot on the 19Mar2021 and was gone by 20Mar2021. Outcome of event: She has PAC's and PVC's anyway. That is why she follows up with the cardiologist. They haven't been so out of rhythm as they were after the vaccine. She couldn't go back to sleep. She still has them occasionally and that is kind of normal for her. She was weak and tired. Baseball sized lump: it has gone down. She took pictures to show her friends who were all getting the shots. It is gone now. It might have started on 20Mar2021. She woke up with the lump on Saturday. She has recovered completely. Her daughter said she needed to get it checked out. Reporter had heard of a lump on the breast was a side effect. It looked like it was connected to the breast because it was so huge. Seriousness criteria: It was irritating because it was so big. It was painful if she put her arm down. It was like her breast were engorged. Causality: Heart beating so out of rhythm: she hasn't had it that bad, so she thinks it was. She had it a long time ago, maybe once before, but it never lasted that long or took her down like that. She is not the only one that has had the complaint of irregular heartbeats. She put on social media what she experienced and how weak she got. Several friends said that happened to them as well. She doesn't know their history. Reporter declined to do a report on her friends. That was another reason she didn't go to the hospital. She thought it was a normal side effect. She thinks she found on her paperwork about the lump in the lymph nodes. The patient underwent lab tests and procedures which included electrocardiogram: unknown results and heart rate: irregular on an unspecified date. The outcome of the event fever blister was not recovered, while of the rest was unknown. Reporter seriousness for heart beating so out of rhythm was reported as disabling.; Sender's Comments: Based on the information currently available and the plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events 'heart beating so out of rhythm ', 'baseball sized lump (where she got the injection/It looked like it was connected to the breast because it was so huge)' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
69 2021-04-06 fainting Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report... Read more
Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN9581), via an unspecified route of administration in left arm on 02Mar2021 13:30 (at the age of 69-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's first dose of bnt162b2 (lot not reported) (at the age of 68-years-old) in left arm on 01Feb2021 at 14:00 for Covid 19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have other vaccines within 4 weeks prior to the COVID vaccine. Medical history included mild syncope episodes and pacemaker. The patient had no allergies to medications, food, or other products. Concomitant medications included alondranate, calcium, metropolol and an unspecified multi vitamin. The patient experienced arm soreness in the first 24 hours on 02Mar2021. Mild syncope and low grade fever 20 days after dose 2 (on 21Mar2021 at 13:00). The treatment received for the adverse events was paracetamol (TYLENOL). The outcome of all events was recovered on 03Mar2021 for pain in extremity and in Mar2021 for the rest of the events.
69 2021-04-06 pulmonary embolism Started having shortness of breath on Tuesday, 9 March 2021. Continued 10 March 2021. Admitted to lo... Read more
Started having shortness of breath on Tuesday, 9 March 2021. Continued 10 March 2021. Admitted to local hospital. Tests revealed bilateral pulmonary embolism. On Heparin drip until released 12 March 2021 on Eliquis. Difficulty breathing on Saturday, 13 March 2021. Diagnosis elevated white blood count from 9000 to 14000. Tests done. Released with antibiotics and pain meds. Nothing since then.
69 2021-04-06 loss of consciousness Vertigo; nausea; vomiting; diarrhea; loss of consciousness; inability to control limbs; unable to op... Read more
Vertigo; nausea; vomiting; diarrhea; loss of consciousness; inability to control limbs; unable to open eyes and focus; unable to open eyes and focus; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, lot number: EN6204), via an unspecified route of administration in the Left Arm on 20Mar2021 09:30 AM (received at the age of 69-years-old) at a single dose for COVID-19 immunization. The vaccine was administered at a Pharmacy or Drug Store. The patient did not receive any other vaccine within four weeks prior to receiving BNT162B2. The patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus. She had no known allergies. The patient had no prior history of COVID-19. Concomitant medications included dulaglutide (TRULICITY), insulin degludec (TRESIBA), atorvastatin calcium trihydrate (ATORVASTATIN [ATORVASTATIN CALCIUM TRIHYDRATE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), and losartan potassium (LOSARTIN). On 21Mar2021 07:30 AM, the patient experienced vertigo, nausea, vomiting, diarrhea, loss of consciousness, inability to control limbs, unable to open eyes and focus. The reported adverse events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for one day. Therapeutic measures were received as a result of reported adverse events; Medicine for nausea, CT scan, IV. Outcome of the events was recovering. The patient was tested for COVID post vaccination on 21Mar2021 through nasal swab with result of negative.
69 2021-04-07 chest pain a week after both COVID-19 vaccinations (Pfizer) patient had sudden onset of shortness of breath and... Read more
a week after both COVID-19 vaccinations (Pfizer) patient had sudden onset of shortness of breath and chest pain with extreme fatigue and malaise. This happened for 3 days after 1st vaccine. Recovered 90%. Same symptoms onset a week after 2nd COVID-19 vaccine but symptoms were a little worse and did not resolve
69 2021-04-09 low blood platelet count, platelet count decreased, nosebleed Immune thrombocytopenia purpuria; bleeding of gums, nose, skin pricks; bleeding of gums, nose, skin ... Read more
Immune thrombocytopenia purpuria; bleeding of gums, nose, skin pricks; bleeding of gums, nose, skin pricks; bleeding of gums, nose, skin pricks; platelet count of 1000; This is a spontaneous report from a contactable nurse reported for herself. This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number ELU266), via an unspecified route of administration at single dose in left arm on 20Feb2021 12:45 for COVID-19 immunisation. Medical history included allergies to medications penicillins, ceclor, statins, environmental; diabetes; hypertension; asthma; gastrooesophageal reflux disease. The vaccine was administered at Health Clinic. Concomitant medications included rabeprazole, clonazepam, montelukast, venlafaxine hydrochloride. On 22Feb2021, the patient experienced immune thrombocytopenia purpuria, bleeding of gums, nose, skin pricks, platelet count of 1000. Therapeutic measures were taken as a result of the events included steroids, IVGM, platelets, PRBC, iron, antibiotics. The outcome of the events was recovering. The patient was hospitalized and condition was life threatening. The patient underwent lab tests and procedures which included platelet count: 1000 on 22Feb2021, SARS-CoV-2 test: negative on 07Mar2021.; Sender's Comments: A contributory role of the vaccine BNT162B2 to reported events cannot be excluded based on plausible temporal relationship and lack of alternate explanation at this time. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
69 2021-04-09 blood clot blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee d... Read more
blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; blood clot in the leg; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN3248, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 16Feb2021, 15:30 PM at a single dose for covid-19 immunisation (age at vaccination was 69 years). Medical history included blood pressure and thyroid. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine, valsartan, furosemide, acetaminophen. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 16Feb2021, 3 hours after the patient received the vaccination at 18:30 the patient's left leg from the knee down started to swell, got really hard and became very painful. She could hardly walk and afterwards the pain was so intense that she went to the doctor. Doctor took X-rays of her left leg on 16Feb2021, then he diagnosed her with blood clots. He gave the patient 2 heparin shots and immediately sent her to the hospital for a deep vein ultrasound on 16Feb2021. The results showed blood clot in the leg. The patient was prescribed medication and sent home. Her leg continued to be rock hard and painful. On 02Mar2021, the patient was sent for a blood panel work up. There was no improvement. On 08Mar2021, the doctor sent her for a lung CT scan. On the same evening, the patient was called to the doctor's office and was sent to ER immediately as the results showed blood clot in the lung. The patient's dose of Eliquis was doubled. This has now been going for 5 weeks, the patient had not been without pain during this time. Her left leg hardness had gone down a little but was still twice the size of her right leg, knee was huge. The swelling never goes down, not even at night. No covid prior vaccination and no covid tested post vaccination was reported. This case was reported as serious. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
69 2021-04-12 low platelet count Sudden after 19 days of the vaccine severe abdominal pain and facial swelling, abdominal distentio... Read more
Sudden after 19 days of the vaccine severe abdominal pain and facial swelling, abdominal distention , i noticias facial swelling around parotids and subliminal área, no fever they take me to emergency, the pain was very intente 10/10.
69 2021-04-12 loss of consciousness, fainting, chest discomfort Tightening in the chest; Feeling dizzy; Thought she was going to pass out, faint; Thought she was go... Read more
Tightening in the chest; Feeling dizzy; Thought she was going to pass out, faint; Thought she was going to pass out, faint; Not breathing real well; Sick; Needed magnifier to read small writing on card; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6204; Expiration date were not reported) on 24Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included low blood pressure; and used to pass out. The patient had unspecified concomitant medications ("fewer pills"). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6206; Expiration date was not reported) on 03Mar2021 for COVID-19 immunization. On 24Mar2021, the patient thought she was going to pass out and faint; was not breathing real well; and was sick. On 29Mar2021, the patient had tightening in the chest; and was feeling dizzy. In Mar2021, the patient needed a magnifier to read small writing on card. It was unknown if the patient had received treatment for the events. The outcome of the events was recovering for 'thought she was going to pass out and faint', 'tightening in the chest' and 'feeling dizzy'; was recovered in Mar2021 for 'not breathing real well'; and was unknown for 'sick' and 'needed magnifier to read small writing on card'. Follow-up action is needed. Further information is requested.
69 2021-04-13 pulmonary embolism Weakness in left leg, blod clots in lungs, severe headaches continuing I went to emergency on Febru... Read more
Weakness in left leg, blod clots in lungs, severe headaches continuing I went to emergency on February 23, 2021 where I treated for weakness in left leg and was admitted to hospital where I received treatments for a double pulmonary embolism on March 1.
69 2021-04-15 deep vein blood clot Patient developed left leg pain and swelling a few days after receiving her second Pfizer COVID19 va... Read more
Patient developed left leg pain and swelling a few days after receiving her second Pfizer COVID19 vaccination. She was seen in the ER and found to have extensive iliofemoral DVT of the left leg. She was taken for a venogram and thrombectomy and then started on Eliquis.
69 2021-04-17 hypertension, atrial fibrillation A-Fib caused by thyroid issues, potassium too high and/or blood pressure being too high. Had never... Read more
A-Fib caused by thyroid issues, potassium too high and/or blood pressure being too high. Had never had thyroid issues or any problems with potassium. Had no blood pressure issue since on medication.
69 2021-04-17 hypertension, palpitations heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; ... Read more
heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; This is a spontaneous report from a . A contactable consumer (reported for herself). The 69-year-old female patient received first dose BNT162B2 (Pfizer Covid-19 Vaccine Lot Number: EP7534 and Expiry date: Unknown) via an unspecified route of administration on left arm at a SINGLE DOSE on 18Mar2021, for COVID-19 immunization. Medical history and concomitant medication were not reported. On 18Mar2021 (the night she received the Pfizer Covid Vaccine, dose one) she woke with her heart pounding (heart palpitations), slight headache, muscle aches, and left arm hurt. When she went to the doctor, on an unspecified date in Mar2021, they took her blood pressure, and it was very high. It was stated that she went to primary care physician and then she was sent to a Cardiologist. On 26Mar2021, she underwent electrocardiogram and echocardiogram, results were normal for both the investigations. On the same day 26Mar2021, she also had Holter monitor test done (electrocardiogram ambulatory) however the results were pending. On 20Mar2021, the patient recovered from the events of slight headache, muscle aches, left arm hurt and high blood pressure, the outcome of the event of pounding heart was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
69 2021-04-24 hypertension dizziness; high blood pressure/ at 175/110 when normal BP is at 120/70; swelling of tongue/ tongue s... Read more
dizziness; high blood pressure/ at 175/110 when normal BP is at 120/70; swelling of tongue/ tongue swelled but did not close up; felt pretty sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient was vaccinated at a clinic. Medical history included Lyme disease, bell's palsy and neurological pain all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported that she had her first dose of the PFIZER BIONTECH COVID19 vaccine on 02Mar2021 (reported as a month ago). Also seeking assistance if we had any study as to patients who participated in the clinical trial with co-morbidity specifically to that of the Lyme disease. The patient also reported that she had "bad reaction" towards the vaccine that lead her HCP to decide that she should no longer take the second dose of the vaccine. The patient said prior to this that she had Lyme disease, bell's palsy and some neurological pain. Also severe adverse events she experienced immediately after taking the first dose (02Mar2021) are dizziness for many hours, high blood pressure taken by paramedic to be at 175/110 when normal BP is at 120/70. Also experienced swelling of tongue after 15-20 mins post vaccination and felt pretty sick after days after. Also she mentioned that she can't have epinephrine for her severe adverse reactions to the vaccine. The patient was recommended not to take the second dose of the vaccine as she had severe adverse reaction during her first dose. The patient is asking assistance if she can be issued a certificate or a form that would state this for the purpose of international travels. The patient also inquires on any studies on the covid-19 vaccine and Lymes disease, as she had Lymes disease several years ago and had bells palsey, states she reacts to vaccines badly, the patient had her first dose of the covid-19 vaccine on 02Mar2021 had immediate dizziness for many hours, blood pressure was elevated, tongue swelled but did not close up, and cannot have epinephrine and was advised not to have the second dose of the vaccine. The patient also needs to travel overseas to visit with her mother and is asking if there is a waiver or something else she will need in order to travel. The outcome of the events was unknown. Information on Lot/Batch number was not available. No further information is expected.
69 2021-04-24 nosebleed nose bleeds after 2nd dose of the shots for about a week; This is a spontaneous report from a Pfizer... Read more
nose bleeds after 2nd dose of the shots for about a week; This is a spontaneous report from a Pfizer-sponsored programs, COVAX US Support. This is a report from a contactable consumer (registered dietician reporting on herself). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), was received on 31Dec2020, lot number EL0140 for COVID-19 immunization. Medical history included immunodeficiency from an unknown date and unknown if ongoing (she was informed she may not be able to build antibodies) and splenectomy (her spleen was removed 30-35 years ago). The patient's concomitant medications were not reported. The patient experienced nose bleeds after 2nd dose of the shots for about a week in Jan2021 with outcome of recovered in 2021. States the nosebleeds started a couple of days after the vaccine and she had the nose bleeds for a week. No treatment was received. No follow-up attempts are needed. No further information is expected.
69 2021-04-26 blood clot blood clot in my lungs/Multiple blood clots; Pains; This is a spontaneous report from a contactable ... Read more
blood clot in my lungs/Multiple blood clots; Pains; This is a spontaneous report from a contactable consumer. This 69-year-old female consumer reported for herself that: Patient characteristics: Weight (kg): 102.97 Height (cm): 165 Sex: Female Relevant medical history and concurrent conditions: Structured information (Patient episode name): Hypertension Patient Medical comments: Verbatim: Hypertension Reaction(s)/Event(s): Reaction/event as reported by primary source: Blood clot in my lungs within the first 2 weeks after the second shot Reaction(s)/Event(s): Reaction/event as reported by primary source: Hospitalization Reaction/event in MedDRA terminology (LLT): Hospitalization Reaction/event MedDRA term (PT): Hospitalisation Reaction(s)/Event(s): Reaction/event as reported by primary source: Pains Results of tests and procedures for investigation of the patient: Test: CTA scan More information available (Y/N): No Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: Covid-19 Vaccine Batch/lot number: ER8732 Date of start of drug: 30Mar2021 Action(s) taken with drug: Unknown Drug(s) Information: Characterization of drug role: Concomitant Proprietary medicinal product name: Lisinopril HCTZ Dosage text: 20-25 mg Tablet Indication for use in the case: Hypertension Narrative case summary and further information: Case narrative: Selected Report Type: Initial Patient Ethnicity: (Ethnicity withheld) Is the patient also the reporter? Yes Reporter type: Consumer or other non-health professional Reporter telephone: (Phone no withheld) Primary / Prescribing Healthcare Professional Info Dates for Blood clot in my lungs within the first 2 weeks after the second shot.: (From: Unspecified To: Unspecified) Dates for Hospitalization: (From: Unspecified To: Unspecified) Dates for Pains: (From: Unspecified To: Unspecified) Is Covid-19 Vaccine a Pfizer product? Yes Covid-19 Vaccine manufacturer: Unspecified Dates for Covid-19 Vaccine: (Start: 30Mar2021 Stop: Unspecified) NDC number of Covid-19 Vaccine: Unknown UPC number of Covid-19 Vaccine: Unknown Expiry Date of Covid-19 Vaccine: 31Jul2021 Other Products: Yes Dates for Concomitant Products Lisinopril HCTZ: (Start: Unspecified Stop: Unspecified) Patient History: Yes Patient history: Hypertension (From: Unspecified To: Unspecified) Investigation Assessment: Yes Investigation: CTA scan (Date: Unspecified, Result / Units: ) Additional Context: Consumer stated, "I could not follow on the parts. So may be should have done certainly but I am not technically astute. So, I wanted to report that I just had the second Covid-19 test and as a experience in emergency room discovery of blood clot in my lungs within the first 2 weeks after that second shot. So, I wanted to report that. Is this the place I do that?" When paraphrased, consumer stated, "Multiple blood clots." Start date of event (Multiple blood clots.): Consumer stated, "10Apr2021. I should probably say that the pains were 09Apr. I went in the emergency room on the 10th. So, I am not sure which day." Treatment :Consumer stated, "Yes, I went To the emergency room and was kept in the hospital and then I saw my own Doctor just today who is going to help me try to determine what is going to happen next ? I was released by the hospital." Details of hospitalization: Duration of hospitalization: 24 hrs. (overnight) Date of Admission:10Apr2021 Date of Discharge:11Apr2021 Lab work: Consumer stated, "They did lab. work while in the emergency room and in the hospital. They did Chest CTA scan." This is a spontaneous report from a contactable consumer. A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation at age of vaccination 69-year-old. Medical history included hypertension from an unknown date. Concomitant medication included hydrochlorothiazide/lisinopril (LISINOPRIL HCTZ) taken for hypertension, start and stop date were not reported. The patient experienced blood clot in my lungs/multiple blood clots (thrombosis) (hospitalization) on 10Apr2021 with outcome of unknown , pains (pain) (hospitalization) on 09Apr2021 with outcome of unknown. The patient was hospitalized for blood clot in my lungs/multiple blood clots (thrombosis) from 10Apr2021 to 11Apr2021. The patient was hospitalized for pains (pain) from 10Apr2021 to 11Apr2021. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on , laboratory test: unknown results on . The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of blood clot in my lungs/multiple blood clots (thrombosis), pains (pain).
69 2021-04-27 blood pressure fluctuation, blood pressure decreased blood clot in her lung; Shortness of breath; blood pressure dropped extremely low; blood pressure fl... Read more
blood clot in her lung; Shortness of breath; blood pressure dropped extremely low; blood pressure fluctuates; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in the left arm on 17Mar2021 at the age of 69-years-old as single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on 24Feb2021 (Batch/Lot number was not reported) at the age of 69-years-old for COVID-19 immunization. On 07Apr2021, the patient experienced shortness of breath and blood dropped extremely low. On 08Apr2021, the patient experienced blood clot in her lung. And on Apr2021, the patient experienced blood pressure fluctuates. The patient had her final Pfizer Covid vaccine on 17Mar2021. The patient reported that she had to go to the hospital for shortness of breath and her blood pressure dropped extremely low. She stated that they did tests and found out she had a blood clot in her lung. The patient reported that she came home Sunday evening and took the drip thing out and started her on blood thinner that started with an E (as reported). The patient stated that she was told her cardiologist told her to report this. The patient wanted to know if there have been any other reports called in about people calling in with blood clots. The patient was hospitalized due to events shortness of breath, blood dropped extremely low, and blood clot in her lung from 08Apr2021 to 11Apr2021. The patient reported that her blood pressure fluctuates. She stated that it was better than when she was in the hospital. They gave her the drip. The patient reported that her values did come down and this was the only thing they could go by. The outcome of the events shortness of breath and blood pressure dropped extremely low was recovering. The outcome of the events blood clot in her lung and blood pressure fluctuates was unknown.
69 2021-04-27 blood clot blood clot; lymphadenopathy; unable to walk without a cane; her left leg swelled up dramatically; pa... Read more
blood clot; lymphadenopathy; unable to walk without a cane; her left leg swelled up dramatically; painful leg; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (at the age of 69-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient received Pfizer shot a few weeks before reporting. Within 3 hours her left leg (she was inoculated on the left side) swelled up dramatically - - it was painful. Subsequently - a doctor discovered numerous blood clots in that leg; then a blood clot in one of her lungs. She was being treated but the lymphadenopathy has not subsided in her leg and she was now unable to walk without a cane. Lymphadenopathy was not resolved; the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
69 2021-04-28 pulmonary embolism Pulmonary embolism; tested positive for Covid/shortness of breath/severe cough/headache; tested posi... Read more
Pulmonary embolism; tested positive for Covid/shortness of breath/severe cough/headache; tested positive for Covid/shortness of breath/severe cough/headache; This is a spontaneous report from a contactable nurse (patient). The nurse reported similar events for herself and her daughter. This is the first of two cases. A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), the first dose administered in the right arm on 14Mar2021 (Batch/Lot Number: EN6208) and the second dose administered in the left arm on 03Apr2021 at 10:45 (Batch/Lot Number: ER8737), both intramuscular as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure both diagnosed 5 years ago, GERD and hypercholesteremia, all ongoing. The patient was a former smoker but has been smoke-free for 15 years. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for hypercholesterolaemia from an unspecified start date and ongoing; lisinopril (manufacturer unknown) taken for high blood pressure from an unspecified start date and ongoing; metformin (manufacturer unknown) taken for diabetes from an unspecified start date and ongoing and omeprazole (manufacturer unknown) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. The patient did not have any prior vaccinations within 4 weeks of the COVID vaccine. The patient reported that she and her daughter had their second dose of the vaccine on 03Apr2021. The patient tested positive for Covid. The patient developed shortness of breath on Sunday, 11Apr2021, and ended up with a pulmonary embolism. The patient doesn't know if she was possibly infected before they got the second vaccine and were asymptomatic and unknown or did they get infected when got they got the vaccine with thousands of other people. At the time of the report, the patient was mostly resolved and they are all home. She became short of breath, had severe cough and headache and she went to the ER and on the CAT scan they discovered she had a small pulmonary emboli. She was hospitalized from 11Apr2021-12Apr2021. The patient was given Eliquis and monoclonal antibodies as treatment for the events. The patient stated that she will be on Eliquis for the next month because of the pulmonary embolism. The patient did not need any additional therapies for COVID-19. The patient did not have any pre-existing diseases that worsened during the SARS-CoV2 infection. The outcome of the event 'tested positive for Covid/shortness of breath/severe cough/headache' was not recovered while the outcome of the event pulmonary embolism was recovering. The relatedness of the suspect drug to the reactions was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears reasonable that the suspect drug did not contribute to the development of the reported event pulmonary embolism, that most likely was related to the concurrent development of COVID-19. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021413236 same reporter and drug, similat event, different patient
69 2021-04-28 loss of consciousness blanked out and fell; blanked out and fell; This is a spontaneous report from a contactable consumer... Read more
blanked out and fell; blanked out and fell; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left upper arm on 15Apr2021 16:38:53 (Batch/Lot Number: EW0158) (age at vaccination: 69-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, coronary artery disease, blood cholesterol, Hay fever and diabetics. The patient's concomitant medications were not reported. The patient experienced blanked out and fell on 15Apr2021. The patient got the vaccine on 15Apr2021 and they did it in her car and she waited 30 minutes and was fine. The caller was out and went into the bank and on the way out she did not know what happened. The caller got to where she went blank and fell on her face on the floor. She drove herself home. She got a daze and then she was down. The caller didn't get unconscious. The caller got up and didn't have to go to the hospital. This was within an hour of getting the vaccine. Caller states that she shrunk but was now 5 feet 3 inches. The caller mentions that she used to give injections for diabetics and as a rule they wiped the skin with alcohol before administering it. The lady administering the covid vaccine already had the vaccine into the syringe and the person administering it did not use alcohol. The vial with the rubber piece, the caller knows that they used to always wipe it off with alcohol and knock out the air bubbles in the vial. The caller is unsure if there were air bubbles in the syringe because she didn't see it being drawn up. This event was all outside in the car. Caller states they gave her a paper on the vaccine, it says they put some type of medication in the vaccine that has cholesterol in it. The outcome of the events was unknown.
69 2021-04-28 chest discomfort, heart flutter, palpitations it'll feel like little flutters; Heart palpitations; Shortness of breath; Didn't feel like normal se... Read more
it'll feel like little flutters; Heart palpitations; Shortness of breath; Didn't feel like normal self; Site pain; Chest pressure; Difficulty sleeping because of heart rate; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP7534), via an unspecified route of administration administered in right arm on 29Mar2021 at 09:20 (at the age of 69-year-old) at hospital facility as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within four weeks. The patient had no relevant medical history. Patient reported that she has people in the family that have had heart problems. Concomitant medication included unspecified vitamins. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EM9990 or EM9890) administered in the right arm on 08Mar2021 (at the age of 69-year-old) for COVID-19 immunisation and had a little fast heart rate but not constant, little fatigue and site pain. The patient previously took steroid injections 2 years ago (2019) and had heart palpitations before. The patient further mentioned that normally after the steroids wear off, the heart palpitations go away. The patient reported that she did not have any problems following the first dose of the COVID-19 vaccine. Caller reported that she had a little fatigue and site pain for just a couple of days but that everything was fine. Patient reported that she felt a little heart palpitations for maybe a day or two and then it was gone following the first dose of the COVID-19 vaccine. After she got the second dose of the COVID-19 vaccine on 29Mar2021, she noticed the heart palpitations again and a little shortness of breath. The heart palpitations and shortness of breath were nothing that she felt that she had to run to the emergency room or anything over. The patient reported that now it was getting difficult for her to sleep sometimes at night because of the heart rate. The patient also reported that she was trying to figure out that from this length of time between her second dose of the COVID-19 vaccine on 29Mar2021 and time of call on 14Apr2021, could the heart palpitations be a side effect from the COVID-19 vaccine. Patient also mentioned that when she experienced heart palpitations before, a whole work up was ordered and she was referred to cardiology and that nothing was found during the work up after previous experience with heart palpitations. The patient also mentioned that she has been fine, that she has been able to work and walk and that she gets her 10,000 steps every day. After getting the COVID-19 vaccine, she was tired and didn't feel like her normal self. The patient also reported that when the time had arrived to get the second dose of the COVID-19 vaccine, about a week before, she may have had a little fast heart rate but not constant. It was also reported that following her second dose of the COVID-19 vaccine on 29Mar2021, the fatigue started about the same time as it did following the first dose, on the second day post-vaccine on 30Mar2021. Patient reported that she was kind of tired and just taking a nap during the day. The fatigue was still ongoing. It was also reported that patient was starting to feel better other than the heart palpitations. The patient reported that yesterday, 13Apr2021, she felt great and could do her normal routine, other than feeling chest pains and palpitations. The heart palpitations are not constant, but are more regular during the day than she was used to. The heart palpitations were really bad last night, 13Apr2021, and that she had difficulty sleeping because of heart rate (couldn't hardly sleep at all). The patient's doctor was scheduling her for an echocardiogram. The patient's doctor did an electrocardiogram (EKG) on her on 08Apr2021 and there was nothing there (normal). The patient's doctor was scheduling her for a stress echocardiogram. The patient also mentioned that after returning from the physician's office, her husband went back and looked at the symptoms from the COVID-19 vaccine information sheet. The patient reported that her husband thought that she needed to call to eliminate everything, that they are trying to figure out why the patient was experiencing the heart palpitations. The patient also mentioned that 2 days ago she got on her treadmill to walk and went for 30 minutes. Patient reported that it normally takes her 5 minutes to recuperate, but that time it took her 20 minutes before she felt comfortable after her walk. The patient also reported that the site pain was nothing serious following both doses of the COVID-19 vaccine. The site pain began shortly after receiving the vaccine and went away after the second day following both vaccines. The shortness of breath probably started about 5 days after she got the second dose of the COVID-19 vaccine. The shortness of breath wasn't enough that she felt that she needed to run to the emergency room. It just felt like when she would breathe, especially at night as she normally breathes with her mouth closed at night, the patient felt like she had to open her mouth to breathe because she can still feel the pressure in chest. The patient was still experiencing the heart palpitations. The heart palpitations are a little worse because they happen so often. Patient reported that initially, she would have a few heart palpitations and then go for hours with none. Patient reported that now, she was feeling the heart palpitations quite a bit. Patient reported that it feels kind of like a little pressure in her chest and then it'll feel like little flutters. The patient further reported that she experiences a little pressure in her chest when she experiences the heart palpitations. At times, the chest pressure would go away, but she always feels the chest pressure there now. The chest pressure has gotten worse over the past couple of weeks and that she was thinking that it would go away like the first one did. Patient reported that she went to the doctor last week and was given an EKG. Patient reported that the EKG was fine and that her physician was scheduling other tests to make sure it's nothing with her heart. The patient didn't think that the heart palpitations and shortness of breath were from the COVID-19 vaccine, but that her husband looked at the vaccine information paper after her doctor's appointment and said she should call Pfizer. The patient had not yet recovered from heart palpitations, shortness of breath, fatigue, and chest pressure while outcome of the rest of the events was unknown.
69 2021-04-29 cardiac arrest, pulmonary embolism massive Pulmonary embolism causing cardiac arrest
69 2021-04-30 nosebleed Severe inflammation of tendons in right ankle (esp. primary tendon); Nose bleeds; Stuffy nose with l... Read more
Severe inflammation of tendons in right ankle (esp. primary tendon); Nose bleeds; Stuffy nose with little mucus present; Burning in nose; Burning top of mouth; This is a spontaneous report from a contactable healthcare professional (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in the right arm on 08Feb2021 (at the age of 69-years-old) as single dose for COVID-19 immunization. Medical history included multiple seasonal allergies, possible Crohn's disease, gluten sensitivity, allergic or sensitive to all antibiotics and prescription pain killers. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), hydrochlorothiazide, montelukast, and cetirizine hydrochloride (ZYRTEC). The patient previously received BNT162B2 (batch/lot number was not reported), dose 1, administered in the right arm on 12Jan2021 (at the age of 69-years-old) 12:00 PM for COVID-19 immunization. The patient did not have other vaccines in four weeks. In Mar2021, the patient experienced severe inflammation of tendons in right ankle (especially primary tendon identified in MRI), nose bleeds, stuffy nose with little mucus present, burning in nose, and burning top of mouth. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. Treatment included antibiotic for sinus and boot for foot/tendon. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of severe inflammation of tendons, nose bleed, stuffy nose with little mucus, burning in nose and burning top of mouth cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
69 2021-05-01 heart attack Sudden fatal heart attack. Patient went from a medically well person of 69 and died suddenly of PES ... Read more
Sudden fatal heart attack. Patient went from a medically well person of 69 and died suddenly of PES within 2 weeks of dose. Patient reported arm pain, fatigue, and coldness to extremities
69 2021-05-07 fainting, hypertension everything began to swim in front of her/Felt her knees giving out. Woke up face down on floor.; BP ... Read more
everything began to swim in front of her/Felt her knees giving out. Woke up face down on floor.; BP it was quite high; Blood began to drip from head wound.; blood began to drip from head wound; limbs felt rubbery and out of sorts; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 08:30 (Lot Number: ER8732) (at the age of 69-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. The patient not tested positive to COVID-19 pre or post vaccination. The patient medical history was not reported. Concomitant medications included amlodipine; fluoxetine; metoprolol and omeprazole, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient reported that on 24Mar2021 at 9:15 everything began to swim in front of her, the sink, counter, coffee pot, etc. Grabbed edge of sink to steady herself. Felt her knees giving out. Woke up face down on floor. Her limbs felt rubbery and out of sorts. Blood began to drip from head wound. Grabbed counter edge and pulled herself upright. Grabbed paper towel for compress. Wobbled over to sofa. She laid down. Her husband came home measured her blood pressure (BP) it was quite high and would not go down. She went to ER immediately. At ER, they took blood, observed, did Echo on heart and sent her home. No therapeutic measures were taken as a result of the events. The patient outcome of the events was recovered.
69 2021-05-10 heart attack I21.4 - NSTEMI (non-ST elevated myocardial infarction)
69 2021-05-10 cardiac arrest, arrhythmia, very slow heart rate, troponin increased cardiac arrest
69 2021-05-11 deep vein blood clot Patient developed B/L LE DVT 1 week s/p 2nd vaccine; This is a spontaneous report from a contactable... Read more
Patient developed B/L LE DVT 1 week s/p 2nd vaccine; This is a spontaneous report from a contactable physician. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Apr2021 (Batch/Lot number was not reported) as 2nd dose single for covid-19 immunisation. The patient medical history was not reported. Patient was not pregnant. Concomitant medication included estradiol taken for menopausal symptoms, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported. No other vaccines received withing 4 weeks. The patient developed B/L LE DVT 1 week s/p 2nd vaccine on 27Apr2021. Event resulted in physician's clinic visit and was given anticoagulation. Outcome of the events was recovering. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported DVT and the use of BNT162B2 cannot be fully excluded. However, the age of the patient and use of estradiol may confound the reported drug event pair. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
70 2021-01-04 palpitations, atrial fibrillation Patient was light headed after returning to her vehicle post vaccination. Then she started to have ... Read more
Patient was light headed after returning to her vehicle post vaccination. Then she started to have heart palpitations. EMS called an ambulance and put her on a heart monitor. She showed mild Atrial Fibrillation. EMS wanted client to go to the ER but she refused. No other symptoms or treatment that I am aware of.
70 2021-01-05 blood pressure increased, pallor severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash ... Read more
severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash to face and throat,
70 2021-01-10 chest pain Chest pain b/p 176/79 11.25 First at 11:17 am b/p 166/70 11.30, 185/76, 165/74 11.21
70 2021-01-11 hypertension sweating, lightheaded, tingling/numbness in both hands, high blood pressure, swollen arm/redness
70 2021-01-14 blood pressure increased Patient with history of anaphylactic reaction to chemotherapy 9 years ago presents for 1st dose of c... Read more
Patient with history of anaphylactic reaction to chemotherapy 9 years ago presents for 1st dose of covid vaccination. She brought her epi pen with her today. Discussed risks and benefits of vaccine, patient accepts risks and received vaccine. 15 minutes later she developed tingling sensation in throat, denied SOB, wheezing, tongue swelling, stridor, skin rash, chest pain, nausea/vomiting, tachycardia. She was assessed by MD and NP on site. Administered 25 mg of benadryl PO. Vital signs were monitored every 5 minutes for 30 minutes by paramedic on scene. Vital signs were stable throughout assessment. BP slightly elevated during exam. Continued to monitor for another 30 minutes. Patient denies tingling sensation, any SOB, CP, wheezing following 60 minutes total of monitoring. Physical assessment unremarkable. Lungs clear to auscultation, heart rate regular.
70 2021-01-18 chest discomfort Fatigue, chest pressure. Followed up with PCP EKG showed ST elevation; scheduled stress echo next we... Read more
Fatigue, chest pressure. Followed up with PCP EKG showed ST elevation; scheduled stress echo next week.
70 2021-01-18 heart flutter Pt felt alteration in breathing, fluttering in chest (known hx of PVCs) Was evaluated/monitored by E... Read more
Pt felt alteration in breathing, fluttering in chest (known hx of PVCs) Was evaluated/monitored by EMTs at site with return to baseline.
70 2021-01-21 chest discomfort, chest pain One half-hour after injection, I experienced a sudden tight feeling around my chest (rib cage). Pai... Read more
One half-hour after injection, I experienced a sudden tight feeling around my chest (rib cage). Pain was about a 4. I was able to breathe normally at rest. I did not have any other symptoms. Once it came on, the pain may have worsened gradually and then stabilized. After 1.5 hours it subsided and I did not experience any other symptoms since then.
70 2021-01-24 chest discomfort tightening of chest
70 2021-01-25 heart rate increased Heart rate 94 - 112 times two nights; This is a spontaneous report from a contactable nurse (patient... Read more
Heart rate 94 - 112 times two nights; This is a spontaneous report from a contactable nurse (patient). A 70-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 11Jan2021 18:45 at a single dose on left arm for COVID-19 immunization. Medical history included COVID. The patient was not pregnant at the time of vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. No other vaccines in four weeks. The patient received other medications in two weeks prior to COVID vaccine (unspecified). The patient experienced heart rate of 94 - 112 times two nights on 11Jan2021 at 20:00. The patient underwent lab tests and procedures which included nasal swab (COVID test type post vaccination): unknown on 12Jan2021 (reported as result pending). COVID test name post vaccination was PCR. The patient is recovering from the event. Information on the lot/batch number has been requested.
70 2021-01-26 palpitations, lightheadedness Patient received first dose of COVID vaccine. Approximately 10 minutes later patient was experiencin... Read more
Patient received first dose of COVID vaccine. Approximately 10 minutes later patient was experiencing palpitations, dizziness and lightheadedness. Brought patient to exam room to be seen by onsite provider, BP: 130/70 Pulse: 122-140 Oxygen saturation 98% No rash, no hives. Reports no SOB however increased work of breathing. Patient felt increasingly dizzy and felt shaky. Patient had near syncopal episode. EMS was called and patient taken to ER.
70 2021-01-29 loss of consciousness, blood pressure decreased, fainting, heart rate decreased Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone ... Read more
Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone floor and was unconscious. Taken to ER in ambulance. All diagnostics were normal and after blood pressure returned to normal and getting 4 staples in my scalp I was released. Since coming home I have been very ill with weakness, vertigo, nausea, and headache.
70 2021-01-30 atrial fibrillation Went into a sustained A fib event at approximately 8:30 pm approximately 11 hours after receiving va... Read more
Went into a sustained A fib event at approximately 8:30 pm approximately 11 hours after receiving vaccine. Entered ER and was treated for A fib with A fib lasting approximately 10 hours with cardiziem administration and continued to be hospitalized for another 6 hours for monitoring for stability.
70 2021-01-31 chest discomfort Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling ... Read more
Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling well. Pt complained of lightheaded/dizziness, headache, and weakness and transferred to wheelchair. Vital signs monitored (148/77, spo2 100%). Patient stated this is above her baseline and not usual. Patient began to complain of chest pressure and was transferred to EMS stretcher to continue to monitor and transferred to hospital.
70 2021-02-01 platelet count decreased Low platelet number 11000
70 2021-02-02 blood pressure fluctuation PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 12... Read more
PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 122/68, HR 69, RR 16 11:45 BP 121/78, HR 70, RR 16 11:55 PATIENT LEFT SITE IN STABLE CONDITION
70 2021-02-02 atrial fibrillation Very tired with small headache on Jan 30. Monday, Feb 1 awoke to a fib situation. Went to ER and w... Read more
Very tired with small headache on Jan 30. Monday, Feb 1 awoke to a fib situation. Went to ER and was cardioverted back to regular rhythm
70 2021-02-03 hypertension, chest discomfort Had a slight discomfort in the middle of my chest that lasted Friday, Saturday & Sunday.
70 2021-02-03 blood pressure increased, palpitations, pallor, chest discomfort Patient is a 70-year-old female that presents to the ER with complaint of chest pressure and palpita... Read more
Patient is a 70-year-old female that presents to the ER with complaint of chest pressure and palpitations. Patient states this morning she received her second Covid 19 vaccination at 0711. She states about 5-10 minutes after receiving that she started having palpitations, became dizzy and pale. She states staff did check her blood pressure which was elevated. She states her symptoms lasted about 5 minutes and improved. She states at 0726 she started having palpitations again, dizziness and substernal chest pressure/heaviness. She states the dizziness and palpitations have improved but not resolved. pt states she had no reactions with her first dose. Patient denies nausea/vomiting, shortness of breath or recent surgery/travel, fever, cough. Patient states she did take a 81 mg aspirin this morning. 0853- pt resting in the er, nad. vital signs improved. resp equal and non-labored. pt states she feels much better, symptoms resolved. labs / imaging reviewed along with obtaining repeat trop. pt verbalized agreement. 1143- pt resting in the er, nad. vss, pt non-toxic. second trop negative. pt states no further symptoms while in er. denies chest pain, soa, dizziness or palpitations. pt states she feels good to go home. discussed strict return precautions and importance of close f/u with pcp / cardiology. pt verbalized agreement. aware to return to er if concerns or change in symptoms. pt ambulatory out of er with steady gait wo difficulty.
70 2021-02-05 blood pressure increased 2/5/21 2nd Pfizer COVID vaccination ~1050. Began to feel nauseous, headache, increased BP. She had... Read more
2/5/21 2nd Pfizer COVID vaccination ~1050. Began to feel nauseous, headache, increased BP. She had these symptoms with 1st dose also. Was given acetaminophen 500mg po x 1 at 1100. During observation the headache began to resolve. Tends to get nauseated/car sickness and is currently on Prilosec. Placed on pulse oximeter and vital signs monitored. Symptoms are resolving during observation period and a friend is picking her up so she does not need to drive and friend will observe her the rest of the day.
70 2021-02-06 blood glucose increased Fever 103, shakes, chills, profound weakness, loss of appetite, high blood sugar
70 2021-02-06 palpitations, blood pressure increased after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling ... Read more
after 15 minutes feeling hot, heart beating hard in chest, after 30 minutes dizzyness, lips feeling numb and tingly, was taken to ER as it was part of the same building in a wheel chair, was also anxious, nauseated and had dry heaves and blood pressure was elevated. Received IV solumedrol, ativan and zofran and then later oral benadryl. I was told to contact my PCP to see if I should get the second vaccine and he indicated no.
70 2021-02-07 cerebrovascular accident Left MCA stroke, is currently in the CCU
70 2021-02-07 hypertension due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but s... Read more
due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but she tested positive for COVID yesterday; Dizzy; starting to get foggy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899 or EH9897), via an unspecified route of administration at the left arm on 04Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing diabetic, blood pressure high, high cholesterol and sore arms from previous vaccines (unspecified).She had energy for a whole week after getting the vaccine, that she has not had for a long time, she even cleaned out her whole garage; has been waiting to do that for 3 years; had to make herself stop to rest. There were no concomitant medications. The patient got her first dose on 04Jan2021 and was due to get the 2nd dose this coming 25Jan2021, but she tested positive for COVID on 21Jan2021. She has been sick for a week which started with an irritating cough on 14Jan2021. She went to the ER because she was dizzy as could be on Jan2021. She does not remember which day; she was starting to get foggy on Jan2021. She was not admitted. She did a drive through rapid test on 21Jan2021 and it was positive. Lot numbers: Handwriting on her card was bad and she cannot tell if the last digit of the Lot number is a 9 or 7. The vaccine was administered in an open tent clinic outside in a parking lot outside a hospital and not in a military facility. The outcome of the event was unknown. Information on Lot/Batch has been requested.
70 2021-02-07 nosebleed sore throat; discharge/drainage from nose; really tired; couldn't stay awake 4 hours after, she went... Read more
sore throat; discharge/drainage from nose; really tired; couldn't stay awake 4 hours after, she went to bed and slept for 12 hours; muscle aches; nose was crusty; discharge from her nose, bloody/it was a little bloody; inflammation; cold; Cough; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 15Jan2021 at single dose for covid-19 immunization. There were no concomitant medications and medical history. She had still has a sore throat, it has been a week since her first injection, and she immediately like got a sore throat straightaway, then drainage, and she was really tired and had to go to bed in about 4 hours. She couldn't stay awake 4 hours after, she went to bed and slept for 12 hours after the first shot. There was discharge from her nose, bloody, crusty like a cold, and she seldom ever has a cold and that continued, she didn't feel good until about maybe 4 or 5 days later. Sore throat was immediately after she thinks, it was certainly the next day (16Jan2021), and her date of vaccine was 15Jan2021. Now states and cough developed not until later. On 15Jan2021, she had the shot, she was really tired, muscle aches, the kind of things on the sheet, if not that evening, but the next day (16Jan2021), then drainage, it was white at first, it didn't turn yellow until a few days later, had a yellowish tinge, so she is sure there was inflammation, and her nose was crusty, in the morning it was a little bloody, and she had a sore throat, and probably by the Wednesday or Thursday, so 20 or 21Jan2021, there was a little cough, in the evening, and she is not experiencing that today. The outcome of the event sore throat was not recovered, cough was recovered on 22Jan2021, cold was recovering, other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
70 2021-02-08 blood pressure increased Client verbalized feeling dizzy after receiving the vaccine. She was evaluated by onsite nurse prac... Read more
Client verbalized feeling dizzy after receiving the vaccine. She was evaluated by onsite nurse practitioner. Client was advised to seek additional evaluation. Client declined to be transported to the hospital for elevated blood pressure. Client was released out at 3:51 pm accompanied by co-worker.
70 2021-02-08 chest discomfort Headache, Fatigue, Tingling & Numbness, Tightness in upper chest 11:20am-4pm
70 2021-02-09 chest pain, atrial fibrillation Chest and body aches, new onset afib with RVR upon admission
70 2021-02-09 fast heart rate Client reports tachycardia of 120-130 bpm from 1800 on 2/4/21 until 0700 on 2/5/21, when bpm decreas... Read more
Client reports tachycardia of 120-130 bpm from 1800 on 2/4/21 until 0700 on 2/5/21, when bpm decreased to about 100. She returned to baseline, 80 bpm, by 9am. No other symptoms.
70 2021-02-09 cardiac arrest My mother died suddenly on February 3rd. She went into shock/cardiac arrest and appeared to have int... Read more
My mother died suddenly on February 3rd. She went into shock/cardiac arrest and appeared to have internal bleeding. No autopsy has been performed. Unsure if it was related to the COVID vaccine.
70 2021-02-09 loss of consciousness Pt had a Covid shot on 02-08-2021.She went home and the next Morning she got out of bed and ended ... Read more
Pt had a Covid shot on 02-08-2021.She went home and the next Morning she got out of bed and ended up passing out and hitting hev head on a coat rack. she came into the Dr on 02-09-2021. She has a Left frontal 1cm Laceration, abrasion at right scalp, bridge of Nose with a shallow 4mm laceration . Black eyeon the right side
70 2021-02-14 fast heart rate Explosive Diarrhea, & explosive vomiting lasting over 10 hours. Rapid heart rate which began prior t... Read more
Explosive Diarrhea, & explosive vomiting lasting over 10 hours. Rapid heart rate which began prior to above diarrhea & vomiting. Muscle cramping & muscle twitching much like electrical shock especially in lower extremities along with severe headache. Low grade fever & mild chills. Extreme tiredness/low energy which still remains. There was also a degree of dizziness which remains as well.
70 2021-02-14 hypertension Patient feeling sweaty and weak.. History of DM and HTN. Did not take meds this morning. BP- 195/92... Read more
Patient feeling sweaty and weak.. History of DM and HTN. Did not take meds this morning. BP- 195/92, after 2 minutes 199/101, after 5 minutes- 179/101 Monitored and released to home after 30 minutes. Will take BP meds when gets home and follow up with primary MD
70 2021-02-15 palpitations 1318; patient c/o palpitations& SOA. Trembling to B UE. pt showing "EKG" result from apple watch t... Read more
1318; patient c/o palpitations& SOA. Trembling to B UE. pt showing "EKG" result from apple watch that she describes as "afib". Denies need to be seen in ED PB 197/102, HR 62, SpO2 98%; 1325; BP 174/85, HR 65, SpO2 98%; 1334; BP 138/84, HR 65, SpO2 98%
70 2021-02-15 deep vein blood clot Pt initially had diffuse joint pain, then worsening pain and swelling in RLE. Had DVT u/s + for DV... Read more
Pt initially had diffuse joint pain, then worsening pain and swelling in RLE. Had DVT u/s + for DVT No history of blood clots, no prior risk factors Cannot be certain that she did not have clot prior to vaccine, although she never had pain or swelling to this degree (1-2 mo prior thought skinny jeans were slightly tighter on R than L, but no visible swelling. Now with RLE 2x size LLE)
70 2021-02-16 heart rate increased 01/27/2021 at 1514 Particpant c/o of fast heart beat, possible difficulty breathing and hand tinglin... Read more
01/27/2021 at 1514 Particpant c/o of fast heart beat, possible difficulty breathing and hand tingling. Assessed & noted p - 109, O2 sat 97%, skin warm / clammy with no discoloration at left upper arm injection site. Allergies verified and noted as Sulfur, Levaquin and PCN. Participant remained sitting and encouraged to deep breathe. At 1518 B/P 153/100, HR 102, O2 sat 98% with continued c/o. EMS activated at 1518 and pt moved to monitoring area; declined lying down, sat in chair for care. Post move to chair O2 sat drop to 90% then returned to 96%, HR 111. 1522 Administered Benadryl 50 mg IM right upper arm with no resp distress / rash noted. At 1554 participant voiced feeling better already with arrival of EMS noted
70 2021-02-16 platelet count decreased Low platelets; Rash on her body; Bruising; This is a spontaneous report from a contactable consumer.... Read more
Low platelets; Rash on her body; Bruising; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3249), via an unspecified route of administration in the right arm on 19Jan2021 at a single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus since 2011 (reported diagnosed 10 years from this report, ongoing congenital heart defect which patient was born with but did not find out until she was in her 50s; does not bother her too much; one of the major arteries has a 90 degree angle vs. an S curve, mild multiple sclerosis; no longer has this as she has not had another relapse; she was diagnosed almost 30 years ago; she has never had another attack since she had 2 of them and was on medication that did damage to her liver, breast cancer; patient is a breast cancer survivor and issues with magnesium levels. There were no concomitant medications. On 28Jan2021 the patient had blood work done for her kidney doctor. They withdrew blood from her arm. They had a hard time stopping the bleeding afterwards. They finally got it to stop and put regular cotton balls and a band aid on it. By the time she was walking out she was bleeding out of her arm she felt in her coat. They were able to stop the bleeding again. This was at about 10 AM. Patient went home and afterwards was called back and instructed to go to the ER for critical care. Her platelets were low at 10,000 at that time. They got to the ER and they checked her platelets and they were down to 8,000. They administered some steroids; Prednisone. They decided to admit her after giving the treatment in the ER. After that her platelets came back to 11,000. The next morning on 29Jan2021 her platelet count was 7,000. They started administering the same drug through an IV. He thinks it was still a steroid. They did it in smaller amounts and overnight the next day her platelets were up to 26,000 on 30Jan2021. They continued the treatment during the night again and on Sunday they were 36,000 and they released her that day late on Sunday. They went back and did blood work yesterday on 01Feb2021. The local doctor said her platelets are up to 61,000. The patient was getting blood work every Monday and Thursday for 3 weeks. Th patient had blood work and platelets checked before the vaccine and they were normal. The patient was hospitalized from 28Jan2021 to 31Jan2021 due to the event. The patient also noticed rash on her body and bruising maybe on 21Jan2021 or 22Jan2021. The bruising was really bad on her left hand by her wrist. It was really dark. She was also bruised everywhere they poked her with an IV and bruises where they put the heart monitor on her and pressed down to stick it to her. The bruising is still all over her body. It has stayed about the same. The one on her hand is still severe. The other from where she has been poked are starting to clear up. Overall it was about the same. The outcome of event bruising was not recovered, low platelets was unknown while rash on her body recovered on unspecified date.
70 2021-02-17 hypertension shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this wa... Read more
shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this was the 4th time; kidney infection; hurting on my waist around the back; diverticulitis; Her blood pressure went up to 211/92; does not feel well; afraid of taking it if it will be any worse; sick; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot: EL3248, expiry 30Apr2021), intramuscular on 23Jan2021 08:15 at a single dose in the left arm for COVID-19 immunization (prevention because she has autoimmune). Medical history included Behcet's syndrome and Sjogren's syndrome, both are overactive immune system problem/autoimmune diseases, which were diagnosed 20 years ago; diagnosed allergies; compromised immune status; respiratory illness; genetic chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; and patient have had shingles before. Family history was reported as none. Concomitantly, she was just taking daily medications that were not relevant. There was no prescriber for the vaccine. It was through a hospital. It was reported that vaccination was given at 08:15 to 08:30. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered the same date of the Pfizer suspect. Patient had not had prior vaccinations (within 4 weeks). Patient received her first dose of the Pfizer vaccine on Saturday 23Jan2021. She stated, on Tuesday 26Jan2021, patient was hurting on the waist around the back. On Wednesday, 27Jan2021, that next morning, she went to see her internal doctor and they thought a kidney infection or not; he was not sure if she had a kidney infection or what was going on. Patient went home and it got worse and patient went to the ER (Jan2021), also reported as ended up going to the ER. They did a CT scan gave her medicine. They did a CT scan and said it was not her bladder or anything (Jan2021). They thought it was diverticulitis; nothing helped. They gave her medication and she kept getting sick (2021). No further details provided on medication given. On Friday, 29Jan2021, early morning, patient went back to the ER, they did another CT with contrast it wasn't diverticulitis, but it was shingles, and patient have had shingles before, this was the 4th time. It was reported that when the doctor came in, he thought this was shingles and she has had shingles previously. She has had it about 3 other times and the pain was just off the scale (Jan2021). Her blood pressure went up to 211/92 and they were giving her morphine for the pain (Jan2021). She was questioning if she should get the second dose. She has two autoimmune diseases and it was an overactive immune disease. She took the one vaccine and her doctor said to contact Pfizer being as it is kind of new and especially since she has the autoimmune issues. She would like to know if it is safe for her to have the second vaccine. She does not know if she will be over this. She does not feel well (Jan2021). She was afraid of taking it if it will be any worse (Jan2021). Patient felt all right until she had the vaccine, on Tuesday the problem started (26Jan2021). They were giving her medication for the shingles and for the pain. Patient stated that "it set something off". Patient was still sick (2021), still taking pain pills. Patient didn't know how many days she has. Her second vaccine is on 13Feb2021. As sick as she has been, and her overactive immune system and if she still has the shingles those can last a long time, she doesn't want to go through what she went through. This was a lot of pain and with shingles they can last, 6 months or a year. The nurse called her back and told her to report to Pfizer. Patient was taking the medicine for the shingles right now. She doesn't know what will happen. She doesn't want to be sick. Patient asked for the efficacy after 1 dose and how much protection it has. She did fill out something because she talked with someone else. She confirmed it was through VAERS and not with Pfizer. She said the pain around her waist was a little better because they gave her the medicine for shingles and she has pain pills. She said one was Valacyclovir and she could not remember the name of the other. Patient had required two trips to ER. First one was on 27Jan2021 and went to internal medicine doctor and that night went to the ER. They did CT scan and it was not bladder or anything. Second visit on 29Jan2021 and did CT with contrast and the doctor thought it was shingles since she had shingles three times before. She has had them internally. The doctor said it would not necessarily need to be externally break outs. The next two times she did not break out. She did not have anything around her waist. Therapeutic measures were taken as a result of the events hurting on my waist around the back, kidney infection, diverticulitis, shingles, and sick. The outcome of the event hurting on my waist around the back was recovering. The outcome of the event kidney infection, diverticulitis, shingles, sick, blood pressure went up to 211/92, does not feel well, and "afraid of taking it if it will be any worse" was unknown.
70 2021-02-18 blood pressure increased 10 minutes after receiving her first dose of Covid vaccine, patient felt dry, itchy throat and had a... Read more
10 minutes after receiving her first dose of Covid vaccine, patient felt dry, itchy throat and had a dry cough. She was brought to us by EMS staff for medical evaluation. BP was elevated. Denies any other symptoms. Face slightly flushed, chest CTA, RRR, able to communicate well, A&O. BP 184/115 left arm, repeat after 10 minutes: 164/102. has hypertension and took her med today. Symptoms resolving and after approx 20 minutes, completely resolved. Patient declines to be transferred to local healthcare facility and agreed to call her PCP once she returned home to notify of BP and possible reaction to vaccine. Feeling much better, she stated her husband was here and she was going home.
70 2021-02-18 fainting Chills, joint pain, body aches, syncopal episode, diarrhea, headache, malaise
70 2021-02-18 blood pressure increased, palpitations Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in... Read more
Feeling very hot; lips numb and tingly; lips numb and tingly; headache; dizzy; heart beating hard in chest; anxiety; nausea with dry heaves; nausea with dry heaves; elevated blood pressure; This is a spontaneous report from a contactable nurse (self-reported). A 70-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; el3249) via an unspecified route of administration, at right arm on 14Jan2021 14:00, at hospital for COVID-19 Immunization. Medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), oral cancer 2020 with surgery only, arthritis, hypothryroid and allergies to nickel. Concomitant medications included, irbesartan (AVAPRO), levothyroxine, liothyronine (NP THYROID), lansoprazole (PREVACID), ibuprofen (MOTRIN) and paracetamol (TYLENOL). The patient previously took metoclopramide (REGLAN) and prochlorperazine edisylate (COMPAZINE); patient had allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of medications the patient received within 2 weeks of vaccination, included: avapro, np thyroid, prevacid, motrin, Tylenol. On 14Jan2021 at 14:15 (after 15 minutes of dose), the patient experienced feeling very hot, lips numb and tingly, headache, dizzy, heart beating hard in chest, anxiety, waited another 15 minutes, taken to ER (Emergency Room) on site; elevated blood pressure, nausea with dry heaves. Patient was taken into Emergency room/department for urgent care and received treatment IV solumedrol, ativan and zofran, oral Benadryl. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unknown date in 2021; Sender's Comments: There is a reasonable possibility that the events headache and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported serious events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
70 2021-02-18 heart rate increased I felt fine for the first 5 minutes after my Pfizer shot (my first shot), but then started to have r... Read more
I felt fine for the first 5 minutes after my Pfizer shot (my first shot), but then started to have rapid heartbeat, anxiety and felt warm. The nurse checked my breathing and checked for rashes and said it was not an anaphylactic reaction. Symptoms subsided after 5 or so minutes and I went home and have not had further side effects. But my question is, should I get my second shot in 3 weeks?
70 2021-02-18 heart rate increased, blood pressure decreased One week after injection, in the evening, my blood pressure dropped to 59/35 and my heart rate jumpe... Read more
One week after injection, in the evening, my blood pressure dropped to 59/35 and my heart rate jumped to 90.
70 2021-02-18 atrial fibrillation went into afib that required hospitalization X24 hours after receiving immunization.; This is a spon... Read more
went into afib that required hospitalization X24 hours after receiving immunization.; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265; expiry date: unknown) intramuscular in the right arm, on 29Jan2021 at 09:30, at a single dose, for immunization/COVID-19 immunisation. Medical history included atrial fibrillation (afib). It was unknown if the patient has allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient stated that she has a history of afib that has been well controlled for over 2 years. Patient has had 0 episodes during the past 2 years, but on 30Jan2021 at 14:00, she went into afib that required hospitalization X24 hours after receiving immunization. Patient also stated that afib is usually able to be converted with cardiazem but it was not effective this time. Outcome of the event was recovered. It was unknown if the patient was tested for COVID after vaccination.; Sender's Comments: A causal relationship between the event "went into afib that required hospitalization X24 hours after receiving immunization" and suspect product bnt162b2 is possible based on the information provided, drug profile and a temporal association in this 70-year-old female patient with history of Atrial fibrillation. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
70 2021-02-21 chest discomfort, chest pain 27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature wen... Read more
27 hours after injection I began to feel a migraine, chills, incredibly tired and my temperature went up to 100.8. My chest was tight and achy and my oxygen levels stayed at about 88. I slept about 10 hours and woke up feeling fine. My chest is sore and achy but better than yesterday.
70 2021-02-21 chest pain 5min after vaccine as per daughter, her mother began complaining of "burning " in her chest , itchi... Read more
5min after vaccine as per daughter, her mother began complaining of "burning " in her chest , itching in her throat, lump in her throat, hives/redness noted on throat and chest. RRT responded and accompanied patient to ED
70 2021-02-21 loss of consciousness, blood pressure decreased, lightheadedness Approx. 1 hr. & 20 min. post injection, severe reaction: Severe upper abdominal pains, multiple, unc... Read more
Approx. 1 hr. & 20 min. post injection, severe reaction: Severe upper abdominal pains, multiple, uncontrollable formed to diarrheal bm's triggered vagal response, passed out, severe diaphoresis, violent chilling loss of control of bowel movements. Lasted approx. 30-35 minutes. crawled with head hanging to floor to keep from passing out, to locate a phone for help. after several of agonizing attempts to try and climb up to couch to elevate legs high above head and laying there for approx. 20 or more min. blood pressure came up some. (Did not call emergency services) afraid of hospitalization due to all chronic health problems, (forgot to report earlier that I am Hypothyroid as well) previously hospitalized for a Thyroid Storm. This is day 10 from injection and still have nausea, dizziness & fatigue, (also have couple episodes of abdominal pain). (I want to add that I felt completely fine prior to receiving 2nd Pfizer Covid dose). I am contacting my doctor today to receive some IV fluids.
70 2021-02-21 fast heart rate, palpitations Tachycardia and palpitations. Currently on holter monitor for SVT. Followed up with PCP and did rece... Read more
Tachycardia and palpitations. Currently on holter monitor for SVT. Followed up with PCP and did receive 2nd dose without issue.
70 2021-02-22 chest pain 2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, ve... Read more
2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, very tired/fatigue, moderate to severe upper body muscle aches, mild migratory chest pains for about 30 minutes. 24 hrs after injection just overwhelming fatigue& mild headache continued for another 12 hrs. 48 hrs. After injection symptoms gone.
70 2021-02-22 blood glucose increased, heart rate increased 2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-g... Read more
2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.
70 2021-02-22 chest pain I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. ... Read more
I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. There was a sense of nausea initially but it went away. There was pronounced feeling of heat located subcutaneously on my right outer thigh. It came and went about every minute or so. (I counted the seconds in between each incident). I am still experiencing flu like symptoms (bodily aches, slight headache, mild chest pain, and general ill-feeling.) I will contact my primary care physician today about my concerns but felt it necessary to document these mild but disturbing side effects.
70 2021-02-23 chest discomfort, palpitations 3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visio... Read more
3rd day after vaccine: fatigued, headache, unable to concentrate 4th day: disoriented, strange visions when eyes were closed, fatigue, VERY loud ringing in ears, tight chest, puffy eyes, heart racing & pounding 5th day:Diarrhea, fatigue
70 2021-02-23 chest discomfort arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then al... Read more
arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then also and found swelling like an orange, swelling lasted 8 days but was decreasing in size. became very cold and went into violent shaking tremors - 4-6 of those as i lost count. these violent tremors were from 10:30 pm on monday through 1:45 am tuesday. i had one other tremor on day 4. fever for 4 days and spiked on 5th day ranging from 101.8 - 100.3, severe all over body aching especially right armpit, lower back especially right side and across shoulders, aching lasted 8/9 days and lessened after 5 days. pressure on chest which ranged from very heavy to mild and in some form lasted 10 days, hurt to breath but i could breath. woke up on night 7 with heavy, painful chest pressure on left side but it subsided in 6-8 hours. nasty headache began day 2 and lasted several days; nothing relieved it. headache for 4/5 days and then off and on for a few days. i am not prone to headaches. coughing which lasted several days. on third day post vaccine had violent nausea one time. became weak and lightheaded. no energy and stayed in bed 5 days. on day six i started getting out of bed for several hours multiple times/day. weak and very low energy. exhausted easily. i had some of these symptoms for 10 days. the first 5 days were terrible and i was very ill.
70 2021-02-23 pallor, chest discomfort, heart attack nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to... Read more
nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
70 2021-02-24 fainting Dizziness; faint; feeling of falling off my chair; vision went black.
70 2021-02-24 lightheadedness Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vacci... Read more
Patient was alert and conversational throughout first COVID-19 Pfizer vaccination. During post vaccination waiting period, patient became unresponsive and exhibited convulsion like movements in her waiting chair. Pharmacist quickly evaluated patient and patient was only minimally responsive to painful stimuli only. Breathing was rapid, shallow, and irregular with an expiratory wheeze heard upon auscultation. Patient was slouched in chair but supporting self and had a strong grip with her left hand. Skin condition was warm but diaphoretic. Ambulance 911 service was called. No swelling of the throat, mouth, face, nor lips was seen. Patient continued to be non-responsive, with non-comprehensible sounds, and was not opening eyes or following commands. Due to worsening ability to breath and wheezing on expiration, epinephrine 0.3 mg was administered intramuscularly into the left thigh at 1230 on 2/25/2021. Approximately 5 minutes after epinephrine administration, the patient?s work of breathing improved, wheezing was diminished upon expiration, and respiratory rate had slowed to 16 breaths per minutes. BP was 160s/80s and HR 98 (after epinephrine administration). Patient began opening eyes spontaneously but was still not following commands. Ambulance service then arrived, report was given, and patient was transported to Hospital Emergency Department. Patient was under the care of Doctor at the emergency department and received albuterol/ipratropium nebulization, dexamethasone 10 mg Iv, famotidine 20 mg IV, and magnesium sulfate 2 g IV. After the physician evaluated the patient and talked with family, the patient?s family stated that the patient has a history of anxiety related reactions such as this with convulsion like activity. Doctor then determined that the patient did not have an anaphylactic/allergic reaction and instead had a anxiety related vasovagal type reaction. Doctor stated that the patient could receive the second COVID-19 vaccine dose in 3 weeks without issue. Patient then discharged from Emergency Department (unsure if AMA). Patient then presented to the pharmacy with her daughter after discharge to fill in staff on the outcome of the reaction. Patient appeared to be at baseline mentally and physically. Pharmacist contacted Emergency Department to discuss case with patient?s nurse to obtain information about medications received in the emergency department. Patient daughter stated that she would like to be present for second dose of vaccine to help avoid a similar anxiety related reaction from occurring.
70 2021-02-24 chest discomfort Progress Notes Family Medicine 2/25/2021 ... Read more
Progress Notes Family Medicine 2/25/2021 Date: 2/25/2021 Subjective Is a 70 y.o. female who was seen at a vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience nausea, belching, sob. She denied rash, hives, welts, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms, respiratory distress and vomiting. PMH: pt reports recently admitted for unstable angina and CAD with tachycardia. Had elevated d-dimer and blood clot was ruled out. Pt dc'd on new medication, beta blocker. Since discharge this Sunday, she reports chest heaviness as if she has "cardboard on my chest." Can slightly increase with going up and down stairs or increased activity. She states she had reached out to her cardiologist via my chart but has not heard back. States her pain is about the same today. Upon 15 minutes after injection, she noted nausea with belching and had some sob. Symptoms worsened as she ambulated over to the medical bay along with her chest pressure. ALLERGY REVIEW OF SYSTEMS: Patient complains of chest tightness and shortness of breath Patient denies chills, malaise/fatigue, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, wheezing, rash, hives, eczema, itching of skin, abdominal pain, muscle aches, dizziness and headaches + nausea and belching: Previous Reactions: none Objective Vitals Vitals: 02/25/21 1000 02/25/21 1008 02/25/21 1013 BP: (!) 157/102 (!) 144/86 (!) 169/94 Pulse: 72 SpO2: 97% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: She has nitro on hand. We gave that at 10:03 am. Follow up response to treatment: fair. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Firefighters responded first at 1008 Arrived at 1011. EKG done, no acute findings. Pt reports pain at 0 after nitro administration. Belching and nausea reduced. Pt taken to ED for further evaluation. ED called and given report at 1020 Electronically Signed 2/25/2021 10:24 AM
70 2021-02-24 heart rate increased Rapid heartbeat, lightheaded, sweating, about 5 min duration. Then again 23 hours after vaccination.
70 2021-02-24 hypertension Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face beco... Read more
Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face becoming hot, her cheeks being red, and a headache. EMS evaluated patient on-site. Patient was hypertensive (206/96). EMS transported patient to Emergency Department for further evaluation. In ED, patient was still hypertensive, but in no acute distress. Per patient, she was taken off losartan by PCP in September secondary to hyperkalemia. ED physician administered losartan and Tylenol. Patient was discharged with HTN, HA, and vaccine reaction.
70 2021-02-24 chest pain, fainting, heart attack did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; ... Read more
did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; chest was killing me and hurting and I was sobbing and it lasted about an hour and 15 minutes; Side of my neck hurt; My back hurt; It was just awful; Lethargic; I ended up vomiting for 2 days after the chest pain receded; slept for 16 hours; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients (husband and wife). This case refers to the wife with serious adverse events. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration was not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux. Concomitant medication included dexlansoprazole (DEXILANT) for acid reflux. Patient reported that she had terrible severe reaction on the 22Jan2021. They were vaccinated on the 18Jan2021 and on the night of the 22Jan2021, she had such crushing chest pain that she just collapsed. Her chest was killing her and hurting and she was sobbing and it lasted about an hour and 15 minutes. The side of her neck hurt and her back hurt. It was just awful. Patient reported that she have called everybody. She have called her doctor's assistant and she confused her. Patient reported that they just went in because they were 70 and 71 and got the vaccine but then she ended up vomiting for 2 days after the chest pain receded and they took baby aspirin and then she just vomited and vomited and slept for 16 hours. They were both very lethargic. She asked her what should she do. She does not know if this was a reaction to the vaccine or did she have a heart attack. No doctor will see her to give me an EKG. They say they are not seeing patients. The patient recovered from chest pain on an unspecified date; while outcome of the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115775 same reporter/drug, similar event, different patient.
70 2021-02-25 fainting Approximately 4 minutes post vaccine pt fainted in chair during obs. Pt transferred to gurney, RRT c... Read more
Approximately 4 minutes post vaccine pt fainted in chair during obs. Pt transferred to gurney, RRT called at 0840, they arrived 0846. Denies high BP. Vitals taken (0843)198/95, HR 96 o2 97% T-98.6. Pt comes to and reports hx of fainting with needles and nausea. No medical hx. Currently feels better and refuse to go to ER x3. V/s(0846) 195/95 HR 81 o2 97%. Husband by bedside fans pt. Continues to refuse ED service. (0855) 124/60 HR 81 o2 97% RRT left at 0852. Pt became anxious 0942 BP 173/81 HR 83 o2 97% pt wants to be released home AAO. D/C @ 0945 with husband.
70 2021-02-25 heart rate increased Rapid heartbeat Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of ... Read more
Rapid heartbeat Numbness in my neck and face Numbness in my lips, swelling in lips Numbness tip of tongue Chills, weakness, headache, blurred vision for a short time Took Benadryl on my own, continued taking non drowsy Claritin 5 days after shot feeling better. Still have slight numbness in my lips and feeling weak
70 2021-02-25 hypertension, atrial fibrillation She has high blood pressure; she developed Afib; This is a spontaneous report from a contactable con... Read more
She has high blood pressure; she developed Afib; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received bnt162b2 (BNT162B2; Lot # EN5318) vaccine, via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient developed atrial fibrillation on 29Jan2021 with outcome of unknown , she has high blood pressure on an unspecified date with outcome of unknown. The patient laid down and she could feel her heart beating real fast. She has high blood pressure so she went to taking her blood pressure and her heart rate was like 100. On Sunday night of that week it got worse and her blood pressure got higher so she called 911 and they took to the ER. She says this was her first ever episode with Afib she never had it before this. The patient was treated with metoprolol and rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood pressure measurement: high and heart rate: heart rate was like 100. Both the reported events were considered serious because Important Medical Events. Follow up information has been requested.
70 2021-02-25 blood pressure increased, fainting fainted twice while visiting the bathroom; BP was 145/85; arm was sore; This is a spontaneous report... Read more
fainted twice while visiting the bathroom; BP was 145/85; arm was sore; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot_number m000007217771.CSN20 447277212), via an unspecified route of administration in left arm on 11Feb2021 16:45 at single dose for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included hypertension, blood cholesterol increased, anxiety, allergies, allergies to penicillin, Sulfa drugs and Crustacea. The patient previously took tetracycline and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Concomitant medication included olmesartan medoxomil (unknown manufacturer), diltiazem hydrochloride (unknown manufacturer) and sertraline hydrochloride (SERT). On 12Feb2021 her arm was sore but she was not really feeling anything more. On 13Feb2021 morning at 04:45 the patient fainted twice while visiting the bathroom. Upon checking of the BP it was 121/75. Later in the day the BP was 145/85. The patient was completely normal before the shot. It seems that the vaccine affected my BP. The outcome of the events was recovered in Feb2021. No treatment was performed. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
70 2021-02-25 loss of consciousness slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous repo... Read more
slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 10Feb2021 at 16:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included type 2 diabetes mellitus, hypertension and allergy to Victoza. Concomitant medications included metformin, dulaglutide (TRULICITY), atorvastatin and fluoxetine. On 10Feb2021 at 21:00 about the patient five hours after vaccine in kitchen washing dishes, passed out. No symptoms or light headedness leading up to this event. Patient woke up on floor hit head minor and knees. On 11Feb2021 the patient complained slight soreness on head, fuzzy feeling. Knees extremely sore, small cut on ankle. Her doctor adviced to report this due to the time event happened in relation to vaccine (as reported). No treatment reported for events. At the time of the reporting the patient was recovering from the events. .
70 2021-02-27 blood glucose increased within 1 hour started throwing up, continued for the next 12 hrs. Blood Sugar went to 700 and would ... Read more
within 1 hour started throwing up, continued for the next 12 hrs. Blood Sugar went to 700 and would not come down with long term and short term insulin. called 911, taken to Hospital ER. on feb. 27 @ 8:00 am Admitted and still is in ICU today 2-28-2021.
70 2021-02-28 chest pain Dentist used lidocaine 2% with epi injection to numb so she can do a deep cleaning. Pt was very nerv... Read more
Dentist used lidocaine 2% with epi injection to numb so she can do a deep cleaning. Pt was very nervous. She was fine when getting injection but 15 min later when SRP almost done, pt complained that she had the chest pain. The procedure had been terminated right away at 9:46am and the code blue had been activated. I stayed with the pt the whole time in the room to make sure she was fine untilThe Medical staffs came and took over right after the code blue, about 2min. Pt had been checked and took care by medical staffs and she was transferred to MD side for EKG. HX: she has the pacemaker and had covid vaccine 3 days ago.
70 2021-03-01 loss of consciousness Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out ... Read more
Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out of sorts; feeling light headed; This is a spontaneous report from a contactable consumer (patient) who reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number:EL3246), via an unspecified route of administration into the right arm on 10Feb2021 07:45 at a single dose for COVID-19 immunisation. Medical history included known allergies to CT dye, COVID-19 from an unknown date prior to vaccination and known allergies to sulfa drugs. Patient was not pregnant. Patient had unspecified concomitant medications. On 11Feb2021 08:00, patient woke up feeling out of sorts and feeling light headed, patient sat down and the next thing she knew she was on the floor bleeding from a small gash in her head, she lost consciousness for a brief period and also broke her finger. The events required emergency room and physician office visit. The patient had 3 staples in her head and a finger splint for the events "bleeding from a small gash in her head" and "broke her finger". Outcome of events was recovering.
70 2021-03-01 blood pressure increased Pt felt lightheaded and dizzy. Pt was brought into medical room. Laid onto stretcher and vs were tak... Read more
Pt felt lightheaded and dizzy. Pt was brought into medical room. Laid onto stretcher and vs were taken . Bp was 142/103 and pt was allowed to rest for 15 mins. Pt symptoms kept persisting and bp went up. Pt spent an hour with no relief of symptoms. Pt wanted to get checked out at Hosp. 911 was called and pt wax placed on heart monitor at hospital. Iv ns was given kvo at 500ml via 22g cath in lt wrist. Pt was t/f to 911 stretcher and pt care was t/f to 911 wo incident .
70 2021-03-02 blood pressure increased Pt c/o burning in nose area and pt reports pain, itching & burning down her left arm, which then rad... Read more
Pt c/o burning in nose area and pt reports pain, itching & burning down her left arm, which then radiated across her shoulders. Pt has wheezing which she reports is normal for her. BP is elevated, pt reporting not taking her meds this a.m. MD ordered breathing treatment of albuterol and metoprolol 50mg po for BP of 175/101. HR 68 SR 100%SpO2/RA,RR=21, No Respiratory Distress Noted
70 2021-03-02 hypertension Pt reported extremely cold feet app 10 minutes after vaccine administration. Vital signs were taken,... Read more
Pt reported extremely cold feet app 10 minutes after vaccine administration. Vital signs were taken, initial BP 186/87, P 65, PO2 100%. Pt said BP was extremely high for her. F/U BP = 194/84. Pt was subsequently assessed by MD, who knew pt as a PCP. Reported elevated BPs for pt in past, but not that high. Next BP 202/97. Pt then went to the bathroom, took a walk outside. Came back, manual BP 160/89, coldness in feet resolved. Pt was started on amlodipine 2.5 mg PO daily, to f/u with PCP in 2 weeks.
70 2021-03-02 chest pain fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no uri... Read more
fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no urine output for 24 hrs, vertigo, fatigue, severe stabbing pains in face and head, stiff neck, no appetite, difficulty swallowing, pain in joints, chest pain, pain across upper back, stomach pain,. Symptoms lasted for 3 to 4 days. Severe head pain lasted 4 days. Could not raise left arm for 24 hrs after injection. After 6 days fatigue and general malaise still present. Stomach pain still comes and goes.
70 2021-03-03 palpitations I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose, I de... Read more
I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose, I developed mild fever (under 100)*F, a bad headache, blurred vision, nausea, joint pain and fatigue. I took Tylenol for the fever and headache and recovered after 2 days. However, on 2/28/21 I developed a SECOND SERIES OF SIDE EFFECTS starting 8 days after the 2nd dose. I developed a fever of 100.7*F , a bad headache, nausea, palpitations, and severe joint pains and strong fatigue. I consulted my PCP, who recommended I fill out this report. I took Advil on 2/28, improved after 2 days, and now have a slight headache and some fatigue but otherwise recovered.
70 2021-03-03 fainting, lightheadedness Patient was admitted due to having a syncopal or near syncopal episode while dry heaving. She was fo... Read more
Patient was admitted due to having a syncopal or near syncopal episode while dry heaving. She was found to have a probable gastric outlet obstruction and an NG tube was placed initially. She is being followed by general surgery and GI, underwent EGD which showed duodenitis. Pt's diet has progressed to full liquid. She remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
70 2021-03-03 blood clot right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen ... Read more
right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
70 2021-03-03 heart attack, chest pain severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wh... Read more
severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wheeze; she is also shaky; general malaise; heart attack; and last night she drank some water and choked on it then couldn't get her breath and; chest was hurting radiating to my arm down; fever; chills; exhausted/just felt very tired; her arm that was sore was the one where she had her injection; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9810), via an unspecified route of administration (on left arm) on 15Feb2021 (at the age of 70 -years-old), single dose for COVID-19 immunization. Medical history included asthma, sleep apnea, thyroid problem, prediabetes, cpap use, all from an unknown date. There were no concomitant medications. Patient reported her face is blood red. Last night her chest was hurting radiating to my arm down. It felt like someone was strangling her with water. She noticed my symptoms were what people experience after receiving the second dose. She had fever, chills, exhausted and just felt very tired after receiving the first dose. She still have trouble breathing. She had severe asthma. She was not breathing normally. When she put the mask on it's even harder to breath. She was worried. She thinks, she might have the coronavirus. Consumer says that she is still not feeling well after receiving her first dose of the Pfizer COVID-19 vaccine on February 15th. She says that the first day after getting it, she had pain in her arm, it was achy, it was not really painful enough to where she had to take Tylenol for it. She says yesterday on the second day she had fever, chills, tiredness, general malaise, and today she is not feeling well. Caller says she was having trouble breathing, and did a treatment with her nebulizer which she has because she has real bad asthma. She says her breathing is labored and she wheezes every once in a while. She says she would like to see if there is anything that she needs to do, because she works with children, and if she is coming down with the corona virus she doesn't want to be around them with it. She says that her breathing is problematic today. She says she doesn't think that she is having a severe reaction, she has no rash or those kind of symptoms. She says it seems to be just the asthma, and last night she drank some water and choked on it then couldn't get her breath and her chest hurt and she had pain down her arm and thought oh gosh she was having a heart attack.Caller says she has done no treatments other than the nebulizer treatment. No further details provided about the nebulizer treatment. Caller says the provider said no Tylenol right away, so she didn't take any yesterday with her fever, and she didn't have a thermometer to take her temperature, but her face was really hot and she was having chills, which usually means she has a fever. She says that her arm that was sore was the one where she had her injection. She says that never really was that bad, everyone said their arm had ached, and she has a high pain threshold so it never bothered her. Her wheezing and little trouble breathing was better, after she did some breathing treatments with the nebulizer, she is not breathing well but she is breathing better. She says she is also shaky and doesn't know if that is just nerves, or if this is also something going on. Caller says that it has been a while since she had blood work, which was the last time she went to see physician, but she doesn't know the results for what they found out. The outcome of the events Breathing difficult,wheeze was recovering, other events was unknown.
70 2021-03-03 atrial fibrillation shortness of breath; A fib; Had water in my lungs; This is a spontaneous report from a contactable c... Read more
shortness of breath; A fib; Had water in my lungs; This is a spontaneous report from a contactable consumer (patient self). A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number and expiration date: unknown) via an unspecified route of administration (location: left arm) on 29Jan2021 at age of 70-year-old at single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes. She had known allergies: Penicillin. The patient had a history of atrial Fib (Atrial fibrillation) but had been in sinus rhythm for a long time. No COVID prior vaccination. Concomitant medication included dabigatran etexilate mesilate (PRADAXA). On 30Jan2021 09:00 AM, after first dose of BNT162B2, she went to the emergency room (ER) with shortness of breath and in A fib (Atrial fibrillation), she also had water in her lungs. The events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient stayed for 5 days in hospital. She received unspecified medications as treatment. COVID tested post vaccination (Nasal Swab) on 22Feb2021 resulted negative. The outcome of events was recovering. Information about lot/batch number has been requested.
70 2021-03-04 chest discomfort My last injection was on 1/28/21. That day and few days after I had no site pain. I did have aches... Read more
My last injection was on 1/28/21. That day and few days after I had no site pain. I did have aches and pains and bad headache and chest pressure for hours during the night which I reported and which disappeared next day. However, the site pain in my right arm continues and is pretty bad temporarily and also periodically. Not a big deal but decided to report it. Seems very odd since it's been so long.
70 2021-03-05 fainting Patient was diaphoretic and fainted
70 2021-03-05 fast heart rate Tachycardia, anxiety, difficulty breathing. Cleared by medics.
70 2021-03-07 fainting, loss of consciousness Patient received first Pfizer COVID-19 vaccine on 1/20/2021 and second dose on 2/12/2021. Patient ha... Read more
Patient received first Pfizer COVID-19 vaccine on 1/20/2021 and second dose on 2/12/2021. Patient had minor symptoms such as body aches with both vaccine doses which resolved. Patient then stated she started to experience headache, nausea, and body aches, decreased oral intake, and chill starting on 2/18/2021. On 2/20/2021 patient had several loss of consciousness episodes. Patient presented to the Emergency Department on 2/21/2021 with a chief complaint of syncope, nausea, and vomiting and subsequently admitted to the hospital for potential sepsis, syncope, hyponatremia, dehydration, lactic acidosis. (Continued on second page)
70 2021-03-07 chest discomfort The only treatment I sought was self prescribed...Ibuprofen as needed for fever and fluids As the da... Read more
The only treatment I sought was self prescribed...Ibuprofen as needed for fever and fluids As the days progressed, I feel tightness and heaviness in my chest.. Almost as if there is an upper respiratory infection Thursday evening, I started running a fever and had a sore throat that would not quit Fever was in range of 101 degrees As the day progressed on Friday, the fever returned and spiked to 101 in the evening Saturday more fever in the evening to 102 degrees. Sore throat sort of subsided Constipation set in and has still not resolved itself Today, Monday; I was hoping for relief but none Looking at this report...I am frightened of consequences I am generally in good health
70 2021-03-07 palpitations, chest discomfort Within 25-30 mins after shot, as driving home, I began to feel mildly dizzy, then my throat started ... Read more
Within 25-30 mins after shot, as driving home, I began to feel mildly dizzy, then my throat started to close, (these two symptoms lasted maybe 2-4 seconds and one after another). Then I had a sharp pain in heart area and palpitations/tightness which I have had since then. Chest Tightness/ pressure got worse and on 3/1 taken to ER with heart attack symptoms.
70 2021-03-07 loss of consciousness, fainting began to pass out; because every time I tried to lift my head, I would start blacking out again; diz... Read more
began to pass out; because every time I tried to lift my head, I would start blacking out again; dizzy; diaphoresis; fell against the wall; violent high abdominal pain; n having multiple, large formed bowel movements; shaking; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer. This 70-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EM9809) , via an unspecified route of administration on 12Feb2021 at 09:45 (at the age of 70years old) at single dose for covid-19 immunisation. Medical history included hypersensitive to latex, allergies to levaquin, ddavp, CT scan dye, codeine, fentanyl, primary immune deficiency, myasthenia gravis, Sjogren's, autonomic neuropathy, myelodysplastic syndrome, von Willebrand's, Barrett's esophagus on unknown date and unknown if ongoing and received Pfizer Covid vaccine (dose 1, Lot: EL9261) on 22Jan2021 at 2:45am on left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant concomitant medication was not provided. At approximately 9:50 AM on 12Feb2021, the patient received second Pfizer Covid-19 vaccine in left arm at Administration facility. The patient waited the 15 minutes post injection. At approximately 10:19AM, the patient left site & drove to her home without issues. At home approximately at 11:20am, she had violent high abdominal pain like she never had before. she proceeded to the commode and began having multiple, large formed bowel movements then began to pass out. She began to have diaphoresis and violent shaking and chills. She had passed out on commode and fell against the wall. She later managed to pull pants up and crawl with head hanging down stated that because every time she tried to lift her head, she would start blacking out again. This continued until after approximately 20 minutes. She managed to pull herself up to the couch and raise legs high above heart and head and let head hang off couch to restore blood pressure. The patient mentioned that shot triggered something with her autonomic nervous system. On 22Feb2021, she was still with nausea, fatigue and dizziness. The outcome of events was not recovered. No treatment was received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
70 2021-03-07 palpitations heart racing, possible anxiety. Evaluated by EMS-Cleared
70 2021-03-08 chest discomfort AT 9:30 PATIENT WAS UNABLE TO SWALLOW, MUSCLES IN NECK, THROAT AND JAW WERE VERY TIGHT; COULDNT SWAL... Read more
AT 9:30 PATIENT WAS UNABLE TO SWALLOW, MUSCLES IN NECK, THROAT AND JAW WERE VERY TIGHT; COULDNT SWALLOW OR SPIT. TIGHTNESS MOVED DOWN TO SHOULDERS AND CHEST. PT WENT TO ER ; STARTED SHAKING UNCONTROLLABLY, THIS STARTED AND STOPPED 3 TIMES; ALSO HAD HEADACHE, FEVER AND CHILLS, ER GAVE HER IV BENADRYL AND PT IS STILL TAKING BENADRYL.
70 2021-03-08 pallor Client c/o nausea, weakness and dizziness during observation client appears flush and pale. Client s... Read more
Client c/o nausea, weakness and dizziness during observation client appears flush and pale. Client seen and assessed by EMT. A series of vitals: BP 90/20, HR 43, (2nd), BP 118/90, HR 64, O2 92. (3rd)108/84, HR 60, O2 90, Client advised to go to ER by paramedic. Client's daughter voiced that she will take her mom to ER herself. After 3rd vital assessment was taken client states that she will call her primary Dr. and inform her about the reaction and will follow up with what ever MD advises. Client cleared to go home by EMT.
70 2021-03-08 blood pressure increased, heart rate increased Felt hot, face was flushed, began coughing, throat itched, blood pressure was elevated 184 / 118. H... Read more
Felt hot, face was flushed, began coughing, throat itched, blood pressure was elevated 184 / 118. Heart rate was " fast" but was not told rate, but even. No treatment given ...just monitored for approximately 45 min and sent home when coughing stopped and blood pressure was down to 164 / 106. They did check bp repeatedly, checked o2 levels, blood sugar, heart rate repeatedly. Told cannot return for 2nd vaccine. Primary doctor today verifies cannot have 2nd vaccine due to reaction to first vaccine.
70 2021-03-08 hypertension, palpitations Heart pounding Earrings ringing High blood pressure
70 2021-03-09 heart rate increased 5 nights having nightmares; waking with rapid heart rate; This is a spontaneous report from a non-co... Read more
5 nights having nightmares; waking with rapid heart rate; This is a spontaneous report from a non-contactable consumer (patient). A70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 30Jan2021, at 14:30 (age at vaccination: 70 years) as a single dose for COVID-19 immunisation. The patient medical history included IgA blood deficiency, hypothyroidism and allergy to horse serum. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication included levothyroxine sodium (LEVOTHYROXIN) at 88ug daily, monascus purpureus (RED YEAST RICE), glucosamine hcl + msm (glucosamine hydrochloride;methylsulfonylmethane), calcium, fish oil, loratadine (CLARITIN), minerals nos, vitamins nos (ONE A DAY). The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that during the 2 weeks after the first dose, the patient experienced 5 nights having nightmares and waking with rapid heart rate on 05Feb2021. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events 5 nights having nightmares and waking with rapid heart rate was unknown. No follow-up attempts are possible. No further information is expected.
70 2021-03-10 chest pain Chest pains an hour after shot , lasted 15-20 minutes Shortness of breath 4 1/2 hours after shot,... Read more
Chest pains an hour after shot , lasted 15-20 minutes Shortness of breath 4 1/2 hours after shot, lasted 10 minutes Both symptoms have not recurred since
70 2021-03-10 heart rate increased Elevated heart rate beginning day after 2nd Pfizer dose administered; noted during exercise wearing ... Read more
Elevated heart rate beginning day after 2nd Pfizer dose administered; noted during exercise wearing heart rate monitor; about 15-20 bpm higher than normal; two weeks after 2nd Pfizer dose heart rate is still elevated.
70 2021-03-10 chest discomfort, fast heart rate SV for unstable angina; CAD; Tachycardia; Nausea; Belching; SOB; Chest heaviness, chest pressure, ch... Read more
SV for unstable angina; CAD; Tachycardia; Nausea; Belching; SOB; Chest heaviness, chest pressure, chest tightness; Pain; This is a spontaneous report from a non-contactable other HCP. A 70-year-old female patient received the first dose of bnt162b2 (lot number EN6205) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not provided. Upon 15 minutes after injection, she noted nausea with belching and had some SOB. Symptoms worsened as she ambulated over to the medical bay along with her chest pressure. She denied rash, hives, welts, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient reported recently admitted for unstable angina and CAD with tachycardia. Patient had elevated d-dimer and blood clot was ruled out. Patient discontinued on new medication, beta blocker. Since discharge this Sunday 21Feb2021, she reported chest heaviness as if she has "cardboard on chest." Can slightly increase with going up and down stairs or increased activity. She states she had reached out to her cardiologist via an online site but has not heard back. Patient stated her pain is about the same today. Patient complains of chest tightness and shortness of breath. The outcome of events was unknown. No Follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of events unstable angina and tachycardia cannot be excluded. The patient's age and suspected cardiac condition are risk factors. The event CAD, given its progressive nature, is most likely an underlying condition, thus unrelated to the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
70 2021-03-10 hypertension, cardiac failure congestive my blood pressure was high; Was told that I have Congestive Heart Failure , which I did not have bef... Read more
my blood pressure was high; Was told that I have Congestive Heart Failure , which I did not have before the Vaccines .; watering my lungs; watering my lungs; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (not pregnant) received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration in left arm on 18Feb2021 13:00 at single dose for COVID-19 immunization. Medical history included ongoing high blood pressure, diabetes, penicillin allergy, sinus rhythm (had been in sinus rhythm for a long time), atrial fibrillation. No Covid prior vaccination. Concomitant medication included dabigatran etexilate mesilate (PRADAXA). The patient previously took first dose bnt162b2 in left arm on 29Jan2021 at the age of 70-year-old for COVID-19 immunization and after the first vaccine, patient went to the ER with shortness of breath and in A fib (atrial fibrillation). Had water in patient's lungs, stayed for 5 days. After the second vaccine in Feb2021, patient's blood pressure was high. Back to the ER, watering patient's lungs, Stayed for another 5 days. It was told that patient had Congestive Heart Failure, which patient did not have before the Vaccines. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. The patient was hospitalized for the events for 5 days. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Feb2021, blood pressure measurement: high in Feb2021, blood pressure measurement: high on unknown date. Therapeutic measures were taken as a result of events (unspecified medications). The outcome of the events was reported as recovering. Information on the lot/batch number has been requested.
70 2021-03-11 chest discomfort, chest pain At 3:00 pm 3/11/21 patient's son phoned with patient present stating patient had chest pain and felt... Read more
At 3:00 pm 3/11/21 patient's son phoned with patient present stating patient had chest pain and felt heaviness in chest, this nurse recommended and encouraged patient's son to phone 911 and patient to go to ER. This nurse followed up with patient 3/12/21 1:50 pm and patient was taken to ER 3/11/21 and given nitro, patient then declined diagnostic testing. Pt kept for overnight observation and sent home 3/12/21 10 am.
70 2021-03-13 blood pressure increased 12-14 days after my first dose of the Pfizer vaccine I experiences severe increase in what has been... Read more
12-14 days after my first dose of the Pfizer vaccine I experiences severe increase in what has been very mild tinnitus (from hearing loss) After the second dose (lot EN6200) on Feb 21, 2021 tinnitus became unmanageable causing insomnia, anxiety and blood pressure spike to 155/80. Was treated with Amlodipine --pressure came down but tinnitus not resolved.
70 2021-03-14 blood clot, deep vein blood clot I started to have tingling sensation to my left leg. I have history of DVT, hemochromatosis, hyperth... Read more
I started to have tingling sensation to my left leg. I have history of DVT, hemochromatosis, hyperthyroidism but is all managed. The issue is that the tingling sensation I was experiencing was moving in my left leg, was painful but then it went away. I went to the emergency room 02-25-2021 that started with a blood clot and they placed me on Xarelto medication. My PCP encouraged me to go to the ER. they did an U/S of my left lower extremity which showed blood clot. I am already on blood thinner medication and no one can explain or give me an answer as to why I have a blood clot after my vaccine when i am on blood thinner medication.
70 2021-03-14 blood pressure fluctuation, fainting, atrial fibrillation, heart rate increased syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; sor... Read more
syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
70 2021-03-15 fainting 03/13/2021: Presented to the emergency room after a syncopal episode. Patient admitted for observati... Read more
03/13/2021: Presented to the emergency room after a syncopal episode. Patient admitted for observation and discharged the next day.
70 2021-03-15 haemoglobin decreased, atrial fibrillation, platelet count decreased Patient presented to emergency department in afib RVR with heart rate in 180's. Patient has no known... Read more
Patient presented to emergency department in afib RVR with heart rate in 180's. Patient has no known history of afib, and stated that the heart rate of 180 started several days prior to arriving to emergency department. Patient was given IV push of 15mg cardizem, heart rate came down to 130. Patient then placed on cardizem drip at 10 mg/hr. Afib still present, but heart rate controlled in 120's. Patient underwent transesophageal echocardiography with cardioversion in order to convert patient back to normal sinus rhythm. Patient also stated that she slept for an extra 4 hrs/day for several days following vaccination and developed a scaly rash on injection site. Patient currently admitted in ICU under close monitoring.
70 2021-03-16 loss of consciousness, hypotension 103 temperature, loss of consciousness, low BP. Dizziness.
70 2021-03-16 oxygen saturation decreased I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chi... Read more
I thought I was going to die; Sick; over a 103 temperature/the fever was so high; I had such bad chills; nausea; I would throw it up; arm was so bad, it had it's own pulse, a pulse of it's own, I couldn't lift it at all plus the pain was like a tooth ache pain; checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90; my chest was shortness of breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored program. A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 24Feb2021 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included viruses, flus (I have had viruses, flus my whole life), five surgeries, gallbladder removed, and asthma, all from unspecified dates and unspecified if ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) on an unspecified date, at the age of 70-years-old and experienced a very sore arm. On an unspecified date in Feb2021 the patient experienced, "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath". The clinical course was reported as follows: "I wanted to call today because I got the Pfizer COVID Vaccine 3 weeks ago, 03Feb2021 it was. After the first dose I had a very sore arm and that was it. It was more sore than normal vaccine, but it was that was all I had. After the second dose I was not aware that I would get sick to the extreme that I did. I found out afterwards that other people have said this, I did not know at the time. I thought I was going to die. I am a 70-year-old woman, I am not young, and I have had viruses, flus my whole life and I got so sick. First, I had over a 103 temperature, it came on suddenly, 12 hours to the minute after I got the vaccine. On top of that I had such bad chills I never saw anything like that in my life, 5 blankets on top of me, sweaters, sweatshirts and the fever was so high. I could not keep the Tylenol down because I had nausea and I would throw it up. So, I could not even get rid of it. Then on top of that my arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all, plus the pain was like a tooth ache pain, it was excruciating. I have had 5 surgeries, my arm hurt worse than all 5 surgeries put together. And I had my gall bladder removed and everything, nothing hurt to this extent. Now also I have asthma, nothing severe but I do have asthma, so I have one of those little oximeters and you put it on your finger and it checks your oxygen level and normally its 98-99, it went down to 91, all night it was 91, my chest was shortness of breath. I was ready to go to the hospital. And I did not know it was going to be that bad." When clarified about the treatment the patient stated that "yes, the Tylenol helped once I could hold it down. The doctor gave me something to stop the vomiting and the nausea. And then I could take the Tylenol and then the Tylenol worked great. But at first, I was so sick I could not hold the Tylenol down in my stomach I would throw it up, that was the problem." When asked about lab work the patient stated that she had not had lab work done since the first vaccine. She stated that she had stayed in the house because she had other health issues and was afraid to come out for 11 months. So she had not gone out to get anything done. The patient stated that she called because if a third dose was needed, she suggested that a smaller dose be given to small people. She stated that she took childrens medicine most of the time because she was tiny. She wanted to know if Pfizer in the future would be making doses for small people and doses for bigger people. Her suggestion was to have a separate booster to go by weight or by gender, men usually did not experience the same. The clinical outcomes of the events "I thought I was going to die", "sick", "over a 103 temperature/the fever was so high", "I had such bad chills", "nausea", "I would throw it up", "arm was so bad, it had its own pulse, a pulse of its own, I could not lift it at all plus the pain was like a tooth ache pain", "checks your oxygen level and normally its 98-99, it went down to 91/her oxygen level was down to 90" and "my chest was shortness of breath" were all recovered/resolved on unspecified dates. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
70 2021-03-16 palpitations Palpitations for 10 minutes. Forgot to take HTN meds and is feeling anxious. Denies any HA, dizzin... Read more
Palpitations for 10 minutes. Forgot to take HTN meds and is feeling anxious. Denies any HA, dizziness, CP, or SOB, States she'll go home and take meds. BP 202/110. Doctor consulted and deemed her fit to be released.
70 2021-03-16 loss of consciousness Very high fever (I think), sweating (lost 4 lbs of 123), nausea, passed out. Husband found me on t... Read more
Very high fever (I think), sweating (lost 4 lbs of 123), nausea, passed out. Husband found me on the ground (just a short time), shook me, and I responded. Went to bed, stayed in bed the next day.
70 2021-03-17 lightheadedness thought she would pass out and it went downhill from there; flu symptoms; she got hot; This is a spo... Read more
thought she would pass out and it went downhill from there; flu symptoms; she got hot; This is a spontaneous report from a contactable consumer reporting for herself. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E18982), via an unspecified route of administration on 21Jan2021 13:00 by injection once to left arm at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included apixaban (ELIQUIS) as blood thinner. Patient was calling about COVID 19 vaccine. She had the first shot 21Jan2021, and had had flu symptoms ever since on 21Jan2021 and when they gave the shot they didn't ask for her allergies or anything, and she read on a letter given after, she was taking blood thinners, she was not sure what they do to the vaccine, that wasn't asked of her either, before she decided whether to take second or not, she needed some answers, she hadn't had the flu for 40 years. Her shot was at 1PM, and about 6 or 7PM that night, she got hot and thought she would pass out and it went downhill from there. Patient did not have some medical problems that she checked off when she registered, none of that came through either. Patient was thinking about not taking the second shot if she didn't get some medical information. The outcome of event flu symptoms was resolving, outcome of other events were unknown.
70 2021-03-18 chest discomfort I experienced a red flushing and hives on my face as well as a tightening in my chest
70 2021-03-18 blood pressure fluctuation I immediately stated that the injection made me feel hot. Then my hands and face turned red. The c... Read more
I immediately stated that the injection made me feel hot. Then my hands and face turned red. The clinicians took my BP and it was over 170. They called the ER and took me directly there. The ER doctor administered Benadryl in IV. The redness started to go away and BP returned to normal. There was also a headache. Release from ER 2 hours after event. Subsequent fluctuations in BP and redness over the next 3 days. Saw PCP and he requested that I see allergist to determine cause of reaction in vaccine formula.
70 2021-03-18 blood pressure increased, chest discomfort Patient received second dose of Pfizer at 10:16 AM and was waiting in the waiting area. Reports no ... Read more
Patient received second dose of Pfizer at 10:16 AM and was waiting in the waiting area. Reports no issues with the first does. At 10:39, observer alerted writer that patient stated she wasn't feeling well. Pt was brought back to close observation room. Initial BP was elevated, other VSS. She c/o chest pressure and that she can feel "every vein in my body". Denies any shortness of breath. Reports h/o CAD. Carries nitro with her. At 10:49 AM, reports that chest pressure is increased and now is feeling "tingling all over". States that the pressure doesn't feel as though she need Nitro. Advised that, due to symptoms, would recommend f/u in ED if symptoms continue. At 10:55 AM, Patient requests to be taken to the ED. Husband is accompanying her today. Patient was taken via wheelchair by HCP.
70 2021-03-18 chest pain Short of breath headache chest pain nausea cold symptoms
70 2021-03-21 chest pain The 3rd and 4th day after the first Pfizer shot I had fairly strong pain in my heart /lung area with... Read more
The 3rd and 4th day after the first Pfizer shot I had fairly strong pain in my heart /lung area with every deep inhalation. When I did not breathe deeply, there was less pain, with a bit shortness of breath. There was no problem after the 4th day. The first and second day I had no problems.
70 2021-03-22 loss of consciousness, hypotension 13 hours after injection while sleeping had strong urge to go to the bathroom, bowel movement, resul... Read more
13 hours after injection while sleeping had strong urge to go to the bathroom, bowel movement, resulting in massive diarrhea. During process, became very dizzy and felt nauseous and faint. Attempting to get up from toilet, and getting assistance from husband in an adjoining bedroom, made it to a second bathroom, passing out, again, complete empty of bowels severe diarrhea again while passed out on floor. Unconscious for about one minute, until revived by husband. Sweating, faint, very low BP. Taken to hospital by husband after getting composure admitted for observation due to apparent dehydration from massive diarrhea event. Results possible cardiac instability, dehydration from diarrhea, vegas nerve activity with Discharge the next day 03/22/2021 with follow up with cardiac Dr and primary, ongoing
70 2021-03-22 hypotension Severe Hypotension
70 2021-03-23 fast heart rate Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All ... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/24/2021 Date: 3/24/2021 Subjective is a 70 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated. She felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes and increased in HR. Upon arrival to bay, HR 180-190. Pt's husband states pt with hx of svt. Usually in high 200's or low 300's if it comes on. Hx of having HR in the 150s at times. Usually resolves on its own with elevation of feet above pt's head per pt's husband. He is not worried about it but wanted to know what her pressures were doing. PT with alz. Pt's husband is main caregiver. ALLERGY REVIEW OF SYSTEMS: Redness went away after sitting down.: CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Neuro negative Previous Reactions: none Objective Vitals Vitals: 03/24/21 1045 03/24/21 1101 03/24/21 1115 BP: (!) 141/86 124/80 124/82 Pulse: (!) 180 (!) 158 (!) 150 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is well-developed. Comments: Flushed appearance upon arrival to bay. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Regular rhythm. Tachycardia present. Heart sounds: Normal heart sounds. Comments: HR came down to 150-160's after Trendelenburg position. Ice pack placed on chest. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert. Mental status is at baseline. She is disoriented. Gait: Gait normal. Comments: Disoriented at baseline per pt's husband. Pt able to tell me who her husband is and their plans for cruise this summer. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: water and Trendelenburg position Follow up response to treatment: fair. Patient discharge: AMA. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Discussed pt's HR despite of pt being stable here that they ought to seek further medical care in the ED. Pt husband declines as "she's done this before and I'm not worried. We will go to the hospital if she is not getting better. I think when we get home, in her normal environment, she will be fine." He voices appreciation for our evaluation and concerns. She was able to demonstrate assistance to standing position without reports of feeling dizzy or lightheaded. Pt color does look better. Redness is gone and she continues to report to feel well. Pt wheeled out in wheelchair. Husband is aware of our recommendations. APRN Electronically Signed 3/24/2021 10:59 AM Division of Health
70 2021-03-23 chest discomfort Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5... Read more
Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5 minutes and were followed by an overwhelming weakness, confusion, later also by abdominal cramps, some urinary urgency- all gradually improved over 30-40 minutes. I felt later agitated, had dry mouth, headache- improved after drinking 8-10 cups of water. I did not seek help. I stayed in the shot area in a large tent.
70 2021-03-24 haemoglobin decreased Acute hemolytic anemia of unknown cause - may/may not be related to vaccination
70 2021-03-24 hypotension, lightheadedness After patient received vaccine and waited 15 minutes she asked if she could wait longer because she ... Read more
After patient received vaccine and waited 15 minutes she asked if she could wait longer because she didn't feel well. Paramedic was called and took patient to the EMS tent - per EMS pt was diaphoretic with hypotension and near syncope -after laying down BP normalized and pt resumed normal status. Pt requested to go to the ED. Pt is currently being treated with chemotherapy and had her last dose 5 days prior. She was brought in by EMS after appearing cool, diaphoretic, nauseous, and unwell after vaccine administration. Patient states that she was feeling nauseous, dizzy, and weak 1 hour after administration. She likely had a vasovagal-like response to vaccine administration. Did not lose consciousness.
70 2021-03-24 loss of consciousness Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She ... Read more
Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot; Fatigue; had a low blood sugar episode she supposed; passed out/Unconsciousness; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; crashed unconscious to the floor/fell/fell backwards/caught her foot under the vanity; This is a spontaneous report from a contactable consumer (patient) reporting for herself A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 20Feb2021 11:00 (Lot Number: EN6201) as a SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation. Medical history included breast cancer from 1988 to an unknown date , ovarian cancer from 2015 to an unknown date , she has had lymph nodes removed from her right arm "30 years ago" from 1988 to an unknown date, pass out from unknown date to unknown date. Concomitant medication included olaparib (LYNPARZA) taken for ovarian cancer from Feb2020 at 150mg, 2 tablets in the morning and 1-2 tablets at night by mouth.She says she is a little person and couldn't tolerate the side effects of that, so she varies how many she takes based on her side effects. She says she is supposed to take 300mg in the morning and 300mg at night. She says how she takes it is, she takes 150mg or one pill in the morning, then one or two at night depending on how she is doing. Historical vaccine information included BNT162B2 dose 1, lot no: EL9264, route left arm for Covid-19 immunisation. Past drug history included on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out. The patient reported approximately 15 hours after the shot, on 21Feb2021 she had muscle spasms almost to seizure amount of shaking, full body muscle spasms. She clarifies that her side effects didn't kick in until 02:30AM on 21Feb2021. She says at 07:00AM on 21Feb2021 she got up and went into the bathroom and passed out, and had a low blood sugar episode she supposed. She crashed unconscious to the floor. She said that could be from the shot, but she is also a high risk patient, a cancer patient, and is on a maintenance chemo drug. She says on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out, so she doesn't know if that was related to the COVID shot or not. No testing had been done on high risk patients, so she thought maybe this could be a good heads up for something someone else may experience. Her side effects were on and off for several hours, the shaking and spasms would subside and then start again. She says that they went away, and then she got up and passed out, and her foot was all messed up, she doesn't know what she did when she fell, but she had it checked and it was not broken, it was all bruised and swollen, but it was not broken. She says this was her right foot. She says she thinks she fell backwards, and she thinks she caught her foot under the vanity. On unknown date, she experienced bruising of foot, fatigue, foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot. Outcome of the events was unknown. Information on the lot/batch number has been requested.
70 2021-03-24 hypertension, heart rate increased Full blown cold with sour throat, chills, cough and off the chart blood pressure and heart rate!! T... Read more
Full blown cold with sour throat, chills, cough and off the chart blood pressure and heart rate!! Took 3 days to be some what better, but cough is still with me.
70 2021-03-24 chest pain, very slow heart rate Patient presented 2 days after injection with bilateral lateral chest pain radiating to back, interm... Read more
Patient presented 2 days after injection with bilateral lateral chest pain radiating to back, intermittent, sometimes at rest and sometimes with walking. Had previously been walking 2 miles twice daily, found extreme fatigue stopped her from walking more than 4 blocks with onset at same time. Evaluation included normal CBC w/ diff, ESR, CRP, CMP, LFTs. With pain no better, further eval 3/12 included RUQ U/S ddimer, NT-ProBNP. US showed dilated IVC and hepatic veins, EKG showed only bradycardia at HR 47. Patient eventually agreed to admission, workup for ACS negative with normal echo, clear coronary angiogram. Continuous monitoring showed severe bradycardia with episodes in 20s, pain improved with nitroglycerine. Pa
70 2021-03-25 chest pain 3/26/2021 Ms. Rudd was observed post Covid-19 immunization for 30 minutes based on pre-vaccination... Read more
3/26/2021 Ms. Rudd was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness.chest pain and head ache Assessment : Time of assessment 1707 .Actions taken: increased observation time, VS taken with BP- 125/78. P - 75, O2- 98%, JUICE OFFERED AND DRINKING, TOOK TO STRETCHER VIS WHEELCHAIR TO CONTINUE TO MONITOR. Vs RECHECKED AT520P, 141/75, P- 77. DENIES FURTHER CHEST PAIN OR DIZZINESS. GIVEN WATER, OFFERED TO CALL DAUGHTER BUT PATIENT REFUSED. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 40 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/26/2021 4:25 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
70 2021-03-25 chest discomfort Patient experienced lip tingling, throat tingling, and chest tightness.
70 2021-03-26 heart rate increased Flushed face, rapid heartbeat, minor fever and chilla
70 2021-03-28 pallor, oxygen saturation decreased, chest pain, chest discomfort RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began havin... Read more
RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began having chest pain radiating down her arm, chest heaviness, right arm numbness, and some shortness of breath. Vitals BP:146/78, O2 94% on room air. Patient also pale and diaphoretic. Taken by ambulance to emergency room. Patient has extensive cardia history per EMT report: has pacemaker, had stress test and scheduled for a cardiac procedure. 3/29/21 Phoned patients daughter to follow up with patient's status. Patient does not have cell phone and speaks Bosnian. During hospital stay, she reports her O2 sats were low, had a heart cath. procedure,
70 2021-03-28 blood pressure increased Sitting in the waiting room after the shot, I started to experience difficulty swallowing about 15 m... Read more
Sitting in the waiting room after the shot, I started to experience difficulty swallowing about 15 minutes after shot followed by tingling around both upper & lower lips. Doctor on site saw that I was having an event which he thought was either a TIA or Stroke because my smile was crocked, lip was drooping and BP was very high. The doctor ordered an Ambulance who transported me to hospital as the doctor said they were equipped to handle such an event as they are a Trauma 1 hospital.
70 2021-03-30 pulmonary embolism Three weeks after my vaccine shot I was dx with bilateral pulmonary embolism; This is a spontaneous ... Read more
Three weeks after my vaccine shot I was dx with bilateral pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. None Known allergies. Patient was not pregnant. No other vaccine in four weeks. Historical vaccine included BNT162B2 (product=COVID 19, brand=Pfizer, lot number=EL9261) first dose administered in Left arm on 23Jan2021 01:15 PM. The patient experienced three weeks after her vaccine shot she was dx with bilateral pulmonary embolism on 16Mar2021 06:00 AM with outcome of not recovered. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The patient was hospitalized for the event for 4 days. The patient's hospitalization was prolonged as a result of this event. The patient underwent lab tests which included Nasal Swab (sars-cov-2 test): negative on 17Mar2021. No covid prior vaccination. The treatment received included anti-coagulative therapy.
70 2021-04-03 deep vein blood clot, blood clot right thigh pain Treatment : lovenox 80 sery
70 2021-04-05 pulmonary embolism on 3-11-2021 pt presented to PCP and reported onset around the last week of February 2021. PCP dire... Read more
on 3-11-2021 pt presented to PCP and reported onset around the last week of February 2021. PCP directed pt to ED for urgent evaluation pt was hospitalized x 2 day, treated and sent home on Eliquis.
70 2021-04-06 cerebral haemorrhage, loss of consciousness 4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, des... Read more
4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, described as unusual pain; thought a migraine was coming on. 5-7:00pm headache continues to worsen; chills; research on line side effects of Pfizer vaccine and they coincide with symptoms; 7:05 gets up to urinate (no assistance needed); screams out in pain 3 times while on toilet; starts to vomit; right side of face (eye and cheek and mouth droop like a stroke; left hand starts to curl. Loses consciousness immediately thereafter. 911 call; paramedics on the way; airway was swept and clear; gurgled breathing. Rushed to Hospital and assessed as having massive brain bleed. Pronounced dead at 10:22pm. Acute Hemorrhagic Stroke on Death Certificate.
70 2021-04-06 heart rate increased Rapid heart rate requiring hospitalization and cardioversion (and planned cardiac ablation) six days... Read more
Rapid heart rate requiring hospitalization and cardioversion (and planned cardiac ablation) six days after administration of first vaccine dose.
70 2021-04-06 blood pressure fluctuation, heart attack, heart rate increased, chest discomfort Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, h... Read more
Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, her eyes are weak; Difficulty breathing; thought she was having a heart attack; dehydrated; fast heart beat that felt like her chest was full; fast heart beat that felt like her chest was full; Injection Site Pain; blood pressure fluctuated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (lot number: EN6202; expiration date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure and stroke from 2012 to an unknown date. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for stroke from 2012 and ongoing; clopidogrel bisulfate (CLOPIDA) and simvastatin both taken for high blood pressure from 2012 and ongoing; ongoing amlodipine, lisinopril, and metoprolol all taken for high blood pressure. On 27Feb2021, she took the first vaccine. From that day, for 2 days, she had injection site pain. On 07Mar2021, she started having tiredness, headaches, chills, fever, felt nauseated, had a fast heart beat that felt like her chest was full and thought she was having a heart attack, dizziness, weakness, felt sick, and difficulty breathing. The patient added that she can't see as good, her eyes are weak. She was going to make an appointment to get her eyes checked. For dizziness event, she has to sit on the side of her bed for 10 minutes and she was still dizzy. She has to hold on to something because she feels like she is going to fall. She was given meclizine three times a day for this event. For tiredness event, she stated that it fluctuates during day. After she takes a paracetamol (EXTRA STRENGTH TYLENOL) and lays down for a while, she feels ok and then she feels tired again. For fast heart beat that felt like her chest was full and thought she was having a heart attack event, it comes and goes, she had it yesterday (21Mar2021) but hasn't had it today (22Mar2021) but she doesn't know if it is gone. Her symptoms were usually in the morning when she first gets up. She has been to the emergency room (ER) on 07Mar2021 and on 13Mar2021 and they say that nothing is wrong. On 07Mar2021, they gave her an IV because they thought she was dehydrated. On 13Mar2021, she went back to another hospital ER. She felt worse and her son came and got her and took her to the ER. They did a whole workup MRI of her head, x rays, blood work and everything. They didn't know what was causing it because it had it been over a week since her vaccine and they sent her home. She has been laying down and staying hydrated. She couldn't hardly get up and they asked her what has she done different and the only thing different was the vaccine. Everything listed on the risk factors [side effects] is how she is feeling. She was not hospitalized, they gave her medicine and told her to stay hydrated and sent her home and was told to follow up with her physician. She finally got an appointment for tomorrow (23Mar2021) with her physician. She can't drive because of the dizziness. All of her tests came back normal. They said her blood pressure fluctuated on 2021 but that is normal. Outcome of the injection site pain was recovered on 01Mar2021, of the difficulty breathing was recovering, of the headache, chills, fever, dizziness, weakness, and felt sick was not recovered, while of the remaining events was unknown.
70 2021-04-06 lightheadedness fatigue; mild diarrhea; abdominal pain; gas; runny nose; diarrhea with blood; Sneezing; watery eyes;... Read more
fatigue; mild diarrhea; abdominal pain; gas; runny nose; diarrhea with blood; Sneezing; watery eyes; orange bowel movement; near syncope; lightheaded/lightheadness; chills; body aches; decreased appetite/poor appetite; This is a spontaneous report from a contactable Other-HCP (healthcare professional) in response to HCP letter sent in cross reference case. A 70-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EN6201) intramuscularly on 05Mar2021 (at the age of 70-years-old) as a single dose in the deltoid left for COVID-19 immunisation. Medical history included ongoing HTN (hypertension; onset date: years ago; pertinent details: well controlled) from an unspecified date and menopause from an unspecified date and unspecified if ongoing. Concomitant medications included ongoing hydrochlorothiazide orally taken for HTN from an unspecified date, ongoing estradiol benzoate (ESTRADIOL) vaginal taken for menopause from an unspecified date and ongoing multivitamin orally taken for health maintenance from an unspecified date. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot Number: EL9261) intramuscularly on 12Feb2021 as a single dose in the deltoid left for COVID-19 immunisation and experienced sore arms and should injury. Prior vaccinations were reported as none. On 07Mar2021 the patient experienced diarrhea with blood (medically significant), sneezing, watery eyes, orange bowel movement, on 06Mar2021 the patient experienced near syncope, lightheaded/lightheadness, chills, body aches and decreased appetite/poor appetite, on 08Mar2021 the patient experienced fatigue, mild diarrhea, abdominal pain, gas and runny nose. It was reported that the event near syncope was non-serious, did not require treatment. It was also reported that the events near syncope and diarrhea with blood required a visit to the emergency room. The clinical course was reported as follows: "05Mar2021 Vax. 06Mar2021- Lightheadedness onset day after COVID vax #2. Lightheaded, chills, body aches, decreased appetite. 07Mar2021- Sneezing, watery eyes, orange bowel movement, poor appetite, diarrhea with blood. To ER. 08Mar2021- Fatigue, poor appetite, mild diarrhea, abdominal pain and gas, sneezing, runny nose. 09Mar2021- Improved." The patient underwent lab tests and procedures on 07Mar2021 that included: EKG, CBC and comprehensive metabolic panel which were all normal. The clinical outcome of the event near syncope was recovered/resolved on an unspecified date while the clinical outcomes of the events diarrhea with blood, lightheaded/lightheadness, chills, body aches, decreased appetite/poor appetite, sneezing, watery eyes, orange bowel movement, fatigue, mild diarrhea, abdominal pain, gas and runny nose were all unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Diarrhea bloody cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
70 2021-04-09 loss of consciousness Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had dia... Read more
Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had diarrhea and vomiting (several times in a row).; simultaneously had diarrhea and vomiting (several times in a row).; headache; Slept all day; sore arm; chills; very tired; Fever about 100.5/temp now almost 101; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via unspecified route of administration in left arm on 23Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included prone to bronchitis with bad cold. Known allergies included strong reactions to oxycodone hydrochloride;paracetamol (PERCOCET), zolpidem tartrate (AMBIEN) and some anesthesias. Patient did not have COVID prior vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin, loratadine, ergocalciferol (VIT D) and multi-vitamin. The patient previously received first dose of BNT162B2 (lot number: EN6205) in left arm on 01Mar2021 09:30 AM for COVID-19 immunization. Evening of the shot on 23Mar2021 07:30 PM, patient experienced sore arm, chills, later and very tired. Fever about 100.5. Middle of night, about 16-17 hrs after shot (24Mar2021) awoke with nausea. Rose to go to bathroom and simultaneously had diarrhea and vomiting (several times in a row). Extreme tiredness and nausea. About 4:30 took 2 paracetamol (TYLENOL) and anti-nausea med. Passed out in bed on 24Mar2021. Woke about 11:30 AM. temp now almost 101, headache, paracetamol and more anti-nausea med. Slept all day until 10:45 PM 24Mar2021 fever normal, nausea gone, quite tired still. On 25Mar2021, patient was able to get up, still tired but so much better, stomach still queasy. Ate bit of toast, later, rice and applesauce. Bit of headache took paracetamol. Very difficult to fall asleep that evening (25Mar2021), awoke 26Mar2021 and fell so much better although stomach still a bit queasy. Treatment was received for all events. Patient had not tested COVID post vaccination. The outcome of events was recovering.
70 2021-04-09 atrial fibrillation heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute.... Read more
heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute. In the emergency room an electrocardiogram showed atrial fibrillation; This is a spontaneous report from a non-contactable consumer (patient). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 07:45 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. Medical history included allergies to medications of Clindamycin, Penicillin, Amoxicillin, Statins and hypertension (controlled on medication), type 2 diabetes (diet controlled), obesity, obstructive sleep apnea, thyroid nodules benign. Concomitant medication(s) included metoprolol (METOPROLOL), fosinopril (FOSINOPRIL, furosemide (LASIX [FUROSEMIDE]), niacin (NIACIN) and bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 07:45 (Batch/Lot Number: EN5318) as single dose for covid-19 immunisation. On 20Mar2021 18:00, the patient started to have heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute. In the emergency room an electrocardiogram showed atrial fibrillation. Cardiac, thyroid and all other labs were normal. Atrial fibrillation resolved in the emergency room without treatment. Discharged to home, appointment in clinic on 23Mar2021 with a cardiologist, who ordered Cartia XT (started 23Mar2021) and Eliquis (started 23Mar2021 after stress test). On 24Mar2021 a cardiac echo and a myocardial profusion imaging stress test were completed and results on both tests were reported as being normal. There was no past diagnosis of atrial fibrillation or of the above symptoms of heart palpitations and rapid irregular heartbeat. The symptoms have not been experienced since the initial episode on 20Mar2021. Plans are to remain on Cardia XT and Eliquis, and to be seen on 23Jun2021 in the cardiology clinic for an electrocardiogram and an appointment with the cardiologist. Therapeutic measures (Cartia XT 120mg per day, Eliquis 5mg two times a day) were taken as a result of the event. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Mar2021 the event was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
70 2021-04-09 chest discomfort loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach ... Read more
loss of appetite; pretty bad headache; body aches; tightness in her chest; Ringing in ears; stomach cramps; slept 15 hours; lump; pimple; infection on the abdomen; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 24Feb2021 (Lot Number: EN6202) as SINGLE DOSE for COVID-19 immunization. Medical history included a lot of allergies from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for high blood pressure, start and stop date were not reported; formoterol fumarate, mometasone furoate (DULERA) taken for bronchial hyperreactivity, start and stop date were not reported; fluticasone to help her breathe, start and stop date were not reported; fexofenadine a decongestant for allergies, start and stop date were not reported; tolnaftate antifungal solution for toenail, start and stop date were not reported; and fluorometholone taken for plugged up tear duct, start and stop date were not reported. The patient previously had flu shot once about 15 years ago and it was terrible. With the first dose, the patient started to have loss of appetite, pretty bad headache, body aches, tightness in her chest, ringing in her ears, and stomach cramps. She slept 15 hours the first night. She got up to go the bathroom and then went right back to bed. That happened after first dose and she wasn't too anxious to get the second dose. These were pretty strong. For 24 hours after onset they were pretty severe. Then she experienced variation of these and lessening of severity over seven days. By the next Wednesday she felt her normal self. She got both shots on Wednesday. She didn't have fever or any other problems that COVID people get. The patient had an infection on the abdomen. She took Cephalexin for 10 days. The infection on the abdomen started in early Mar2021. It was like a lump in Mar2021. She went to the dermatologist because there is cancer in her family. The dermatologist told her not to worry. Then it erupted like a big pimple in Mar2021. The outcome of the events was unknown. Follow-up attempts are needed. Information on lot/batch number is available.
70 2021-04-15 cardiac failure congestive Date and time of vaccination: (list both if they received both shots): 02/02/21 1100, 02/23/21 1200... Read more
Date and time of vaccination: (list both if they received both shots): 02/02/21 1100, 02/23/21 1200 Date and time adverse event started: 02/05/21 1100 SOB AFTER FIRST SHOT ,FATIGUE , WAS ADMITTED TO HOSPITAL FOR 7 DAYS , RELEASED AND THEN RETURNED TO THE HOSPITAL , SENT BACK TO , SAW THE DOCTOR 24TH OF MARCH , DOCTOR ADVISED WATER REDUCTION AND THE PATIENT HAD DEVELOPED CHF , PATIENT PAST ON THE 29TH
70 2021-04-15 cerebrovascular accident I had a stroke.
70 2021-04-15 palpitations, atrial fibrillation, chest discomfort Immediate headache, heart racing, weakness, chest sensations, palpitations, nausea, After two weeks... Read more
Immediate headache, heart racing, weakness, chest sensations, palpitations, nausea, After two weeks of continued symptoms suddenly had Afib with RVR event and went to Er
70 2021-04-17 blood clot, chest pain Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both... Read more
Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both upper and lower parts collapsed); Lower chest partial atelectasis or scarring in the lung bases bilateral; Beneath this area was a red circle where blood clotted or something; Wheezing; Shortness of breath; Swelling of the face; underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red; underneath the arm where the injection site was, a big red circle was noted and it was swollen; I would get hot and cold; I was sweating; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Fatigue; Pain in left elbow; goes to bathroom and bowel was not emptying the way it should; rib cage is going on the side of body noticed this thumping; Her lips were red; Throat was red; Been sick and just laying around; Her eyes were red; Cramp in left arm where site of injection; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; This is a spontaneous report received from contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 15Mar2021 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included lung issues and allergic asthma. Family history included brothers and sisters who died of lung issues and third sibling sister died many years ago due to allergic asthma. The patient previously took flu vaccine for immunization and experienced severe pain throughout her whole body. On 15Mar2021, patient received the first dose of Pfizer COVID-19 vaccine. Later on, that day when she got home after receiving the vaccine, underneath the arm where the injection site was, a big red circle was noted and it was swollen, beneath this area was a red circle where blood clotted or something, she would get hot and cold and take her clothes off because she was sweating but did not have fever, there was pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow. She goes to bathroom and bowel was not emptying the way it should. She also noted that her rib cage is going on the side of body noticed this thumping, lips and throat were red. She's been sick and just laying around, her eyes, under her nose and left elbow were red, had cramp in left arm where site of injection, and sharp pains were hitting her in her eye, thigh, chest, head, and the arm. Patient clarified that these symptoms began on 15Mar2021, the same day she received the Pfizer COVID-19 vaccine. On 23Mar2021, patient went to the ER and the findings were lower chest partial atelectasis or scarring in the lung bases bilateral and partial lung collapse (both upper and lower parts collapsed). At the hospital her temperature was 98.9 F on 23Mar2021, but 97.1F - 97.7F is her normal temperature. She went to the Pulmonary doctor also, but was getting a second opinion because she knew it could be life threatening. The pulmonary doctor made light of it saying they were just creases, like creases in pants. Patient said crease was a far cry from partial lung collapse on both bases and the Pulmonary doctor also said that it is in the upper part of the lung also. This scared her and made her think nobody cared. She did not know if she should provide the information because the doctor did not seem to believe that that her symptoms were coming from receiving the Pfizer COVID-19 vaccine. She guessed she should provide the information because Pfizer does research. She wanted to know how long do the side effects last and if she should take the second dose. The outcome of the events underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red, pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow, goes to bathroom and bowel was not emptying the way it should, rib cage is going on the side of body noticed this thumping, lips were red, throat was red, been sick and just laying around, eyes were red was not recovered; while unknown for the other events. Information on the lot/batch number has been requested.
70 2021-04-17 chest pain, hypertension she ended up in the hospital her blood pressure was way up, it was at 188; pain in chest; feeling si... Read more
she ended up in the hospital her blood pressure was way up, it was at 188; pain in chest; feeling sick and stuff; on her right arm she has a hidden rash between her hand and her elbow; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EP6955), via an unspecified route of administration, administered in the left arm on 22Mar2021 at 16:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EN6198) on 25Feb2021 at 15:00 on the left arm for COVID-19 immunization and reported that her blood pressure went sky high and it continued to be high and her heart rate was up and caused her to go to urgent care. The patient also previously received a flu vaccine on an unspecified date and her arm was sore for 3 weeks and she felt like she had the flu for 3 days. The patient reported that after she got her second vaccine she had the normal, what people call normal reaction, of feeling sick and stuff on 27Mar2021 then she ended up in the hospital her blood pressure was way up, it was at 188 and she forgets what the bottom number was. She went in because she felt like she was having a heart attack there was a pain in chest like right where the middle of a bra would be. It lasted about 15 or 20 minutes. That is her experience with the vaccine, it is raised blood pressure and she is still dealing with it her blood pressure is still high. She tries not to be scared but the doctors at the hospital made her a little nervous that is why she spent the night but that is a definite side effect. The patient was admitted to the hospital on 27Mar2021 and was discharged on 28Mar2021. They wanted to keep her for 2 nights and do a stress test and she said no way she is not staying for 3 nights in that hospital, the nurses were outstanding they were the most efficient nurses but the hospital food sucked and she got no sleep. Also, on her right arm she has a hidden rash between her hand and her elbow under the skin there is a rash that popped up with the vaccine on an unspecified date in Mar2021. The patient also stated that her blood type is O negative and she does not know she heard that O neg people weren't going to get COVID and she has never got COVID before. The patient also reported that they drew blood 6 times in the hospital to see if she had a heart attack and everything came back negative. it just so happens she had a echocardiogram the day after the first dose was given and her blood pressure was elevated that day but everything was fine. She says it is not relevant but she tested for that out of precaution, her doctor asked her to do that every 2 years and just so happened to fall on the day after the first dose. The patient received treatment for the events she ended up in the hospital her blood pressure was way up, it was at 188, felt like she was having a heart attack and pain in chest. The outcome of the event she ended up in the hospital her blood pressure was way up, it was at 188 was not recovered while the outcome of the other events was unknown.
70 2021-04-18 fainting On the morning of Friday 4/16/21, patient came to vaccine clinic to let us know that his wife passed... Read more
On the morning of Friday 4/16/21, patient came to vaccine clinic to let us know that his wife passed away the night of her second dose of her Pfizer covid vaccine. He states that she complained of arm pain at the injection site that evening (4/14/21) and went to bed around 9:30pm because the pain was excruciating. He said around 2:00am, she woke up stating she couldn't breathe. This has happened before, so she went and sat up in the living room which helped her last time. For whatever reason, she then went into her bedroom where he said she fell out. He noticed foam coming from her mouth and called 911. EMS was unable to revive her. She passed away at home.
70 2021-04-20 chest discomfort lungs feel congested; Chest tightness; chills; fever; inflammation; This is a spontaneous report fro... Read more
lungs feel congested; Chest tightness; chills; fever; inflammation; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Right arm on 03Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Asthma, hypertension, covid prior vaccination. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); montelukast sodium (SINGULAIR); losartan; HCTZ; unspecified product "D". The patient previously took erythromycin and experienced allergy. The patient received the first dose of bnt162b2, at the age of 70-year-old, via an unspecified route of administration, administered in right arm on 13Mar2021 11:00 as single dose for covid-19 immunization and experienced fatigue and sore arm. The patient experienced lungs feel congested, chest tightness on 04Apr2021 03:00; chills, fever and inflammation on 03Apr2021. Chills and fever Sat. night into Sunday, fever lasted until Monday 05Apr. Chest tightness, lungs feel congested. Went to doctor, he thought inflammation from vaccine. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The patient was not pregnant. The outcome of the events Fever was recovered on 05Apr2021, other events was recovering. Information on lot/batch number has been requested.
70 2021-04-22 cardiac failure congestive, hypotension Hospice Care Sepsis associated hypotension Discharge Diagnoses: acute on chronic hypoxic/hypercapn... Read more
Hospice Care Sepsis associated hypotension Discharge Diagnoses: acute on chronic hypoxic/hypercapnic resp failure requiring intubation, acute on chronic CHF, severe COPD with likely exacerbation, possible CAP, likely medical non compliance
70 2021-04-28 transient ischaemic attack Having headaches every day since this has happened; Had TIA (memory loss); Have no memory of 24 hour... Read more
Having headaches every day since this has happened; Had TIA (memory loss); Have no memory of 24 hours, could not answer any questions had lost memory; This is a spontaneous report from a contactable consumer (patent). A 70-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 04Mar2021 09:45; at the age of 70-years-old, (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient received the first dose of bnt162b2 on 02Feb2021. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. No Covid tested post vaccination performed. The patient experienced Transient ischaemic attack (TIA) on 13Mar2021 and was admitted to hospital, she could not answer to any questions and had lost memory. The patient had no memory of 24 hours, could not answer any questions had lost memory. She also complained headaches every day since this has happened (as reported). The reported events were headache (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae, Transient ischaemic attack (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae, Amnesia (have no memory of 24 hours), (hospitalization, life threatening) on 13Mar2021 09:00 with outcome of recovered with sequelae. Information on the lot/batch number has been requested.
70 2021-04-28 platelet count decreased platelets have been significantly dropping/platelets were down to 4,000 units; platelets have been s... Read more
platelets have been significantly dropping/platelets were down to 4,000 units; platelets have been significantly dropping/platelets were down to 4,000 units; Really Weak; This is a spontaneous report from a contactable consumer (patient's daughter). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization. Medical history included ongoing thrombocytopenia (diagnosed 4-5 years ago). No concomitant medications. Family medical history included high cholesterol. The patient previously received the first vaccine dose of BNT162B2 on 23Feb2021 for COVID-19 immunization. No adverse event (AE) following prior vaccinations. The patient's daughter stated that the patient seemed like she was having an adverse reaction since her second vaccination. The patient's daughter said that this started after her mother received the second dose of the Pfizer-BioNTech COVID-19 Vaccine last 16Mar2021. The patient's platelets have been significantly dropping. The patient was rushed to the hospital because platelets were down to 4,000 units. The patient had thrombocytopenia but was managed well. The patient has Thrombocytopenia Disease and her hematologist recommended that she get the vaccine. Before the second vaccine, her platelets had been stable, not at normal range, but 78,000 to 71,000, which was normal for her. After the vaccine, the patient's platelet level has been significantly plummeting to single digits like 4,000 and then in a few hours shooting to 31,000 (in Mar2021). It was a consistent up and down for her. The patient was rushed to the hospital from her doctor's office and she was being admitted because her platelet level was down to 4,000 and she was getting a platelet transfusion. Ever since the patient got the vaccine, this started happening. Before, only once in a 3 year span, the patient's platelets dropped to 6,000 and now this is happening very often. The patient felt really weak for the last 2 days since 19Mar2021 (as reported) especially but it really started the same time as her platelets first dropped, so they took her to see the hematologist and fortunately they were able to get her in and did a complete blood count (CBC) and her platelets were down to 4,000 on 19Mar2021 (as reported). The treatment included Platelet Transfusions and was given steroid medication (they haven't received it yet but she was prescribed Promacta by Novartis). The patient has been in and out of the hospital 3 times within 2 weeks. Within a 2 week time frame, the patient has been there 3 times, 2 direct admit hospitalizations and 1 emergency room (ER) visit. She was rushed to the ER on either 05Apr2021 or 06Apr2021, but she was not admitted because when they took her labs at the doctor, her platelets were 4,000, but when they were rechecked in the ER they were 38,000 so the released her because it came up and was over 30,000. The patient was admitted to the hospital from her doctor's office on 09Apr2021 and released 10Apr2021. She was admitted to the hospital again on 14Apr2021. Event occurred after the second vaccine dose. The patient had a visit to physician's office for a couple of times. The outcome of the events was not recovered. Information on Lot/Batch number has been requested.
70 2021-05-04 hypertension, heart rate increased, blood pressure fluctuation first dose, her blood pressure went sky high and it continued to be high; first dose, her heart rate... Read more
first dose, her blood pressure went sky high and it continued to be high; first dose, her heart rate was up; tired; Blood pressure continues to fluctuate daily; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (age at vaccination: 70-year-old) received the first dose of bnt162b2 (BNT162B2, lot EN6198), via an unspecified route of administration in left arm, on 25Feb2021 16:00 as SINGLE DOSE for Covid-19 immunisation. Medical history was none. There were no concomitant medications. On 27Feb2021, her blood pressure went sky high and it continued to be high (reported as medically significant, disability) ending up in urgent care. She doubled her blood pressure medication which she did, she took Carvedilol and she could only take 2 of the double dose at night because she took 2 in the morning. On 27Feb2021, her heart rate was up (135) and felt tired. Her blood pressure continued to fluctuate daily (Feb2021). The patient underwent laboratory tests and procedures which included blood pressure measurement: high, 178/109, 168/98 on 25Feb2021, blood pressure measurement: went down to 60 on unknown date, blood test: negative on heart attack and everything came back negative, blood test: ok on 26Feb2021, blood test: ok on 27Feb2021, echocardiogram: ok, electrocardiogram: ok on 26Feb2021, electrocardiogram: ok on 27Feb2021 (all urgent care to check for blood enzyme for heart attack), heart rate: was up (135) on 25Feb2021. The outcome of the events was unknown. Information on the lot number was already obtained.
70 2021-05-04 cardiac arrest low immune system; cardiac arrest; Swelling/foot got swollen; This is a spontaneous report from a co... Read more
low immune system; cardiac arrest; Swelling/foot got swollen; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization; immunoglobulin human normal (HIZENTRA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. The patient had unspecified concomitant medications. On 20Apr2021, the patient experienced cardiac arrest, which was noted as a medical emergency with outcome of unknown; swelling/foot got swollen on 20Apr2021 with outcome of unknown; low immune system on an unspecified date with outcome of unknown. The consumer reported the events as non-serious. Details were as follows: patient had a medical emergency (cardiac arrest), with swelling and she was administered with a steroid injection Decadron and was prescribed furosemide (LASIX) 40mg tablets for 5 days. Patient reported that she has an immune support CBIs. The medical emergency she experienced the day prior was a reaction to the medication Hizentra for low immune system, so it was suspended. The action taken in response to the events for BNT162B2 was not applicable, and for immunoglobulin human normal was permanently withdrawn on an unspecified date. Therapeutic measures were taken as a result of swelling/foot got swollen as aforementioned. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
70 2021-05-10 heart attack Heart attack; This is a spontaneous report from a non-contactable consumer (patient). This 70-year-o... Read more
Heart attack; This is a spontaneous report from a non-contactable consumer (patient). This 70-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in right arm on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Covid-19 test was negative. The patient had a heart attack four days after first vaccination. The adverse event result in emergency room/department or urgent care and received treatment. Seriousness criteria was caused/prolonged hospitalization for 4 days, not results in death, not life threatening, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
70 2021-05-13 heart rate increased bumps on arms; Atypical Pneumonia; elevated heart rate; Headache; Sleepy; tired; This is a spontaneo... Read more
bumps on arms; Atypical Pneumonia; elevated heart rate; Headache; Sleepy; tired; This is a spontaneous report from a contactable consumer (reported on herself). A 70-year-old female patient received first dose of BNT162B2 (solution for injection, Lot number: EN6202 expiry date: unknown) via an unspecified route of administration in left arm on 02Mar2021, as a single dose of COVID-19 immunization. Medical history included COPD, Asthma: She had a cough for two years and had acid reflux which was when they diagnosed her with asthma, Coughing started 1-2 hours after that flu vaccine which she received in 2019, she did not have the NDC number, lot number, or expiration. The caller had not received a flu vaccine since. She was diagnosed with Lichen sclerosus 3 months prior to this report, pneumonia diagnosed 4 years prior to this report, and she believed it was autoimmune. Concomitant medication included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (Trelegy) inhaler dosage text: 1 inhalation a day, 200mcg been taking it a couple of months for asthma and COPD. On 02Mar2021, she had her vaccine in the morning and by the afternoon her heart rate was high at the appointment with her asthma doctor and her heart rate had been elevated ever since. She then noticed bumps on both of her arms when she was getting out of the bath. Her heart rate was still elevated so she went to the Emergency Room a day prior to this report and was diagnosed with atypical pneumonia. She had a headache, she took a Tylenol, and little bumps on both of her arms. The bumps did not itch, but they were still there. Her doctor put her on antibiotics (unspecified). The patient was she was tired and sleepy from the vaccine but did not feel quite so groggy. She did not feel good a week prior to this report, she thought it was something she ate, she was going to reschedule vaccine because of it. She had blood tests (unspecified) done a day prior to this report, in the Emergency Room and they all came out okay, she guessed. She did not have history of previous immunization with the Pfizer vaccine and was not administered additional vaccines on same date of the Pfizer Suspect. She did not have a family medical History relevant to events. The outcome of the events of atypical pneumonia, elevated heart rate, bumps on arms, and headache was not recovered, however the outcome of the events tired and sleepy was unknown. No further information was available.
71 2021-01-07 fast heart rate Onset of tachycardia 5 minutes after injection which lasted 10-15 minutes. Resolved by itself.
71 2021-01-10 fast heart rate After receiving the vaccine client verbalized tachycardia, dizziness and light headedness. Client w... Read more
After receiving the vaccine client verbalized tachycardia, dizziness and light headedness. Client was evaluated by onsite paramedic. Client was transported to Clinic for further evaluation due to unresolved symptoms at 4:24 pm. In addition client verbalized no allergies when asked by intake nurse.
71 2021-01-10 chest discomfort Chest tightness, body aches, fatigue
71 2021-01-10 blood pressure increased Patient's reaction(s) noted during COVID vaccine observation period: Shortness of breath, throat tig... Read more
Patient's reaction(s) noted during COVID vaccine observation period: Shortness of breath, throat tightness Actions Taken: Pt felt better within a few seconds. She thinks it was anxiety/panic attack after receiving her vaccine as the tightness/SOB only lasted a few seconds. She was walked by an RN from the vaccine administration area to observation area and took a set VS. VS were normal with a slightly elevated SBP. Pt stayed in observation area for a little longer to make sure she felt okay. Pt went home, declined ED visit
71 2021-01-13 chest discomfort Patient presented to the COVID clinic today January 14, 2020 for her first COVID-19 vaccine. She wa... Read more
Patient presented to the COVID clinic today January 14, 2020 for her first COVID-19 vaccine. She was given 0.3 mls of the vaccine IM in the left deltoid.at 2:40 pm. She pulled around to the observation area and at 2:45 she reported that she was experiencing her lips tingling along with chest pressure and SOB. Spo2 was 96% on RA. Oxygen applied via face mask at 4 L.. Sp02 then went up to 99%. At 2:50 BP was 122/80. At this time she reports that the chest pressure has subsided but that she was still experiencing some fuzziness in her eyes. She denies any itching. At 2:53 she reports that her lips are not as numb but that she still has some fizziness. At 2:58 she reports that she feels "real tired" and that she is not as "fuzzy headed". Patient continued to improve. At 3:09 oxygen was removed. Sp02 stayed at 98%. After observing patient for several minutes she was found to be in stable condition to leave the observation unit. She was agreeable to this plan. She will notify her PCP with any further symptoms.
71 2021-01-13 fainting Systemic: Fainting; symptoms lasted 1 day
71 2021-01-17 fast heart rate CO SOB, light headedness and tachycardia HR 110 BP 150/palp, O2 Sat 94% on RA Provided O2 @ 2liter... Read more
CO SOB, light headedness and tachycardia HR 110 BP 150/palp, O2 Sat 94% on RA Provided O2 @ 2liters via NC. Patient reported reduction in symptoms within a few minutes and discharged to self with husband. At discharge HR 83, BP 150/96, O2 Sat 93% on RA
71 2021-01-17 chest discomfort the patient describes "chest tightness"
71 2021-01-19 low blood oxigenation Pt admitted to hospital on 1/4 with epigastric abd pain and tested positive for COVID. Discharged to... Read more
Pt admitted to hospital on 1/4 with epigastric abd pain and tested positive for COVID. Discharged to recover at home on 1/6. Presented to different hospital 1/12 with progressive SOB. Remains admitted, being treated for Acute on chronic respiratory failure with hypoxia due to COVID-19 pneumonia.
71 2021-01-20 chest discomfort Tightness in chest , Hives, weakness, required visit to E.R. Given IV Benadryl Pepcid, prednisone
71 2021-01-24 hypertension, palpitations Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: fa... Read more
Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: face swollen, blotchy, numb eyes swollen, sore sockets, upper lip puffed out, burning face feel, asthma
71 2021-01-25 heart rate increased 1:45 warmth of entire left arm and felt anxious, felt elevated heart rate and shakey b\p 190/90 hea... Read more
1:45 warmth of entire left arm and felt anxious, felt elevated heart rate and shakey b\p 190/90 heart rate 90 2pm 176/72 heart rate 90 sat up 160/90 gave OJ to drink released 2:30 178/88 heart rate 80 Instructed to seek medical attention if further problems. Was walked to car
71 2021-01-25 palpitations, chest discomfort Attendee reports 5 minutes post vaccine chest tightness, palpitations and apprehension. No other sym... Read more
Attendee reports 5 minutes post vaccine chest tightness, palpitations and apprehension. No other symptoms. EMS notified and transported to local hospital for evaluation
71 2021-01-25 cerebrovascular accident Began experiencing left sided weakness, Evaluated in ER, Medivac'd to other facility for stroke
71 2021-01-25 palpitations, blood pressure increased Felt dizzy and "heart racing", elevated BP noted with Afix on monitor. Patient felt "symptoms" at 1... Read more
Felt dizzy and "heart racing", elevated BP noted with Afix on monitor. Patient felt "symptoms" at 15 minutes with periods of Afix and normal sinus on the monitor. Vitals and on going monitoring completed. Patient verbalized history of chronic Afib. No other symptoms and no distress noted otherwise. Patient and family declined ER treatment or further medical evaluation.
71 2021-01-27 fainting Patient received first dose of covid vaccine on 1/28/21. Reported dizziness, fainting, and mild shor... Read more
Patient received first dose of covid vaccine on 1/28/21. Reported dizziness, fainting, and mild shortness of breath.
71 2021-01-30 blood glucose increased several unusual symptoms started 6 days after immunization: sudden, painful outbreak of cold sores, ... Read more
several unusual symptoms started 6 days after immunization: sudden, painful outbreak of cold sores, stiff, not painful joints, tiredness, and (the most unusual) is an elevation of my blood glucose to at and above 180 for about 24 hours (I have used a continuous glucose monitor for the past 7 months and have learned food/body responses and usually drop into the 120 range over night. i have daily graphs for the time represented here). No treatment except caution on food and continued regular medications, outcome. All these symptoms stopped about 48 hours later on Saturday, Jan 30, 2021. I am reporting for information only regarding this new vaccine. I intend to take my second, booster dose in the regular 3 week interval. Did not consult physician nor clinic.
71 2021-01-31 heart rate increased nauseous; threw up all day; heart races a little bit in the middle of the night/her heart also went ... Read more
nauseous; threw up all day; heart races a little bit in the middle of the night/her heart also went racing a few times in the night; sinus pain; dizziness/like she was not dizzy today like she was yesterday, but today she was just more like lightheaded; Low grade fever; feeling sick/doesn't feel good; head hurts really bad/terrible headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EH9899, expiration date Mar2021) via an unspecified route of administration on 09Jan2021 at a 0.3mL via injection into the left arm for covid-19 immunization. The patient stated that she had Type 2 diabetes which diagnosed about 10 years ago and high blood pressure diagnosed about 20 years ago, so her providers office sent her a text saying the doctor wanted her to have the vaccine. She confirmed that she had no other vaccines on the same day as the COVID vaccine. The patient stated that she had high cholesterol about 5 years ago and her doctor initially put her on Lipitor, but she got to a point where she could not walk, so her doctor put her on something else, but she could not tolerate that either, so then she was switched to the Pitavastatin Calcium. The patient stated that she also had a very sensitive stomach, but she cannot think of the name of what she was diagnosed with because since she had her a couple of seizures started about two years ago this upcoming Aug, she can't think straight. The patient also had GERD about 5 years ago, macular degenerative disease a couple of months ago. All medical condition was still ongoing. Current concomitant medications included levetiracetam (KEPPRA, Tablet) 500mg, once daily, by mouth started from about two years ago, this upcoming Aug for seizures; metformin 1000mg, two tablets daily, by mouth started from about 10 years ago for Type 2 diabetes; allopurinol Tablet 300mg, once daily, by mouth started from probably 2 or 3 years ago for her kidney; metoprolol tartrate (LOPRESSOR, Tablet) 50mg, once daily, by mouth started from 2 years ago for high blood pressure; empagliflozin (Jardiance, Tablet) 25mg, once daily, by mouth has been on this product about 6 months for Type 2 diabetes; lisinopril Tablet 40mg, once daily, by mouth started from probably about 10 years ago for high blood pressure; diltiazem hydrochloride (CARDIZEM CD, 24 hour Capsule) 180mg, once daily, by mouth started from a couple years ago; omeprazole magnesium (Prilosec, Capsule) 20mg, once daily, by mouth started from probably about 4 years ago for GERD; hydrochlorothiazide Tablet 25mg, once daily, by mouth started probably about 10 years ago for high blood pressure; Vitamin D 125mcg or 5000unit Tablet, once daily, by mouth as Vitamin supplementation started taking this about a year ago. The patient had a blood test where her Vitamin D was a little low. Vitamin C was got it over the counter; PreserVision OTC medication, with Vitamin A, E, C, zinc and copper Two capsules by mouth daily started from about two months ago for macular degenerative disease; pitavastatin calcium Tablet 2mg, once nightly, by mouth for High cholesterol; it was on it before, but started back on it a couple months ago. The patient reported she doesn't feel good and got headache on 11Jan2021, had dizziness and low grade fever on 15Jan2021, had nausea and threw up, sinus pain and heart races a little bit on 17Jan2021. She did not want to go through this again. The patient stated that she had the first shot of the Pfizer COVID Vaccine on 09Jan2021. She felt for a day and a half by Monday, 11Jan2021, she has been sick ever since, she did not feel good at all. She had a terrible headache, and for probably one or two days, she ran a low-grade fever. Her headache was still ongoing, but it had eased up because she was taking Tylenol. The patient stated that the dizziness she had, caused her to be nauseous and she threw up all day yesterday. She tried to eat something today and she was just having bad problems with feeling sick all the time. She asked if there are recommendations for getting the second shot after having symptoms like this. Today is the third day that she had been feeling the dizziness and it had improved a little, like she was not dizzy today like she was yesterday, but today she was just more like lightheaded. The patient reported that the nausea was ongoing, she felt like she was going to get like today like she did yesterday. She did not think she still has a low grade fever, she probably had the low grade fever on 15 and 16Jan2021. She just can't seem to shake not feeling good. At first that it was her sinuses because that was where her head was hurting, but then the sinus pain went away but she still had a headache. The patient stated that her heart also went racing a few times in the night. Yesterday was a bad day, but today she was a little bit lightheaded. She tried to eat some toast today, so she will see if she can keep that down. The outcome of the events headache, dizziness, heart rate increased and sinus pain was recovering and the low grade fever was recovered on 17Jan2021 and other events was not recovered.
71 2021-02-01 fainting syncopal episode
71 2021-02-02 cardiac arrest Cardiac Arrest with in an hour of receiving Covid vaccine; Brought into ED by EMS doing CPR; resusci... Read more
Cardiac Arrest with in an hour of receiving Covid vaccine; Brought into ED by EMS doing CPR; resuscitation continued in ED for 20 minutes before ROSC was achieved. Pt admitted to Critical Care.
71 2021-02-04 heart rate increased, atrial fibrillation her heart went into atrial fibrillation (AFib) and heart rate was up to 155; This is a spontaneous r... Read more
her heart went into atrial fibrillation (AFib) and heart rate was up to 155; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. Medical history included blood cholesterol abnormal, atrial fibrillation and ongoing high blood pressure.Concomitant medication included losartan for high blood pressure, atorvastatin for cholesterol, gabapentin, hydrochlorothiazide (HYDROCHLORZIDE). The patient experienced her heart went into atrial fibrillation (AFib) and heart rate was up to 155 on 20Jan2021 with outcome of unknown. The patient went to the hospital last night on 20Jan2021 and corona virus test that was negative last night.The patient stated she was still in the hospital, until 21Jan2021. (Dates of hospitalization was not available over the call, hence hospitalization was checked as seriousness criteria). The patient received a medicine that they put in the drip, IV, to lower her heart rate. Information about lot/batch number has been requested.
71 2021-02-05 blood pressure increased Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red ... Read more
Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red flushing to the skin on the face and left neck, shoulder & hip pain. BP initially was 182/98 which is elevated for me. Felt disoriented & very unwell. Over the next few days, low BP was noted @90/62, pulse 58. This occurred intermittently.
71 2021-02-07 oxygen saturation decreased feels like a muscle pull; Breathing was a little compromised; Oxygen saturation was down; Pain on le... Read more
feels like a muscle pull; Breathing was a little compromised; Oxygen saturation was down; Pain on left side to left breast; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730, expiry date: Mar2021), via an unspecified route of administration on 15Jan2021 10:47 at SINGLE DOSE reported in left shoulder for covid-19 immunisation. Medical history included asthma from 1971 and ongoing Diagnosed 50 years ago, Allergies from 1971 Diagnosed 50 years ago, Sarcoids from 2008 Sarcoids, Biopsy in 2008 and that is when she was diagnosed, ongoing sinus problems, pneumonia, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There were no concomitant medications. On 18Jan2021 07:00, on Monday, she had pain from her left side to left breast, it was a sharp pain. Monday and Tuesday, she had to sleep sitting up. Her breathing was a little compromised so she went on the breathing machine at 09:30. Her oxygen saturation went down a little. Oxygen saturation was down 09:30. Her oxygen saturation was probably at 91-92%. She thought it was Pneumonia, so they did a chest x -ray and her lungs were clear. She got it through hospital because she has higher risk. She feels like now it is better. Sometimes with deep breaths, it feels like a muscle pull on an unspecified date. She does have asthma and allergies and went on the breathing machine and she knew her oxygen levels were down. She has an oximeter that she uses to check it at home. She did not know the name of the medication she uses on the breathing machine. Today, she did not take a breathing treatment but her oximeter registered between 94-93. Usually she is at 95. She is at 94 right now. She did not have any pain at the injection site. She is unable to confirm if the injection was given intramuscularly. The breathing machine was the only medication she took. Relevant test: Chest X ray to rule out pneumonia on 20Jan2021 and it was negative. The outcome of the events Pain on left side to left breast and Breathing was a little compromised was recovering, not recovered for the event Oxygen saturation was down, while unknown for the event "feels like a muscle pull".
71 2021-02-08 hypertension Dr. received an urgent request to call a local Justice of the peace regarding one of her patients wh... Read more
Dr. received an urgent request to call a local Justice of the peace regarding one of her patients who was found dead in her home today. At this time no foul play is suspected. Dr. said the patient was relatively healthy with no major issues other than some hypertension
71 2021-02-08 chest pain Had bad headaches, muscle pain, SOB, feels hot inside the body and then it goes away, had chest and ... Read more
Had bad headaches, muscle pain, SOB, feels hot inside the body and then it goes away, had chest and arm pain
71 2021-02-08 palpitations, chest discomfort, hypertension Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is h... Read more
Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is high for her; Felt heart palpitations and pressure in her chest; Felt heart palpitations and pressure in her chest; Facial flushing, redness; Facial flushing, redness; Lips swollen and numb; Lips swollen and numb; Left arm stiffness; This is a spontaneous report from a contactable consumer reported for self. This 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 12:30 on Arm left at single dose (lot number: EL8982) for Protection from COVID. Medical history included diabetes, slightly elevated blood pressure, taking drops under her tongue for her 21 environmental allergies, clarified product as sublingual immunotherapy, had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with "met." And allergy to antibiotic. Concomitant drug included Sublingual immunotherapy, metformin at 500 mg and cetirizine hydrochloride (ZYRTEC). Past drug history included had Drug hypersensitivity to Neurontin, Detrol, Sulfur, and Neuropherntin. The patient experienced facial flushing, redness, and her lips felt like she had a Novocain shot on 22Jan2021. Her lips are still kind of numb. Can't feel her lips when she bites down on them. Believes reaction was fairly immediate. Sitting there for 15-20 min. Could feel a little facial flushing. Went home because (name withheld) is 45 minutes away from her house. By the time she got home was very flushed. Lips were getting more swollen and numb on 22Jan2021. Had an Epinephrine injection UPS Auto injector 0.3 mg, NDC: 49502 10201,Lot: 9FM783, Exp: Jun2021, Dose: injected one time in the middle of her right thigh and used it. Went to the ER. Had blood work and an EKG done. Was kept for five hours in ER. Had a chest x-ray. Blood pressure was 183 over something, which is high for her on 22Jan2021 that is controlled with medication. Experienced Hands shaking and looked like she has Parkinson's on 22Jan2021. Only lasted for a short time. Put on Prednisone for five days and told to see primary physician. Can't get into primary physician until Wednesday. Felt heart palpitations and pressure in her chest. Can't separate if it was the COVID-19 Vaccine or her nerves. She experienced Left arm stiffness on 22Jan2021. AEs require a visit to ER, was discharged from ER. Lab data on 22Jan2021 included Two sets of blood work separated by 3-4 hours: Unknown Results, Chest X-ray: Unknown Results, EKG: normal; on unknown date had a colonoscopy the day before the COVID-19 Vaccine: Unknown Results; Treatments were received for the events. Outcome of the events was unknown.
71 2021-02-08 heart rate irregular I am having a feeling like I am in shock; I woke up last night not feeling right and this; Irregular... Read more
I am having a feeling like I am in shock; I woke up last night not feeling right and this; Irregular heartbeat/Pulse 112/Pulse 108/went to 112; checked blood pressure, the lower number was high, upper number lower than what it usually is/130/96/then 110/78; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL3247) via an unspecified route of administration on 21Jan2021 10:00 am at single dose in left arm for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medication included ongoing atenolol for high blood pressure, ongoing amlodipine for high blood pressure, ongoing lisinopril for high blood pressure. The patient received the Pfizer COVID-19 vaccine at 10 am yesterday, her symptoms started last night and came on suddenly. She went and checked her blood pressure on 25Jan2021, the lower number was high, upper number lower than what it usually is, it was exactly: 130/96, Pulse 112, then 110/78 Pulse 108, after taking her medication. Her pulse went to 112, it does that when it gets irregular, it did get better after blood pressure medication atenolol. She woke up last night not feeling right and this morning, she was having a feeling like she was in shock. She developed an irregular heart beat last night on 25Jan2021. It is still bothering her. She had her first shot on Thursday of this past week. She is unsure if this is a side effect. Received the vaccine on 21Jan2021. She says it feels like it is right before you pass out. No treatment received. She is supposed to take blood pressure medication but she is being cautious right now. Her blood pressure medications are: Atenolol, Amlodipine, Lisinopril. She did not take them this morning, all have taken for years. Event outcome of irregular heartbeat was not recovered, while for others was unknown.
71 2021-02-08 blood pressure increased, nosebleed On 02/06/2021 at 12:10 pm at church . I start having severe nose bleeding for almost 1hr. Went to... Read more
On 02/06/2021 at 12:10 pm at church . I start having severe nose bleeding for almost 1hr. Went to ER. By ambulance .. My blood pressure was 178/93. Then started having severe nose bleeding 02/07/2021at 11pm . Bleeding was very severe it less about 45 min . When I pressure my nose blood pour out both eyes and mouth . Bp was 168/90 I take very small dose of bp meds . Atacand 8 mg for last 13 years . It has been control last 13 years. I weight 107 pound . I walk 4 mile 1 1/2 hrs a day and yoga at night for 1 hr. Eat very healthy diet . All this severe nose bleeding started 3 days after Covid Vaccine received . I am lucky this bleeding didn?t happen in my brain .it?s very scarily.
71 2021-02-08 chest pain Patient experienced chest pains post vaccination. EMS was on site and transported patient to the hos... Read more
Patient experienced chest pains post vaccination. EMS was on site and transported patient to the hospital. Patient was taken to ? Hospital, per patients request.
71 2021-02-10 palpitations, blood pressure increased, atrial fibrillation Afib; Felt dizzy; heart racing; elevated BP; This is a spontaneous report from a contactable pharmac... Read more
Afib; Felt dizzy; heart racing; elevated BP; This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration at the right arm on 23Jan2021 at 13:30 (01:30 PM) at single dose for COVID-19 immunization, administered in workplace clinic. The patient is not pregnant. The patient's medical history included atrial fibrillation (Afib), hypertension, thyroid cancer, and lymphoma. It was unknown if the patient has known allergies. Concomitant medications (other medications in two weeks) included multiple prescription medications (unspecified). It was unknown if the patient had other vaccines in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient felt dizzy, heart racing, elevated BP (blood pressure), and Afib on 23Jan2021 at 13:30 (01:30 PM), described as: Felt dizzy and "heart racing", elevated BP (blood pressure) noted with Afib on monitor. Patient felt symptoms at 15 minutes with periods of Afib and normal sinus on the monitor. Vitals and ongoing monitoring taken. The patient verbalized history of chronic Afib. No other symptoms and no distress noted otherwise. The patient and her family declined ER treatment or further medical evaluation. The patient did not receive treatment for the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was recovered on Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
71 2021-02-10 chest discomfort After getting vaccine and driving home I had tingling in right leg from calf to toes, lasted about 2... Read more
After getting vaccine and driving home I had tingling in right leg from calf to toes, lasted about 20 minutes. From 7:00 thru 9:00pm had tightness in middle of chest and upper back discomfort. Next morning no reactions other than sore injection site.
71 2021-02-10 palpitations Headache Heart palpitations Nausea Dry Heaving Chills Diarrhea Lack of appetite Sleep interrupti... Read more
Headache Heart palpitations Nausea Dry Heaving Chills Diarrhea Lack of appetite Sleep interruption
71 2021-02-10 lightheadedness, hypertension, palpitations Her head felt funny dizzy, like full headed like she was going to pass out/like she could pass out; ... Read more
Her head felt funny dizzy, like full headed like she was going to pass out/like she could pass out; Dizzy; Her head felt funny dizzy, like full headed like she was going to pass out; Head became funny, and her body felt funny; Her blood pressure was 160/("something, I don't remember, but it was high"); Her heart was going to pound out of her chest "blow right out of my chest."/her pulse was in the 90s at that point; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 27Jan2021 10:30 at single dose for covid-19 immunization. Medical history included she had Grave's disease in the past and her thyroid was irradiated, hypotension, arthritis, stress, macular degeneration, glaucoma, hypertension, Blood cholesterol abnormal, Dry eyes, other medication allergies. Concomitant medications included vitamin b complex (B COMPLEX) for Stress, liothyronine sodium (CYTOMEL) for Hypotension, ezetimibe for cholesterol, fish oil for Macular degeneration and Glaucoma, hydrocodone bitartrate/paracetamol (LORCET) for Arthritis, xantofyl/zeaxanthin (LUTEIN ZEAXANTHIN) for Macular degeneration and Glaucoma, levothyroxine sodium (SYNTHROID) for Hypotension, carmellose sodium (THERATEARS) for Dry eyes, triamterene for high blood pressure, tocopherol (VITAMIN E) as something good to take, latanoprostene bunod (VYZULTA) for Glaucoma, and Multivitamins took once daily by mouth took for 15 or 20 years as feel she should take, all of them were ongoing. The past drug history included before starting latanoprostene bunod (VYZULTA) for Glaucoma, she was on other products that she reacted to including 'Timerol'; 'Represso'; and Bimatoprost (LUMIGAN). During the 15 minute waiting period after administration, patient stated at around 11 minutes she felt as if her heart was going to pound out of her chest "blow right out of my chest", she became dizzy, head became funny, and her body felt funny. Patient stated that they called for the paramedics in which they ran an electrocardiogram (EKG), her pulse was in the 90s at that point, and her blood pressure was 160/("something, but it was high"). Patient stated that they had her wait an additional 20 minutes or so and then she left, but it was about an hour and a half before these effects went away. Patient asked if she should receive the second dose of the vaccine. Heart rate was back down to 90 bpm and her EKG was okay. They told her to wait for 15 minutes in her car; she was sitting talking and she had a couple of minutes left on her wait time when suddenly and she grabbed her chest and her heart, her head felt funny dizzy, like full headed like she was going to pass out/like she could pass out. She put her head on the steering wheel and her friend signaled the paramedics to the car. The paramedics examined her, took her blood pressure and it was a little high 160 over something. The feeling went away and she sat there for about 20 minutes until she was able to drive. One hour to one and one-half later she felt normal. The outcome of the events was recovered on 27Jan2021.
71 2021-02-11 blood pressure increased DIZZINESS, NAUSEAS, INCREASED IN BLOOD PRESSURE, DECREASE IN BLOOD SUGAR
71 2021-02-15 oxygen saturation decreased Systemic: Flushed / Sweating-Mild, Systemic: O2 levels dropped. No flushing/sweating but system woul... Read more
Systemic: Flushed / Sweating-Mild, Systemic: O2 levels dropped. No flushing/sweating but system would not let me uncheck section-Medium, Additional Details: her oxygen saturations were 93-96% on room air all of January, she received her first vaccine January 20, 2021. She received her second vaccine February 3, 2021. Her sats for February were 92-94% up until the sixth of February when she noticeably dropped to 91% on room air, she started being supplemented occasionally with oxygen on the 8th. She continues to be supplemented with oxygen. Not sure if related to vaccine or not
71 2021-02-16 hypotension, heart rate decreased Patient described blurry vision, diaphoretic, low heart rate of 60, hypotensive 90/60.
71 2021-02-17 deep vein blood clot, pulmonary embolism, blood clot, low blood oxigenation 1 week after receiving first dose of Pfizer COVID vaccine (received 1/26/2021), develop worsening sh... Read more
1 week after receiving first dose of Pfizer COVID vaccine (received 1/26/2021), develop worsening shortness of breath. Presented to ER on 2/4/2021. Found to have submassive pulmonary embolism with evidence of right heart strain, US showed left lower extremity DVT. Also found to have descending aortic thrombus with extensive clot burden. Was hypoxic 89% on room air.
71 2021-02-17 loss of consciousness passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chil... Read more
passed out; passed out when went into bathroom at 5 am, cut chin when fell; dehydrated; sweats; chills-shivers; Bad headache; Dizziness; Couldn't sleep; Neuropathy pain in hip/groin; This is a spontaneous report from a contactable consumer reporting for herself. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809 and expiry date unknown) on 05Feb2021 08:30 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included known allergies to statins. The patient had received first dose of BNT162B2 (lot number EL3248) on 15Jan2021 16:00 for COVID-19 immunization (vaccine location=Left arm). The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included gabapentin (GABAPENTIN), fish oil (FISH OIL), zinc (ZINC), cyanocobalamin (VITAMIN B 12), iron (IRON). No other vaccine received in four weeks. The patient experienced adverse events from 05Feb2021 at 20:30. She experienced chills-shivers, had bad head ache, dizziness, couldn't sleep, intense neuropathy pain in hip/groin when got out of bed and then passed out when went into bathroom at 5 am (06Feb2021), cut chin when fell. She felt dehydrated. Cold marble floor felt good as she had sweats, so she just layed there awhile. Her husband came to her rescue with water and cold compress for her head. She received lots of liquids and rest. She had good night's sleep on 06Feb2021. The outcome of the events was reported on 07Feb2021 as recovered.
71 2021-02-18 loss of consciousness Dizziness (severe), cannot sit up or stand up without passing out, convulsing (shaking) and severe n... Read more
Dizziness (severe), cannot sit up or stand up without passing out, convulsing (shaking) and severe nausea.
71 2021-02-18 chest discomfort Extremely cold, migraines, nausea, tightness in chest, face rash, joint pains, extremely tired
71 2021-02-18 hypertension Hands turned bright red. Went to Emergency room Blood pressure was high.
71 2021-02-18 blood pressure increased, hypotension, pulse abnormal Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; re... Read more
Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
71 2021-02-22 nosebleed Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating h... Read more
Starting 16 hrs. Post vaccine; sniffles, fever 102 F. , mild bloody nose, arm pain, excruciating head ache and facial pain not relieved by #2 50mg Ultram every 4 to 5 hrs, lethargy, chapped lips and cold sore. February 23rd most symptoms gone except lethargy and cold sore.
71 2021-02-22 chest discomfort This patient started to feel lightheaded and had a dry mouth approximately 5 minutes after receiving... Read more
This patient started to feel lightheaded and had a dry mouth approximately 5 minutes after receiving her Pfizer mRNA COVID-19 vaccine. Over the next 20 to 25 minutes she progressed to having a sensation of tongue swelling, then difficulty swallowing, then chest tightness. Her vital signs were stable throughout the observation period (blood pressure 144/74 and 150/70, pulse in the high 80s to low 90s, and oxygen saturation 96-98% on room air) and she was able to speak in full sentences without any respiratory distress. Her lungs were clear and she had no stridor. She never had any pruritic symptoms or rash/hives. Because of the progressive nature of her symptoms, however, I felt she needed emergency room evaluation for observation. We never administered any medication while at the vaccine clinic including epinephrine or Benadryl. After approximately 25 minutes, 911 was called and she was transported by ambulance to the emergency room in stable condition.
71 2021-02-23 chest pain, chest discomfort Chest pain and pressure; Chest pain and pressure; Numbness on left jaw, arm and hand; This is a spon... Read more
Chest pain and pressure; Chest pain and pressure; Numbness on left jaw, arm and hand; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in right arm on 23Jan2021 13:45 at single dose for COVID-19 immunisation in facility type other. The patient's medical history included asthma, unspecified auto immune, sickle cell trait, reflux. The patient have allergies to medications, food, or other products. Concomitant medications included nifedipine (CELEBRATE) at 200 mg, mirtazapine at 7.5 mg, vitamin b12, ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 23Jan2021 04:00 AM, the patient experienced chest pain and pressure, numbness on left jaw, arm and hand. The adverse events result in emergency room/department or urgent care. The events were considered as non-serious by the other healthcare professional. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
71 2021-02-23 chest pain Experienced Chest pain and dizziness shortly after the first vaccine shot, but did not last too long... Read more
Experienced Chest pain and dizziness shortly after the first vaccine shot, but did not last too long. Is this a normal side effect of the vaccine shot?
71 2021-02-23 heart rate increased Triggered rapid heart beat that started morning after the dosealong with other more expected sx, la... Read more
Triggered rapid heart beat that started morning after the dosealong with other more expected sx, lasted 16 hours at rate of 100-130 and was still occurring when I went to bed. Had stopped by morning when I awoke. Extra flecainide didn?t interrupt it at all. A 20 mg dose of propranolol brought rate down to 99 just before bedtime.
71 2021-02-23 blood pressure increased, palpitations approx. 15 minutes after vaccination client reported heart palpitations and feeling light headed. C... Read more
approx. 15 minutes after vaccination client reported heart palpitations and feeling light headed. Client was assessed by EMS and found to have elevated blood pressure and pulse. 1st vital signs: BP-180/100, P-130, R-18 2nd vital signs: Bp-160/90, P-118, R-18 After 30 minutes of observation client continued to report feeling light headed. Client chose to go to urgent care to be assessed by a physician. Client transported to urgent care by her husband.
71 2021-02-24 low blood oxigenation 1/14/21 - Resident complained of SOB. SPO2 66% on RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% ... Read more
1/14/21 - Resident complained of SOB. SPO2 66% on RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% Binax test revealed (+) COVID results. Resident transferred to COVID wing. Family (HCP) updated and declined transfer to hospital Resident continued with fever, hypoxia and lethargy. Family elected CMO and Hospice notified. Resident died on 1/16/2021 @ 930AM.
71 2021-02-24 hypertension, chest pain Blood pressure roller coaster over 3 days: highest 148/84 down to lowest 105/85; chills, pain in upp... Read more
Blood pressure roller coaster over 3 days: highest 148/84 down to lowest 105/85; chills, pain in upper left quadrant chest on 3rd day, vision issue and pressure behind left eye after 5 minutes--pressure lasted for 3 days with different levels of pressure; chills, dripping nose on day 1, and itchiness on both arms especially around elbows--has continued
71 2021-02-24 hypotension, fibrin d dimer increased, cardio-respiratory arrest, blood glucose increased Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD, hypertension and an... Read more
Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD, hypertension and anxiety and depression who presented on 2/6/2021 for evaluation of shortness of breath. Patient presented to our emergency room yesterday morning from local nursing facility rehab nursing staff reported that she had had a increased shortness of breath for the last 3 days she has been diagnosed with COVID-19 on 2-2-2021. Patient has also received both COVID-19 vaccines. Patient presented to the emergency room with labored respirations conscious awake and was on a non-rebreather at 15 L. upon arrival to our emergency room patient's temperature 101.6°, pulse 169, respirations 40 to blood pressure 142/91 and oxygen saturation 100% on 15 L non-rebreather. Patient received a chest x-ray that showed chronic emphysema and fibrotic changes in the lung no acute processes identified. Patient's white count 12.8, glucose 197, creatinine 1.2, lactic acid 4.6, cardiac enzymes negative, D-dimer 1180, patient has urine culture pending. Patient has received about 3 L normal saline boluses patient was having hypotension 86/52. Patient also received IV acetaminophen a 1000 mg IV in the emergency room along with Decadron 10 mg IV piggyback. Patient was admitted acute care for the need of IV fluids and IV antibiotics for COVID-19 and sepsis 2/12 admit Brief history and initial physical exam: Patient is a 71 year old long-term resident of Rehab and Healthcare. Unfortunately, she contracted coronavirus (COVID-19) at the nursing home. Her respiratory status started to decompensate and so she was brought into the hospital. Initial workup showed significant bilateral pleural effusions and ground-glass opacity of both lungs. She had a significant supplemental oxygen requirement. She was admitted for further evaluation and treatment. Hospital course: The patient was admitted and started on IV Remdesivir. She was given IV Decadron. She was given immune support vitamins. Despite this, her sepsis worsened. When it became apparent that the patient was not going to recover, her daughter did make her comfort care only and hospice was consulted. The patient was found to be appropriate for general inpatient hospice and was made comfort care. Her requirement for morphine and Ativan did slowly rise. Eventually, the patient did succumb to her respiratory failure. Time of death was called at 10:00 p.m. on February 15, 2021 Discharge Condition: expired. Presume cause of death with cardiopulmonary arrest secondary to acute respiratory failure secondary to coronavirus (COVID-19) pneumonia Disposition: Deceased
71 2021-02-24 hypertension Within 15-minutes of vaccination, the patient reported feeling flushed with tingling in their finger... Read more
Within 15-minutes of vaccination, the patient reported feeling flushed with tingling in their fingertips. Denied CP, SOB, or difficulty swallowing. EMS evaluated patient on-site. Patient was hypertensive (172/92) with all other vitals WNL. Physical exam was unremarkable. Patient refused transport to ED for further evaluation.
71 2021-02-25 palpitations, hypertension AFTER 10 MINUTES OF VACCINATION DEVELOPED PALPITATIONS, SOB AND HIGH BLOOD PRESSURE BP 215/90 TREATE... Read more
AFTER 10 MINUTES OF VACCINATION DEVELOPED PALPITATIONS, SOB AND HIGH BLOOD PRESSURE BP 215/90 TREATED WITH VASOTEC 2.5 MG IV X 1, AND PUT ON CARDIAC MONITOR BY DR. AND IMPROVED
71 2021-02-25 heart rate increased, lightheadedness, loss of consciousness, chest discomfort My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel we... Read more
My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel well; Nauseous; I got cold; Sick; was very hot and so hot; was round up/she was feeling she would faint; waves of feeling like i would pass out; it was just being very hot, then being cold; Blood drained from my head, I just knew I was going to pass out; I took 0.2 rather than the 0.3ml of the first dose; very fast heart rate intermediately for many day; squeezing of chest; muscle hurting/Pain in my body in every muscles, my fingers, my hands, my calves, my feet, my back, neck, everything; digestive disorders; feeling gassy, uneasy; stomach abdomen was just tight; abdominal issue; feeling gassy, uneasy; stomach abdomen was just tight; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: E18982), on 21Jan2021 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient reported that based on her history of reactions to medications, the nurses giving injections "decided 0.2ml instead of 0.3ml", which is what they gave, so she got 0.2 that is two-third of the shot. The 2nd shot was for 8'oclock on 11Feb2021. She is very sensitive to shots, vaccines, and to all medications and injections and things like that. She has sensitives thanks to two concussions she had in her life. She never was before that she had two concussions. Second one had a crazy man hit her after that just noticed that just have reactions not adverse or dying but definitely take rest of everything. So she take less of a shot, like a dental shot or cortisone shot, which she had taken in the past. If she has dental shot she cannot take Novocain, had to take Carbocaine or Marcaine and they give her half. Also she had been taking cortisone shot for shoulder for rotator cuff injury. They also have to give her less. Or flu shot: she takes half one week and come back for the other half the next week. Just have reactions. She told to when arrive for medication and did have one anaphylactic reaction but that was to cat skin dye, was told to this two nurses who was administering the vaccine and said to them she was really afraid to take. It is just too much for her. She knows her body. She is sure have reaction but is really afraid and don't know what is the first one will do to her. They just did two nurses and she decided that she will be taking 0.2 instead of 0.3ml which is what they gave. She got 0.2 so that two third of the shot and waited the half an hour, a nurse watched her card and 7 other cards. She did not have the anaphylactic reaction. She went home. Her arm hurt and started to get little tired. The events started the day that she got the shot. Like about 3 or 4 hours later. It is just few hours later she couldn't watch TV so went to laid down and an hour later she woke-up. She walked to her kitchen and blood drained from her head, she just knew she was going to pass out. Her stomach suddenly did not feel well. She tried to get back her bed but she was round up and as far as the bathroom. She got very nauseous, she laid down on bathroom floor. She thought she was sick but didn't round up having to use toilet of few times. Although while she was feeling she would faint. She was very hot and so hot. While lie down, she couldn't even pulling off her pajamas. So when she got cold so she was pulling a towel down and stop and she laid to for two hours, she finally got to her bed. It was a terrible experience. Next day she drank water and had potatoes prepared and went up eating back to later baked potatoes. Next day luckily she did not have repeat of the nausea. She didn't have that anymore of. She did have abdominal issue just not diarrhea or anything but just not feeling well, feeling gassy, so uneasy. This all lasted, that part lasted for 7 days. What concerned her was especially beside first day it was few days she got off again. She was just feel blood drain but not this first time she laid on floor. She couldn't sit on chair to watch TV for about 3 days. She mostly laid on bed but she would get very hot and then very cold during the day. She would get very fast heart beat not continue but really fast like heart was pounding her chest. She felt like someone has their hand inside her body squeezing her chest. She got afraid but didn't want to go hospital. She didn't think she was sick enough. She was concerned. So that was happened and this last was for about 7 days. Then the squeezing of chest part went away. She doesn't want to wind-up on the floor feeling that sick again, she felt so sick it felt like food poisoning. After that, it was just being very hot, then being cold, the fast heart rate, every muscle hurting. Those were the main things that continued for a week. And digestive disorders. It all lasted for about 13 days. She was concerned she had a very fast heart rate intermediately for many days, for about a week. And that's considered an adverse reaction and also she was getting waves of feeling like she would pass out, everything would drain from her head. She experienced stomach ache, feeling hot then cold. She wants to do precautions before taking the second dose on 11Feb2021. She did take may be 3 days later two Tylenol but didn't take anything (clarification requested). She didn't even take vitamins during that time. She was afraid to take anything so she did not. At the same time also there was pain in her body in every muscles, fingers, hands, calves, feet, back, neck, everything. Her stomach abdomen was just tight. She was concerned that last for few days. In last few days she started feel herself and now she is going again tomorrow. So that how she reacted. She doesn't know how much of this shot she told them she could tolerate because everybody is saying second shot will give you more reactions. All she can take this more than that because that was lot. She wants to be herself, don't want laying on floor, don't want to have 105 temperature or anything. The patient was asking if she should take another 0.2ml another two-third of the shot. She just asked them for half that is 0.15 would that be a big difference. She needed to know by 8 o'clock tomorrow. I might be in a queue to get it. She stated: 'So, that's my concern. I'm all alone, I'm a senior, I have no family. I lost my mother to covid. I know I need this vaccine, but I just, I cant get that sick and I'm so afraid I'll wind up with a 105 something, fainting away and no one knowing'. She was asking if reactions after the 2nd dose are worse than the 1st dose, if she didn't have anaphylaxis after 1st one, she shouldn't have it a 2nd time, right. She said, "1st half of flu shot, I get sick, then the 2nd half nothing". She also asked if she can take medications after the vaccine, like Tylenol, or irritable bowel syndrome (IBS) medication she takes as needed. The events resolved, but the patient reported it took her like 13 days before she felt better.
71 2021-02-25 pulse abnormal, body temperature decreased On the evening of 2/23/221 at 9:00 pm, resident reported feeling SOB, BP 80/44, Pulse 53, O2Sat 95% ... Read more
On the evening of 2/23/221 at 9:00 pm, resident reported feeling SOB, BP 80/44, Pulse 53, O2Sat 95% on 3L oxygen, hands cold, pulse weak. Temp 92.5F MD notified. EMS activated. EMS arrival and HR 20. Family refused transport to ER. Resident expired at 2:40 am on 2/24/21 Meds continued: duloextine, VITd2,hydralazine, synthroid, lisinopril, mag ox, folplex, pantoprazole, potassium chloride, ellipta, ensure, hydrocortisone cream, boost, deprox, xanax, morphine, lorazepam, tylenol, albuterol inhlation, ventolin inh.
71 2021-02-26 fast heart rate Tachycardia- cleared by medics
71 2021-02-26 blood pressure increased pt complained of nausea and dizziness 5 minutes post injection. Pt with elevated blood pressure 188... Read more
pt complained of nausea and dizziness 5 minutes post injection. Pt with elevated blood pressure 188/88 decreased mentation
71 2021-02-28 pulmonary embolism Patient received her second dose of the Pfizer vaccine today at 1330, she waited the required 15 min... Read more
Patient received her second dose of the Pfizer vaccine today at 1330, she waited the required 15 minute observation time, was feeling fine and left. She returned to the vaccine clinic around 1415 reporting that she was having trouble breathing. Security called the charge nurses and alerted them that a patient needed assistance. Writer came out to patient who was seated in her car. We assessed patient who was visibly having difficulty breathing and was unable to respond to questions without difficulty breathing. Emergency medication box was opened and epinephrine was prepped. We assessed patients allergies and recent medications taken. Patient denied hx of breathing problems or anxiety. Pt denied chest pain. Per protocol for potential allergic reaction, 0.3ml of epi was given at approximately 1426 via IM injection in the pt's left arm. ED triage nurse was called and asked to come assist. Two ED technicians with stretcher arrived and with writer accompanying them transported pt to ED.
71 2021-02-28 hypertension Weakness, dizziness, numbness in face, hypertension-evaluated by EMS and refused transportation.
71 2021-02-28 hypertension Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fev... Read more
Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fever (did not exceed 100 degrees). Underarm pain, enlarged lymph node began within 2 days post 2nd vaccine. ( Friday-Sat. Feb. 26-27) Within four days (Sunday Feb. 28) redness, swelling, pain and itching began in upper arm. ....neck pain reduced. By Monday, March 1, I contacted my family practice clinic and received a video consult with Dr.
71 2021-02-28 blood glucose increased really high blood sugar, some mornings over 300 mg; This is a spontaneous report from a contactable ... Read more
really high blood sugar, some mornings over 300 mg; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date in Feb2021 (a week ago) as a single dose for COVID-19 vaccination. Medical history included ongoing diabetic from an unknown date. Concomitant medications were not reported (reported she takes 'sugar medicine' for diabetes). In Feb2021, since receiving the vaccine, the patient experienced sugar levels have been high, the first 3 or 4 days they were really high, some mornings they were over 300mg. The patient underwent lab tests which included sugar levels which showed over 300mg on an unknown date. The patient was treated for the blood sugar high with taking half of her sugar medicine. The clinical outcome of the event blood sugar increased was recovering reported as the levels were lowering a little. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
71 2021-03-01 hypertension Patient was feeling slightly dizzy after receiving her vaccine. Patient said that her vision was haz... Read more
Patient was feeling slightly dizzy after receiving her vaccine. Patient said that her vision was hazy and she was feeling slightly nauseous. Patient said that she had a history of stomach problems and indigestion. Her blood pressure was 160/101 but she did not know what it normally ran. Patient felt better after sitting for while and her vision returned to normal.
71 2021-03-01 heart rate increased patient reported numbness in her upper deltoid muscle on the side of vaccination initially. After 5 ... Read more
patient reported numbness in her upper deltoid muscle on the side of vaccination initially. After 5 minutes the patient reported feeling a little short of breath and that her heart rate felt fast. Patient remained alert and oriented throughout. Patient was given water and instructed to perform pursed lip breathing. When attempting to move patient to a private space, she reported weakness in her legs and required assistance to transfer to a wheel chair. 911 was called when patient reported trouble breathing that was not improving. Patient also reported a history of anxiety and congestive heart failure. Patient was transported to a local emergency department via ambulance for further evaluation. Patient was transported away from our clinic at 10:15am.
71 2021-03-02 cerebrovascular accident Suffered a stroke 4 days later 06Feb2021; This is a spontaneous report from a contactable consumer, ... Read more
Suffered a stroke 4 days later 06Feb2021; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 02Feb2021 at 14:45 (at the age of 71-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient suffered a stroke 4 days later 06Feb2021 after vaccination. The event resulted in an emergency room/department visit and hospitalization in Feb2021 for 3 days. Treatment for the event stroke included medication and therapy. The outcome of the event stroke was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
71 2021-03-02 heart flutter, heart rate increased around 3pm fluttering sensation in chest area (mid section) upon taking pulse it was a strong bea... Read more
around 3pm fluttering sensation in chest area (mid section) upon taking pulse it was a strong beat, counted three beats and stopped ,again three beats and stop. Next day pulse was fine just noticed I would take in frequent deep breaths. Blood pressure was normal.
71 2021-03-02 hypertension pruritis, transient HTN 173/94 Given Benadryl 25mg IM x 1 Send to ED for further observation
71 2021-03-03 heart rate increased Rapid, strong heartbeats felt in neck and head woke me at approx 4:30 a.m. Blood pressure was 185/10... Read more
Rapid, strong heartbeats felt in neck and head woke me at approx 4:30 a.m. Blood pressure was 185/102. Took BP meds (.5 mg Ramipril and 25 mg hydrochlorothiazide). Waited 15 minutes and BP was 167/101. Waited another 15 minutes and BP was 149/91. Saw doctors PA in the afternoon, BP was 162/81. PA administered EKG, blood work, and spent a significant amount of time listening to heart, lungs and carotid arteries. Everything was in normal range except sugars, but an A1C test was normal. PA said to take an extra Ramipril at night and track BP at home for 7 days. BP went down each day and on 2/26 was in normal range. However, after 7 days, she said to permanently stay on the evening addition of Ramipril.
71 2021-03-04 blood pressure increased Pt. in observation was feeling tingling of arm, paramedics assessed blood pressure was high 174/80. ... Read more
Pt. in observation was feeling tingling of arm, paramedics assessed blood pressure was high 174/80. Once symptoms subsided paramedics release pt. to leave.
71 2021-03-06 blood pressure increased Patient was anxious, with elevated BP 150/108 (HR 117). Final BP 143/82 (pulse 78).
71 2021-03-07 heart flutter For 2 days after vaccine occasionally felt dizzy with fluttering heart. On and off. Then subsided A ... Read more
For 2 days after vaccine occasionally felt dizzy with fluttering heart. On and off. Then subsided A week after got hot flashes. Then sucsided During the second week I had an episode when I felt like fainting, Throughout the week I am increasingly tired to a level of total exhaustion and bewilderment. I have extreme reservations about taking the second shot as I never felt so extremely exhausted
71 2021-03-07 heart rate increased Rash; Fast heart beat; This is a spontaneous report from a contactable consumer. A 71-year-old femal... Read more
Rash; Fast heart beat; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 20Feb2021 (at the age of 71 years old) at a single dose for covid-19 immunisation; and paracetamol (TYLENOL), via an unspecified route of administration from an unspecified date at unknown dose and frequency for an unspecified indication. Medical history included high blood pressure, rheumatoid arthritis, tinnitus, vertigo, blood cholesterol. Concomitant medications included amlodipine for high blood pressure, lovastatin for blood cholesterol, meclizine [MECLOZINE] for vertigo, dipyridamole for tinnitus, prednisone for rheumatoid arthritis, and folic acid. On 21Feb2021, the patient experienced rash (hospitalization) and fast heart beat. "If this is the reaction, I guess I shouldn't take the second dose, right? I just think that I am not going to take second dose." Both the events required emergency room visit. The patient underwent lab tests and procedures which included blood work, electrocardiogram (EKG) and x-ray and everything came back normal on 21Feb2021. Therapeutic measure was taken as a result of the rash which included hydrocortisone. The action taken in response to the events with paracetamol was unknown. Outcome of both events was recovering. Information on the batch/lot number has been requested.
71 2021-03-08 palpitations Anxious, Shaking, Jittery ,fast heart beat. ill at ease.
71 2021-03-08 palpitations Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my ... Read more
Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my torso; feeling of muscle heaviness that I almost felt paralyzed; extreme body ache; chills; I had a bad headache; stinging on both sides of my head and on hands and feet; was very lethargic; arm became real sore and was painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiry date not reported), via an unspecified route of administration on the left arm on 27Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included mild lupus, post concussion syndrome (PPCs) and allergies: sulfur (very sensitive to large doses) from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole magnesium (NEXIUM), tramadol, alprazolam and acetylsalicylic acid (ALKA SELTZER). The patient reported that after just a few hours on 27Jan2021, their arm became real sore and was painful to use until next morning, was sore for 2 days. Hurt after much normal use. Woke up on the morning of 28Jan2021 (3 am) with chills, extreme body ache and feeling of muscle heaviness that they almost felt paralyzed. They could still move. They had a bad headache and stinging on both sides of their head and on hands and feet. They took aspirin and went back to sleep. When they got up they felt some better, but did not feel well and was very lethargic. That night they took another aspirin before bed. On the morning of 29Jan2021 (second day ) they again woke up at 3 AM to extreme body ache, the same heavy paralyzing feeling, but this time their lower back felt really heavy and there was a pounding sensation up and down their torso. They repeated the aspirin dose and went back to bed but did not sleep anymore that day. They did feel some better but still very lethargic. Next day better, but took 5 days to feel some normal w/o fatigue. The patient is very sensitive now to regular meds. Therapeutic measures were taken which included aspirin. The patient was recovering from feeling of muscle heaviness that I almost felt paralyzed, extreme body ache, chills, headache, stinging on both sides of my head and on hands and feet, lethargy recovered from arm became real sore and was painful on an unspecified date, while the outcome of the other events was unknown. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since vaccination.
71 2021-03-10 hypotension Progress Notes Date: 3/8/2021 ... Read more
Progress Notes Date: 3/8/2021 Subjective Patient is a 71 y.o. female who was seen at the clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied difficulty breathing, difficulty swallowing, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and respiratory distress. PMH: htn, hld, eczema, hypothyroidism, prediabetes ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness ("lightheaded") Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives and itching of skin Previous Reactions: none Objective Vitals Vitals: 03/08/21 0929 03/08/21 0937 03/08/21 0950 BP: (!) 153/53 (!) 154/60 (!) 153/54 BP Location: Left arm Patient Position: Sitting Pulse: 58 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is well-developed. She is not diaphoretic. Comments: Appeared to not feel well upon arrival. After water and snacks, improved. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Lightheadedness. Pt observed in the medical bay for approx 20 minutes. She was able to stand from wheelchair w/o lightheadedness/dizziness. She states she feels much better and is ready to go home. Pt provided handwritten instructions on monitoring her bp at home and when to follow up with pcp. She was taken out to the front accompanied by her husband by RN. She and husband both voice appreciation of today's care. 3/8/2021 9:36 AM
71 2021-03-10 heart rate increased beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; fa... Read more
beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; face lips; felt paralyzed/Felt like I couldn't move it like paralyzed a little bit; whole left side of body started going numb/Left side was numb around 7 or 8 that night/all left side was numb; pains in all of her face; pain and soreness in arm/arm was painful; tachycard, high heart rate; very tired, sleepy; very tired, sleepy; headache, heavy in her head; pain in both ears; This is a spontaneous report from a contactable consumer (patient). This 71-years-Old female patient received the first dose of (Pfizer Biontech Covid 19 Vaccine, Lot No. EN6198) intramuscularly at single dose on 23Feb2021 for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. Past dug included flu vaccine in Sep2020. The patient received her first dose of Covid 19 vaccine on 23Feb2021 at 3:30 in the afternoon. She came home and felt, not bad at any time but more or less towards 6:00 or 7:00 at night she started feeling bad. Her whole left side of body started going numb around 7 or 8 that night. Her arm was painful, face lips and all left side was numb. Felt like she couldn't move it like paralyzed a little bit. Clarified as whole left side, even her leg, her feet everything on that left side. She started feeling pains in bones of head, especially her face, clarified all of her face and her left side was numb even her lips on the left side were numb. Her tongue was a little numb. She had muscle and joint pain. The pain, of course, in the arm, but that was normal. Clarified pain in the arm as the injection site. She didn't feel any swell there. She did not take medication for anything. She used a lotion. The lotion was trividol aloe vera arnica caleudula and helped to relive the pain. The arm was still a little painful but it's not bad but that feeling made her tachycard, clarified as high heart rate, feeling like boom boom boom, but she did not have any shortness of breath. The high heart rate was gone the same day. She had no fever or chills. She felt very tired and slept for about 10 hours but during the sleepy she started feeling a headache she couldn't get up because she was so tired and she felt pain in both ears. She had not been to the doctor in a while. She was still old fashioned so she carries everything in a little telephone book. While trying to read information caller states she had to change her eyes. She still felt numbness in left side of left leg but she thought it might be because she had not been exercising. When she was waking up around 9am in the morning, it was yesterday that she felt better in regards to the paralyzed feeling. When pains in her face came she felt and she thought what is this? It only lasted for a little while. It was during the night. The pain and soreness in arm at injection site is still there, she did not feel any swelling, or hot at that site. She confirmed she still felt a little tired, sleepy. It's getting better. She may feel a little heavy in her head and would like to go to sleep, but she was not sleeping. She had many things to do and knew she had to be up. The headache went away and was gone on 24Feb2021. It was persisting for a while, not too hard or heavy, but it resolved by 2 or 3 in the afternoon on the 24th. In regarding to pain in ears she mentioned she no longer had. She had beeps, noise in her ears even at the time she went to bed it was better. The outcome of events paralyzed, pain in arm, tired, sleepy, was recovering, the outcome of events tachycard, pains in all of her face, pain in both ears was resovled, the outcome of other events was unknown.
71 2021-03-11 blood pressure increased 3/9/21 ER HPI Patient is a 71 y.o. female who presents with complaint of elevated blood pressure sys... Read more
3/9/21 ER HPI Patient is a 71 y.o. female who presents with complaint of elevated blood pressure systolic of over 200 since last night. Patient said that she has taken her blood pressure medications without much improvement. The elevated blood pressure is associated with frontal headache. No nausea vomiting, no dizziness, no chest pain, no cough or shortness of breath. No fever or chills
71 2021-03-11 atrial fibrillation, heart rate increased Afib episode; rapid heart beat; pain in jaw; diarrhea; headache; nausea; dizziness; This is a sponta... Read more
Afib episode; rapid heart beat; pain in jaw; diarrhea; headache; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number El266) via an unspecified route of administration in the left arm on 05Mar2021 at 09:00 (at the age of 71-year-old) at single dose for COVID-19 immunisation. Relevant medical history included atrial fibrillation, asthma, chronic obstructive pulmonary disease, high cholesterol, acid reflux disease, depression and anxiety. Concomitant medications included clonazepam, apixaban (ELIQUIS), fluoxetine, metoprolol and simvastatin. On 07Mar2021 at 14:00, the patient experienced Afib episode, rapid heart beat, pain in jaw, diarrhea, headache, nausea and dizziness; the events Afib episode and rapid heart beat were considered serious as life-threatening. The patient received corrective treatment for the reported events, which included 2 tablets of metoprolol. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. The patient recovered from the events on an unspecified date. No follow-up attempts are possible. No further information is expected.
71 2021-03-11 chest pain After first dose of vaccine, c/o chest pain, SOB, diaphoresis, BL arm pain, jaw pain. EMS was called... Read more
After first dose of vaccine, c/o chest pain, SOB, diaphoresis, BL arm pain, jaw pain. EMS was called and assumed care for transfer to hospital. Contacted patient 2 days after event and patient reports that she was feeling well. She notes that she was not actually transported to the hospital by EMS. She notes that she was evaluated in the ambulance. Since her EKG was normal, she states that she elected to be discharged home. She notes that she believes that she had an anxiety attack as she has events like this previously. She notes that she has discussed the event with her PCP. She is scheduled for 2nd vaccine on 3/20/21.
71 2021-03-11 low blood oxigenation SHORTNESS OF BREATH Respiratory distress Hypoxia Pneumonia due to COVID-19 virus Death
71 2021-03-11 low platelet count This patient developed a severe, multisystem inflammatory syndrome after covid vaccination that nece... Read more
This patient developed a severe, multisystem inflammatory syndrome after covid vaccination that necessitated hospitalization for 6 days. It involved skin (rash), liver (elevated bilirubin and asT/alt), bone marrow (leukopenia, thrombocytopenia), cns (hallucinations, visual disturbance), and musculoskeletal system (synovitis). Inflammatory markers were markedly elevated with ferritin over 1000 and CRP over 100. COVID infection was definitively excluded.
71 2021-03-11 fainting led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (... Read more
led to a fall (possible faint) that caused a head injury (bone chip above her eye).; led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); led to a fall (possible faint) that caused a head injury (bone chip above her eye); Nausea; shivers; fever; dehydration; This is a spontaneous report from a non-contactable consumer (patient) 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number and expiry date not reported) via an unspecified route of administration, on 22Feb2021 (in the age of 71-years-old) at single dose for covid-19 immunization. Medical history included chronic headaches, high cholesterol, high blood pressure and minor heart condition. Patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included candesartan, rosuvastatin, gabapentin, topiramate, amitriptyline and erenumab aooe (AIMOVIG), all from an unspecified date for an unspecified indication. It was reported that 2 days after second dose (reported as 24Feb2021), the patient experienced nausea, shivers, fever and dehydration which led to a fall (possible faint) that caused a head injury (bone chip above her eye). As a result, the patient had an ER visit and they provided her with fluids and stitches. The outcome of events was reported as 'recovering'. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
71 2021-03-13 chest pain intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy I to... Read more
intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy I took Tylenol Extra Strength tablets for the headache & muscle pain. The headaches lasted for 3 days. The muscle pain for 3 days. The vomiting occurred on the day after the shot - 1 time. I remained nauseous for the next 3 days. The chest pain has been on and off for the past 2 days. It has been mild. The lightheadedness lasted for 4 days. The lack of energy is still ongoing, but is getting better.
71 2021-03-14 heart flutter Besides sore arm, chills, and fatigue, heart flutters were felt within 2- 3 hours of injection. Hea... Read more
Besides sore arm, chills, and fatigue, heart flutters were felt within 2- 3 hours of injection. Heart felt like it was skipping a beat and was continuous the rest of the day and night. Subsided gradually over the next 2 days after injection.
71 2021-03-14 hypertension, heart rate increased, blood pressure fluctuation moderate anaphylaxis - body shaking, rapid heart beat, high and fluctuating blood pressure, immedia... Read more
moderate anaphylaxis - body shaking, rapid heart beat, high and fluctuating blood pressure, immediate dry throat and feeling of dehydration, stomach cramps followed by diarrhea about half hour after onset. Symptoms eased after 30-40 minutes so that I could get home and then diarrhea and weakness and shakiness for 3-4 hours. No epi pen administered because breathing was ok
71 2021-03-15 chest discomfort Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to conce... Read more
Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to concentrate , extreme weakness & fatigue, extreme focused joint pain, headache, coughing and difficulty breathing requiring multiple nebulizer uses every 2 hours over 2 weeks, headache. Face & body rash, . Persistent exhaustion continues requiring 2-3 hour daily naps & non Fibro brain fog continues at 3 weeks.
71 2021-03-16 blood pressure increased After waiting 30 minutes after my injection, I left the hospital and was driving home when I began t... Read more
After waiting 30 minutes after my injection, I left the hospital and was driving home when I began to feel my face tingling and swelling. This was close to 45 minutes after the injection. I was not sure what I was feeling, but had a similar reaction to the first Shingles shot so I was monitoring what I felt. I went to a walk in clinic about 2 hours after this feeling began. The swelling was on the right side of my face from a midline of my top lip to my right cheek. The doctor I saw told me to take Benadryl and gave me scripts for a Medrol Dosepak and epi pens. I took the Benadryl and got through the evening. I took Benadryl on Saturday and stopped it on Sunday. My face was still puffy, but no worse. Sunday night, my face felt worse and I took the Benadryl again. Monday morning, my face was slightly more swollen. I decided to start the Medrol Dosepak. My face was not feeling good and my throat felt like I was swallowing a boulder when I ate making me think that my throat might be closing up a bit. I decided to use the epi pen, gave myself the shot, got the shakes from the shot, and went to the emergency room as instructed on the pen. My blood pressure was very high arriving at the hospital which was from the epi pen. I was watched at the hospital, the epi pen had done it's work, and I went home 4 1/2 hours later. I have had continued puffiness in my face. I have been given Famotidine to add to the Benadryl as I had with the shingles vaccine reaction. This Wednesday after getting the shot on the previous Friday.
71 2021-03-16 heart rate increased Numbing and tingling around mouth area, lightheadedness, dizziness, slight chills sore throat, tired... Read more
Numbing and tingling around mouth area, lightheadedness, dizziness, slight chills sore throat, tiredness, slight headache, injection site swelling and redness slight fast heartbeat,Light weakness
71 2021-03-16 hypertension pt was experiencing extreme anxiety prior to vaccination today, high bp following initial dose with ... Read more
pt was experiencing extreme anxiety prior to vaccination today, high bp following initial dose with dizzy spells, pt is alert and stable, resting comfortably, pt bp returned to wnl after spending time in the observation tent, observed pt walking- pt is steady, no dizziness, pt felt comfortable to drive herself home.
71 2021-03-17 fainting, loss of consciousness Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Medium
71 2021-03-17 cardiac arrhythmia Within a week of receiving first vaccination, had long runs of skipped beats, went into a 30-40 seco... Read more
Within a week of receiving first vaccination, had long runs of skipped beats, went into a 30-40 second long continuous arrhythmia. These continued for about a week and a half all day and night long. These let up for a few days. Had the second vaccine on 3/16 and having am having PVC's again.
71 2021-03-18 blood pressure increased Extreme muscle pain and slight headache which was gone by 3/18/2021. Hurt to even turn head. Spike... Read more
Extreme muscle pain and slight headache which was gone by 3/18/2021. Hurt to even turn head. Spike in blood pressure on 3/18/2021 to 191/91. Returned to 152/71 on 3/19/2021.
71 2021-03-18 platelet count decreased Four days after the first dose of Pfizer on 2/24/2021, got blisters in mouth bleeding, bruises on th... Read more
Four days after the first dose of Pfizer on 2/24/2021, got blisters in mouth bleeding, bruises on the legs, arms, hands, and shoulder, sore legs, very weak, difficult to sleep.
71 2021-03-18 chest discomfort pt said tongue and lips felt funny - no breathing issues- some pressure in her chest- within 10 -1... Read more
pt said tongue and lips felt funny - no breathing issues- some pressure in her chest- within 10 -15 minutes of vaccine her blood pressure was 167/82 at one point but lowered to 125 /80 within 30 minutes she took 50mg of liquid benadryl she did not want to go to er since no breathing issues - she said she would go to hospital if she felt bad later
71 2021-03-19 chest discomfort While in observation area patient reported being light headed . Several minutes later she reported ... Read more
While in observation area patient reported being light headed . Several minutes later she reported tingling on tongue . I gave her a diphenhydramine 50mg injection and observed for about 7 minutes when she reported tightness in her chest . I injected epinephrine .3mg intramuscularly in the right thigh. I proceeded to call 911 for transportation to medical facility.
71 2021-03-21 chest discomfort Flushing, Excess moisture in eyes and mouth, strong metallic taste in mouth, weakness in knees, shor... Read more
Flushing, Excess moisture in eyes and mouth, strong metallic taste in mouth, weakness in knees, short vision disturbance. Symptoms subsided after an hour. Next day fluttering in chest. No trouble breathing
71 2021-03-21 cerebral haemorrhage Patient presented with frequent falls and left sided weakness with severe headaches for greater then... Read more
Patient presented with frequent falls and left sided weakness with severe headaches for greater then 24 hours.
71 2021-03-21 heart rate increased, fainting extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid ... Read more
extreme fatigue; faintness; severe headache; fever(100 degrees); nausea; shortness of breath; rapid heart beat; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6205, via an unspecified route of administration, administered in left arm on 04Mar2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure, pre-diabetic, penicillin allergies, allergies to sulfa drugs and bee stings. Concomitant medication included calcium. Historical vaccine included BNT162B2 on 11Feb2021 (lot number: EM9810) for COVID-19 immunization. On 04Mar2021, after 1 hour, the patient experienced shortness of breath and rapid heartbeat. At 12 hours, severe headache, fever (100 degrees) nausea, faintness, extreme fatigue 24 hours later, started to feel normal again 6 hours later. No treatment information was reported. The outcome of the events shortness of breath and rapid heartbeat was recovered on 04Mar2021, For events faintness, severe headache, fever (100 degrees), nausea and extreme fatigue was recovered on 05Mar2021. No follow-up attempts are possible. No further information is expected.
71 2021-03-21 blood pressure increased mild peripheral neuropathy/sensory peripheral neuropathy around her gums and lips on her left side, ... Read more
mild peripheral neuropathy/sensory peripheral neuropathy around her gums and lips on her left side, as well as tingling on 4 of the 5 fingers of her left hand; paralysis in her lips and gums all the way down to her finger tips on the side of the injection which was the left side; portion of the trigeminal nerve on the left side seemed to have been impacted; blood pressure had sky rocketed; This is a spontaneous report from a contactable physician and a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), lot no. EL9269, via an unspecified route of administration on 13Feb2021 at a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The physician asked if there were any reports of paresthesia around the gums and/or tingling in the hands and fingers. The patient received the first dose of the Pfizer COVID-19 vaccine. About 1 week after receiving the vaccine (20Feb2021), she experienced symptom complex, consistent with a mild peripheral neuropathy/sensory peripheral neuropathy around her gums and lips on her left side, as well as tingling on 4 of the 5 fingers of her left hand, She was admitted and a full workup for central disorders and vascular disorders was negative (Feb2021). But her symptoms were continuing intermittently. She had numbness of the gums. A portion of the trigeminal nerve on the left side seemed to have been impacted. Also, peri-orally on the left side. The physician asked if this symptom complex has been reported and if there were reports of these mild sensory peripheral neuropathies coming from the vaccine. The physician stated that any info on dental paresthesia or any reports of other incidents of sensory paresthesia would be very helpful. The patient also called about the COVID 19 vaccine. On 13Feb, she got the vaccine in and then one week later on the following Saturday, the date would have been 20Feb, she started having a sensation of tingling and paralysis in her lips and gums all the way down to her finger tips on the side of the injection which was the left side and that has continued. She went to see the doctor the following Monday 22Feb and not knowing what it was, she sent her to the ER she was kept overnight, she was discharged 23Feb but her symptoms persisted even through today. These sensations were happening on average 3 times per day, sometimes many more anywhere from 3 minutes to 1 hour 45 minutes then it goes away. She did not go to her primary care. She confirmed her first dose was given 13Feb and the tingling and paralysis started the 20Feb it was still ongoing at this time. It has persisted but she can't tell whether it was getting better or not because sometimes it will last 3 minutes sometimes it will last 1 hour and 45 minutes. It started to effect other parts of her so she thinks it might be getting a little bit worse. It was starting to effect other parts of her body the progression goes, it started at the tip of her tongue and gums and then shortly within 30 seconds or less than a minute it spread to her upper and lower lip only on the left side and that was how it was on her gums as well it was only on the left side then she had the tingling in her finger tips on the left hand. She specified that she experienced these sensations on the tip of her tongue, left gums, lower left lip, and into the fingers on the left hand. She would like to know if these symptoms have been reported in association with the vaccine and if so, how long she can expect them to last. She stated that yesterday, a physician called in on her behalf for more information and said he received literature from 29Jan regarding reports that included information about dental paresthesia after the vaccine. She was planning not to get the second vaccine. She was not taking medications, she was in good health she did go and was admitted in the ER, they did a work up. Her blood pressure had sky rocketed on Feb2021 and since she mentioned sensation they ruled out a stroke. On Feb2021, they did blood work, MRI and CT scan and everything was they did not find anything linking to a stroke. She spent the night in observation. She was in the ER, they did put her in the main hospital but it was for observation from the emergency room. She went in on the 22Feb and was discharged home on 23Feb. She asked where this goes from here, these symptoms were concerning to her. She did not find any incidences at least in general of reporting this, asked if there were these kinds of things being reported, she didn't know how long it was going to last or if it will get worse. The outcome of blood pressure had sky rocketed was unknown while outcome of other events was not recovered.
71 2021-03-22 heart attack, low blood oxigenation, chest pain CHEST PAIN SHORTNESS OF BREATH Respiratory distress Hypoxia Suspected COVID-19 virus infection Non-S... Read more
CHEST PAIN SHORTNESS OF BREATH Respiratory distress Hypoxia Suspected COVID-19 virus infection Non-ST elevation (NSTEMI) myocardial infarction
71 2021-03-22 hypertension Headache, muscle aches, hypertension beginning 3 days after shot lasting for 1 week after first shot... Read more
Headache, muscle aches, hypertension beginning 3 days after shot lasting for 1 week after first shot, lasted 12 dats after 2nd shot
71 2021-03-22 atrial fibrillation Patient reported that she had a episode of Afib that required hospitalization X24 hours. Pt states s... Read more
Patient reported that she had a episode of Afib that required hospitalization X24 hours. Pt states she has a hx of afib but has not had an episode in several years and has always been easily converted. This episode did not convert easily and required the patient to stay overnight at the hospital. Additional questions regarding treatment should be directed to the hospital or to the patient.
71 2021-03-23 palpitations DAY 1 - HIGH FEVER ( UNDER CONTROL WITH THE USAGE OF TYLENOL) DAY 2 - PALPITATIONS (MILD) DAY 3-DA... Read more
DAY 1 - HIGH FEVER ( UNDER CONTROL WITH THE USAGE OF TYLENOL) DAY 2 - PALPITATIONS (MILD) DAY 3-DAY 5 - PALPITATIONS DAY 6 - WOKE UP AT 3:30 AM DUE TO PALPITATIONS (AND ABNORMAL SINUS RHYTHM) WENT TO THE ER. RELEASED OH HER OWN INSISTENCE
71 2021-03-23 chest pain Patient has symptoms of chest pain that lasted for 4 hours
71 2021-03-23 fibrin d dimer increased, blood glucose increased, haemoglobin decreased, atrial fibrillation The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias... Read more
The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias, malaise. Patient related she was in her normal state of health and only started to feel poorly after she received her second COVID-19 vaccination three days earlier. She interestingly related that after her first Pfizer COVID-19 vaccination she had significant burning in her stomach that she noted but no other major symptoms and notably did not experience this severe burning in her stomach after the second dose. She denied any chest pain, current dyspnea, productive cough, sore throat, urinary symptoms, sick contacts. She has no history of C. difficile, no recent antibiotics, no recent spoiled foods, no recent travel, no history of radiation. She does have a history of GERD and has had gastritis with mild gastrointestinal bleeding in the past and undergone EGD negative for H. pylori infection. She also has undergone colonoscopies with polyps that have been removed and reported as tubular adenomas. As her hospitalization progressed, she was diagnosed with Severe Sepsis due to E. Coli bacteremia in setting of liver abscess, Cholelithiasis without acute cholecystitis, Atrial Fibrillation with rapid ventricular response, Transaminitis (which resolved). Patient was appropriately treated for these conditions. Also, her known uncontrolled diabetes was treated. Per an Infection Disease note on 3/9/21: The patient has had hx of biliary colic (self diagnosis) now with discovery of non-obstructive cholelithiasis on RUQ US it is plausible that the abscess originated from self limiting cholecystitis/cholangitis which would be consistent with recent abdominal pain exacerbated with oral intake. Difficult to state definitively any relation to COVID-19 vaccination, though may have resulted from associated dehydration. Additional COVID vaccine info (both Pfizer): first dose: 2/7/21 lot# EN 5318 second dose: 2/28/21 lot# EN6202
71 2021-03-23 chest discomfort chest pressure. Evaluated by EMS-Cleared
71 2021-03-24 blood pressure increased, pallor, chest pain, chest discomfort Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing cli... Read more
Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing client. Vitals were taken (180/90; 97% RA; hr 97. Client was given water and a fan was placed near pt. Client then began to complain of chest discomfort and burning in her throat like heartburn. She also began to feel nauseous. The dizziness began to get better. The client initially began to say she was feeling better, a couple minutes later she began to complain of chest pain/pressure. She described it as an elephant sitting on her chest. She also stated that her left shoulder began to hurt. She was also pale. Her vitals at this time were bp of 170/85; 02 of 97%; hr of 78. 911 was called at 4:10pm and arrived at 4:15pm. Chest pain was down to a 4 and nothing of significance was noted by EMS on the heart monitor. Client was given the option to be taken to the ER and she consented to transportation.
71 2021-03-25 palpitations Pfizer COVID-19 Vaccine EUA Patient became feeling like her heart was racing. 30 min monitoring bp ... Read more
Pfizer COVID-19 Vaccine EUA Patient became feeling like her heart was racing. 30 min monitoring bp was 170/88 p 88 oxygen 99 resp 18. Was given juice and monitored for 30 minutes.
71 2021-03-25 heart rate irregular, blood pressure increased Rapid pulse and rise in blood pressure
71 2021-03-25 heart rate abnormal, body temperature decreased The first injection was uneventful. 30 hours after the second injection, respectively, patient sudde... Read more
The first injection was uneventful. 30 hours after the second injection, respectively, patient suddenly became dizzy. VS assessed. BP 90s/40s, which is abnormal for her, HR 30's which is abnormal, and temperature 95.1 orally. She became lethargic. EMS called and confirmed the same VS. Atropine give three times according to protocol without change in HR. Epinephrine dose given with some improvement in HR, but unable to sustain. Pt transported via EMS to Hospital where she was warmed mechanically, started on an IV epinephrine drip and transported to the cardiac ICU where she was monitored for 2 days. Clinically the patient improved after her body temperature normalized.
71 2021-03-25 heart flutter heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day... Read more
heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day after the vaccination; 6th day after the shot she had hot flashes and swelling; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Feb2021 as SINGLE DOSE for COVID-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. Medical history included allergies to penicillin and some other things. There were no concomitant medications. The patient experienced heart fluttering and dizziness 2nd day after the vaccination; repeated 3rd day after the shot; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness. All events started in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was given for the events. The outcome of all events was unknown. Information on the lot/ batch number has been requested.
71 2021-03-26 hypertension tired, headache in back of head, dizzy, warm chest, hypertension, evaluated by EMS, transported to E... Read more
tired, headache in back of head, dizzy, warm chest, hypertension, evaluated by EMS, transported to ER
71 2021-03-27 body temperature decreased Recd. 1st vaccine at 9:15 am, by 4:00 pm was not feeling well, went to bed. for the following 3 day... Read more
Recd. 1st vaccine at 9:15 am, by 4:00 pm was not feeling well, went to bed. for the following 3 days I had body aches, extreme chills, night sweats and nightmares, explosive diarrhia, extreme fatigue (slept 23 hours a day). Each following day I slept a little less, but the night sweats and fatigue lasted for 17 days. My temperature remained around 95.7. This is the sickest I have ever felt, even sicker than the Flu I had approximately 30 years ago! No reaction to 2nd vaccine!
71 2021-03-28 fast heart rate Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swel... Read more
Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
71 2021-03-30 palpitations Headache; Fever/fever reaching 99.7F; Chills; pain in the arms; I am a bit nervous in getting the se... Read more
Headache; Fever/fever reaching 99.7F; Chills; pain in the arms; I am a bit nervous in getting the second dose that I am getting palpitations; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 13Jan2021 (Batch/Lot Number: EH9231) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Mar2020 to Mar2020. The patient had the covid virus in Mar2020. The patient's concomitant medications were not reported. It was reported that she has a question, if a person had the covid virus earlier last year is it still okay to get the Covid vaccine. The first dose was given 13Jan2021. The patient had the covid virus in Mar2020. Caller clarifies that she is actually the patient in this case, and she is speaking about herself. Caller had the covid virus on Mar last year, relatively mild infection. She received the Pfizer vaccine last 13Jan2021. She spoke to a nurse last week since she started experiencing side effects, and was wondering if it was safe that she got vaccinated in the first place considering she had the covid disease prior. Caller mentioned experiencing side effects after the first dose of the vaccine, including severe headache, fever reaching 99.7F, chills, and pain in the arms (akin to getting the flu vaccine but worse). These symptoms have calmed down in a couple of days. She talked to her HCP about this who gave her tylenol but apparently did not do much in managing it. She wants to know if these side effects were expected from the vaccine. Patient was a bit nervous in getting the second dose that I am getting palpitations. Outcome of the events was unknown.
71 2021-03-30 pulmonary embolism, deep vein blood clot Right lower extremity DVT; Bilateral PE; Severe fatigue; This is a spontaneous report from a contact... Read more
Right lower extremity DVT; Bilateral PE; Severe fatigue; This is a spontaneous report from a contactable physician. A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9269) via an unspecified route of administration on 25Feb2021 at a single dose for COVID-19 immunization. Medical history included Allergies: adhesive, CT scan dye & flu shot. Concomitant medication included rosuvastatin. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient also previously took Demerol, guaifenesin;phenylephrine hydrochloride (ENTEX), epinephrine, amoxicillin;clavulanic acid (AUGMENTIN) and experienced allergies. On 03Mar2021 17:15 the patient experienced severe fatigue, right lower extremity DVT, Bilateral PE. Events were considered serious, due to hospitalization for 1 day and life threatening. Treatment was received for the adverse event which included apixaban (ELIQUIS). The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 with unknown result on an unknown date. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. Outcome of the events was recovering. Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
71 2021-03-30 hypotension Within 1st 8 minutes my vision became very blurry, i could not focus.; lightheaded; BP was low end 9... Read more
Within 1st 8 minutes my vision became very blurry, i could not focus.; lightheaded; BP was low end 95/54; This is a spontaneous report from a contactable 71-year-old non-pregnant female consumer reported for herself that she started to receive first dose of bnt162b2 (Pfizer-BioNTech EUA, Formulation: Solution for injection, Batch/lot number: EN5318), via an unspecified route of administration on 09Feb2021 09:30, at single dose in left arm for covid-19 immunization. The patient's medical history included type 2 diabetes, mild hypertension and known allergies: Compazine, Phenothiazines, Oxycodone, Loratadine. Concomitant medications included dulaglutide (TRULICITY), canagliflozin (INVOKANA), METFORMIN, LISINOPRIL, and PRAVASTATIN. No other vaccine in four weeks. The patient received the vaccine at hospital. On 09Feb2021 09:45, within 1st 8 minutes her vision became very blurry, she could not focus, and she became lightheaded. The nurse checked her vitals, and they were normal (BP was low end 95/54) After nearly an hour her vision cleared and she was able to stand up and walk. The events were resulted in Doctor or other healthcare professional office/clinic visit. The patient did not take any treatment for the events. The outcome if the events was recovered on an unknown date.
71 2021-04-01 platelet count decreased Platelets dropped to 12,000/Platelet was dropped to 25 (units not specified); This is a spontaneous ... Read more
Platelets dropped to 12,000/Platelet was dropped to 25 (units not specified); This is a spontaneous report from a contactable healthcare professional (female). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), second dose via an unspecified route of administration, administered in Arm Right on 16Feb2021 15:45, single dose for covid-19 immunisation. Medical history included ITP, from an unknown date. The patient had her first dose of bnt162b2 vaccine on an unspecified date for COVID-19 immunisation. Concomitant medication included methylphenidate hydrochloride (CONCERTA). Platelet was dropped to 25 (units not specified). Patient's platelets was dropped all the way after the second dose (16Feb2021) and she had to take Prednisone. Start date of event, Nurse stated, 4 days later. (Confirmed the date as 19Feb2021). CBC Date: Nurse stated, Last one I had it was every day since the day before the vaccine and today. Results: Nurse stated, platelets went down to 12,000. Patient is now on Prednisone, so her platelets are up. The outcome of the event was unknown.; Sender's Comments: Based on a plausible temporal association, a possible contributory role of vaccination with BNT162B2 to the reported event platelets decreased cannot be excluded. The history of ITP may have provided the contribution to the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
71 2021-04-01 cerebrovascular accident ear infection; nauseous; felt the room spinning; she thought she was having a stroke; lightheaded/ d... Read more
ear infection; nauseous; felt the room spinning; she thought she was having a stroke; lightheaded/ dizzy; This is a spontaneous report from a contactable consumer, the patient. A 71-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 10Mar2021 between 3:15PM-3:30PM (Batch/Lot Number: EN6206) (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included cessation of smoking as the patient stated that she quit smoking in either 2006 or 2007, ongoing blood pressure high from 1986, edema from 2012, hypothyroidism since about 2012-2013, high cholesterol for about 6-7 years and took simvastatin, potassium low from 2012 as she stated that she found out she had low potassium in 2012 when she had blood work done before she was scheduled for surgery and took potassium chloride (KLOR-CON), she used a walker a lot of the time and she stated that her weight fluctuated. She said that her current weight was the heaviest she had been. She said that she gained weight when she quit smoking. She said that she had hypothyroidism, and was old, which didn't help her weight. There were no concomitant medications. Family medical history relevant to adverse events (AE(s)) was not provided. The patient did not receive any other vaccines within four weeks prior to BNT162b2. The patient did not administer additional vaccines on the same date of BNT162b2. She mentioned that she received the first dose of BNT162b2 on 10Mar2021, a Wednesday. She said she didn't notice until the following Sunday on 14Mar2021 that she was lightheaded and dizzy. She said at first she thought she got up too fast, and that was what made her lightheaded. She specified on the Monday morning that it was really bad, she got lightheaded when she was got down on the floor at home doing her therapy and she felt the room spinning on 15Mar2021. She said that her symptoms got worse on Monday night on 15Mar2021 when she laid down in bed. She said that she tried to sit up in bed for as long as she could. She said as long as she was sitting up in bed, she wasn't lightheaded and the room didn't spin. She said she thought maybe she was getting an ear infection, so she took her fingers and plugged her ears for 30 seconds to see if that would help. She said that she had no pain or ringing in her ears. She said eventually she was able to lay down in bed and go to sleep. She said she didn't know what was going on. She said her symptoms were so bad on Monday (feeling lightheaded and the room spinning) that she thought she was having a stroke; and she had to grab on to the bed, got on her knees for she didn't know how long, and it did go away. She mentioned that every time she laid down, the room spun, and she had been dizzy and lightheaded ever since. She said that she was not expecting side effects after that much time had gone by from getting her BNT162b2. She said that the lightheadedness, and room spinning was still going on. She further said that as she was cradling the phone in her neck to do some work while she had been on hold for agents, she felt nauseous on 18Mar2021, but she moved around and she was fine now. She said that she thought the nausea was caused because she had been sitting at her desk working with the telephone cradled in her neck and her head looking down. The patient underwent lab tests and procedures which included potassium was on an unspecified date and weight: 175-180 lbs on an unspecified date as she stated that her weight fluctuated. She said that her current weight was the heaviest she had been. She said that she gained weight when she quit smoking. She said that she had hypothyroidism, and was old, which didn't help her weight. The adverse events, she thought she was having a stroke, lightheaded, dizzy, felt the room spinning and nauseous, did not require a visit to emergency room or physician office. The outcome of events, lightheaded, dizzy, felt the room spinning and nauseous, was not recovered, the outcome of events, she thought she was having a stroke and ear infection was unknown. The patient was due to get her second dose of BNT162b2 on 31Mar2021.
71 2021-04-03 transient ischaemic attack Six days after receiving the vaccine I woke up on Friday, March 12, with a complete feeling of exhau... Read more
Six days after receiving the vaccine I woke up on Friday, March 12, with a complete feeling of exhaustion. Weakness was extreme in my whole left side and could barely put weight on the left side. I thought this would pass so tried to get along. The next day, Saturday, March 13, the complete exhaustion was even worse. Trying to get out of bed was very hard. I called a friend and went to hospital here . I was admitted, tested, and kept for several days. The report came back that I had a series of "mini" strokes on the right side of my brain, affecting the left side of my body. I could no longer walk at all without aide of person or a walker, After that I was taken to rebab, . I was given pt, OT, etc, and discharged several days later. No doctor or staff could tell me whether this was caused by the vaccine but the close days of administering the vaccine and the sudden onset of symptoms make me very concerned. How can I take a 2nd vaccine without knowing if that will have a worse effect or kill me? Can I take a different vaccine for the 2nd round, without a risk of something worse happening? Can you report to me if there is any correlation at all between this vaccine and my mini strokes?
71 2021-04-09 cerebrovascular accident Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan... Read more
Slurring speech and then exhaustion. So on March 22nd ER visit. Tests taken: Blood test and CAT Scan. All came back normal. March 26, MRI done. That showed a stroke. Then on March 31st, saw Drs. (neurologist). Confirmed the stroke and suggested Speech Therapy. Starting on April 19, Sppech Therapy begins. Since Stroke, I have to sleep 12-15 hours a day.
71 2021-04-09 palpitations, hypertension allergic reaction/anaphylactic reaction; heart started pounding and racing; high blood pressure 220/... Read more
allergic reaction/anaphylactic reaction; heart started pounding and racing; high blood pressure 220/118; throat felt funny; This is a spontaneous report received from a contactable Nurse (Patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 23Mar2021 14:30 (Batch/Lot Number: ER8730; Expiration Date: Jul2021) at the age of 71-year-old as single dose for covid-19 immunisation. Medical history included low magnesium, low vitamin D, allergy to Band-Aids, skin adhesives, and allergy to polyurethane spray tan (She's had a reaction to polyurethane on wood floors at her dad's house. Her throat started tightening and it was hard to breathe. She couldn't be in the house until they were finished with the floors. She had to stay in a hotel. She's also had a reaction to spray tan. After the spray tan was finished she had the tightness in her throat. She went to the emergency department and was given Benadryl and her reaction stopped after a short amount of time), She had a mole removed from her leg a couple years. Concomitant medications included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; magnesium taken for low magnesium from an unspecified start date and ongoing; colecalciferol (VITAMIN D) taken for vitamin D decreased, start and stop date were not reported. The patient had allergy to Polysporin (Johnson and Johnson NDC30036385, Lot#103812, Expiry Jan2020), Polysporin caused a bad skin reaction, it was awful. She can only use plain bacitracin. Some make ups she can't use. She's had no problems with creams. Foods are ok. She had a mole removed from her leg a couple years ago and she put the polysporin on the wound and that's when she had that reaction. It was bad around the incision, that wound took a long time to heal because of that sensitivity. She also can't take zinc oxide because it caused an allergic skin reaction, she also had allergy to Epinephrine, She had a reaction happen to her at the dentist. She was given epinephrine and her heart started pounding and racing. The dentist put her in a shock position. The dentist told her it would pass but it was scary. The patient previously also received Antihistamine for allergy. The patient experienced heart started pounding and racing (medically significant) on 23Mar2021, high blood pressure 220/118 (medically significant) on 23Mar2021, throat felt funny (medically significant) on 23Mar2021, allergic reaction/anaphylactic reaction (medically significant) on 23Mar2021. Events were considered as related to Covid 19 Vaccine by reporter. Event required a visit to Emergency Room. The clinical course as following: She received her first Covid 19 vaccine yesterday, on 23Mar2021. After she received the Covid 19 vaccine she walked down the hall to wait in the other room. When she sat down in the other room her heart started pounding and racing. The nurse took her pulse and took her blood pressure. The nurse asked her if she had high blood pressure and she does not have high blood pressure, she has low blood pressure. And the nurse told her that her pulse was fast. A second nurse came in to recheck her blood pressure and she got a high reading as well. The nurses called the nurse practitioner in also. The nurse practitioner said the caller should go to the emergency department. Her throat also felt funny but not bad. She has had reactions in the past when her throat got tight. In the emergency department she received 2 Benadryl, 50mg of Benadryl. They checked her out in the emergency department. The doctor checked her out. She was hooked up to monitor and she stayed for 4-5 hours in the emergency department in case there was a rebound effect. She was discharged from the emergency department. She reports her pulse was 118 beats per minute. She felt like it was higher than that. Her blood pressure was 220/118 the first time. She takes her blood pressure at home and it runs 118-120 over 68-72. The sensation after the Covid 19 vaccine was her heart started pounding. Her heart was moving she could see it pounding. She asked the emergency room doctor what does she do about the second Covid 19 vaccine. She is scheduled for the second Covid 19 vaccine on 15Apr2021. The doctor told her he wasn't sure about that. The doctor advised her to call the CDC and let them know what's going on. She did not speak to anyone at the CDC, she left her contact information for a call back. She found the number for Pfizer and called it. The symptoms lasted about 1-2 hours before the pulse came down to the 90's (beats per minute). The blood pressure came down quicker then the pulse did. Probably within the hour her blood pressure was down to 158 over something. In the emergency department she was instructed to take Benadryl 25mg every 6 hours for 24-48 hours. She's not back to her perky self, but her heart rate and blood pressure is normal. She took 25mg of Benadryl last night, 23Mar2021 then 25mg of Benadryl this morning, 24Mar2021. She's not taking it right at every 6 hours. And she'll take the Benadryl for only 24 hours. She reports it's unnerving for this to happen to her. It helped her that her blood pressure was coming down and they didn't have to give her any other medication besides the Benadryl. She felt like she was in a safe place in the emergency department. She kept drinking water the whole time, she likes to drink a lot of water and she also did some deep breathing exercises. She gets anxious when things like this happen to her. She felt this was medically significant because she didn't know what caused it. Is something in the vaccine that might have caused this to happen. When probing for relevant tests, she reports she had no tests done in the emergency department. They only maintained her on a heart rate monitor and took her blood pressure. She had no IV or anything like that. All the signs and symptoms of the anaphylactic reaction was described as high blood pressure, heart was racing, throat felt funny. Time of onset was minutes after receiving the vaccine, symptoms lasted about 1-2 hours. Patient require medical intervention included Antihistamine, Benadryl 50mg. Patient seen in the Emergency Department, she was monitored in the emergency department for about 4-5 hours on a heart rate monitor and had her blood pressure taken. The patient was not hospitalized. Organ involvement Cardiovascular: Hypertension 220/118, Tachycardia 118 beats per minute. The event was not required the initiation of new medication or other treatment or procedure. Patient's outcome following the potential anaphylactic reaction was Recovering. No laboratory tests or diagnostic studies performed. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient hasn't received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The outcome of the events was recovering.; Sender's Comments: The reported anaphylactic reaction described as high blood pressure, palpitation and oropharyngeal discomfort was likely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship and clinical course of the events.
71 2021-04-14 hypotension, fainting Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 -... Read more
Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 - Hypotension M25.551 - Right hip pain Z79.01 - On apixaban therapy
71 2021-04-15 hypotension 71- year old woman with past medical significant for hypertension on 10 mg of Lisinopril daily for m... Read more
71- year old woman with past medical significant for hypertension on 10 mg of Lisinopril daily for many years. She had her first dose of Pfizer vaccine two weeks prior to admission (3/11/21). After her vaccination, patient felt unwell and dizzy in the mornings. She felt persistent fatigue and had a decreased appetite. The week prior to admission she noticed a decrease in her urine output. She denied NSAID use. Her primary care physician ordered blood week and her Cr was found to be 16.54 and BUN of 163, phosphate of 17.5. Her last known Cr prior to her admission was 18 months prior and was 1.17. She was asked to present to the emergency room. Renal ultrasound showed no hydronephrosis or stones. Urinalysis showed 1+ protein, spec grav of 1.023 with a urine protein/creatinine ratio of 0.09. Urine sediment was unremarkable. Her temperature was 95.6 and her BP was as low as 75/46 and she was put on a low dose of levo. CRP was 202.3. COVID was negative. CK wnl. ANA + to 1:160 (dsDNA, Smith, RNP, SS-A, SS-B all negative). Blood smear was negative. Cultures were all negative. Echo showed an EF of 68% with trivial pericardial effusion. Patient was oliguric, and then initiated on hemodialysis. Renal biopsy was performed. The biopsy consists of one fragment which is stained with H&E, PAS, Trichrome, Jones Silver, and HPS stains. Review of all stains reveals 12 glomeruli, one of which is globally sclerotic. The architecture of the kidney is well-preserved. There is interstitial fibrosis with proportional atrophy involving 10% of the biopsy tissue. There is a focal interstitial infiltrate consisting of lymphocytes involving <5% of the interstitium. The tubules show diffuse acute tubular injury. Calcium oxalate crystals are present in seven tubular profiles. The glomeruli show expansion of Bowman's capsule. The mesangium shows normal cellularity. The vessels show no abnormalities. IMMUNOFLUORESCENCE MICROSCOPY: Frozen sections are stained for IgA, IgG, IgM, C3, C1q, kappa, lambda, and fibrinogen. All immunofluorescence stains are negative. ELECTRON MICROSCOPY: Specimens are prepared for electron microscopy and semi-thin sections stained with toluidine blue are reviewed prior to thin sectioning for ultrastructural examination. Electron microscopy demonstrates patent capillary loops. The glomerular architecture demonstrates segmental corrugation of basement membranes with increase in lamina rara interna. No subepithelial deposits and no intramembranous deposits are identified. The tubules show dilated mitochondria and injury. There is segmental effacement of foot processes. There are no subendothelial deposits. Mesangial electron dense deposits are not identified. Patient received three dialysis treatments and Creatinine began to improved down to 1.46 within 8 days.
71 2021-04-15 pulmonary embolism, troponin increased, fibrin d dimer increased Patient is a 71-year-old female with history of hypertension, hyperlipidemia, and obesity who presen... Read more
Patient is a 71-year-old female with history of hypertension, hyperlipidemia, and obesity who presents with complaint of acute onset shortness of breath. She reports she was walking around her house earlier when she suddenly became short of breath. She denies any chest pain, numbness or tingling but states that shortness of breath persisted. She denies any tobacco, alcohol or drug use and states she has never had any symptoms similar to this before. Denies any lung disease or heart disease previously. She does have hypertension and hyperlipidemia and is on metoprolol and rosuvastatin respectively which she reports good compliance. Denies family history of MI or strokes. She also denies other symptoms such as nausea, vomiting, abdominal pain, fevers or lower extremity edema. In the ED vitals were found to be within normal limits. EKG was obtained showing diffuse T wave inversions, right bundle branch block, no ST changes, no hypertrophy. Troponin found to be elevated at 0.137, creatinine elevated at 1.3, BUN 26. Chest x-ray was within normal limits. Otherwise lab work was unremarkable. She was given aspirin and Nitropaste Hospital Course: Patient was admitted to the medical floor and remained hemodynamically stable throughout her stay. She actually remained asymptomatic and had no further shortness of breath. She was not hypoxic, at no point required supplemental oxygen. Her troponins however continued to uptrend to 0.389. Cardiology consulted, she was medically optimized with increased statin dose, therapeutic lovenox, and aspirin. Original plan was for cardiac catheterization. However, a d-dimer was ordered which returned elevated to 13.7. CTA was performed which revealed extensive bilateral pulmonary emboli with large clot burden and concern for right heart strain. Echocardiogram showed mildly dilated and hypokinetic RV with mild diastolic dysfunction with impaired relaxation. She was deemed not to be candidate for EKOS. Troponin elevation was felt to be type II NSTEMI 2/2 PE. PE was classified as unprovoked as she has no definite risk factors for this: no prior DVT/PE, no family history of clotting disorder, no evidence of malignancy (UTD with cancer screenings and visits PCP q6m for health maintenance), no cell line abnormalities, no prolonged immobility or long trips or surgeries, no trauma, no hormone or steroid therapies or even antidepressants. She is obese, and has mild CKD. She tested negative for COVID-19 by antigen testing. The only identifiable change in her health habits recently was receiving the first COVID-vaccine dose on 3/18. We discharged her with Eliquis with instructions to taper from 10BID to 5BID after 7 days. As she will be on anticoagulation, the benefit will likely outweigh the risk of receiving the second COVID dose. She will follow up with her PCP and hematology/oncology.
71 2021-04-15 cerebrovascular accident Patient woke up on the 28th complaining of severe pain, nausea and vomiting. Was admitted to healthc... Read more
Patient woke up on the 28th complaining of severe pain, nausea and vomiting. Was admitted to healthcare facility and kept for observation overnight. On the 29th a CT was done and found bleeding in brain/stroke. Airlifted to healthcare facility where Craniotomy surgery was done.
71 2021-04-15 blood pressure increased, cerebrovascular accident Vaccination dates were 05 March 2021 and 26 March 2021. On 05 April, patient was taken to ED with n... Read more
Vaccination dates were 05 March 2021 and 26 March 2021. On 05 April, patient was taken to ED with neurological symptoms and was put on stroke protocol. MRI on 06 April confirmed CVA. Patient was currently taking atenolol for long-standing mild heart arrhythmia. BP was elevated upon check in. On 07 April patient was discharged continuing low dose aspirin and Plavix as well as atenolol and suggested to follow up with a neurologist and her cardiologist. Upon discharge patient did not seem to have any ongoing neurological deficits.
71 2021-04-20 blood glucose increased, platelet count decreased, haemoglobin decreased 4/14-Resident c/o not feeling well and declined scheduled dialysis. c/o bilateral shoulder pain and... Read more
4/14-Resident c/o not feeling well and declined scheduled dialysis. c/o bilateral shoulder pain and fatigue. AP- 44, BP- 80/45, c/o headache, no chest pain and no SOB. Sent to CMC ER- patient deceased on 4/14/2021.
71 2021-04-20 heart attack This 70 year old white female received the Covid shot on 2/25/2021 and died of a heart attack on 4/1... Read more
This 70 year old white female received the Covid shot on 2/25/2021 and died of a heart attack on 4/13/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
71 2021-04-26 excessive bleeding Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a ... Read more
Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a little itchy too; that was the only way that I am able to get some sleep; was miserable; consumer was in pain; hives; the same day I started to itch, it was mild across my breast and my stomach but my thighs and my bottom legs were turning red, swelling; but my thighs and my bottom legs were turning red/Thighs/Legs turned red; but my thighs and my bottom legs were turning red, swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 71-year-old, via an unspecified route of administration on 10Apr2021 13:30 (Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included apixaban (ELIQUIS), tamsulosin, and iron. The patient got her first injection on Saturday, 10Apr2021 at 1:30 pm in the afternoon around 7 o'clock the same day she started to itch, it was mild across her breast and stomach but her thighs and bottom legs were turning red, swelling, hives there too, and she rubbed alcohol (treatment) on this to stop the itch, that seems to helped a little bit, but the swelling was not that bad today but the redness was still there. She has scabs on her, blood was coming through, and slight bee stings all over and thigh on an unspecified date, she used hydrocortisone cream (treatment), she was lucky she have some of that here because she keep that when going or here but she rubbed that on last night and that was the only way that she was able to get some sleep. The patient doesn't think that she was going to get the second shot, she doesn't want to experience that again. It feels like that today it was not that bad itching today but at 71 that was miserable yesterday so probably she would not get the second shot. She hopes that the first one can protect her to a point, but she cannot subject herself to that again, that would be senseless for her to experience that again and get a second shot. The patient also stated that her eyelids have been a little itchy too so hopefully you all understand it was 71 years old was suffering from that kind of misery second time. The patient was unable to probe the more question, patient was in pain and not willing to proceed. The outcome of the events was unknown.
71 2021-04-27 blood pressure increased lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated;... Read more
lost partial vision in my right eye which has been determined to be a AION; blood pressure elevated; weak; dizzy; nauseated; fever; headache; This is a spontaneous report from a contactable consumer (patient). This 71- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 11Mar2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was Public Health Clinic facility. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EN6200) dose 1 on 18Feb2021 04:00 PM, for covid-19 immunization, left arm. No known allergies. The medical history included: Blood pressure abnormal. Concomitant medications included: Prozac, Inderal, Atorvastatin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 09:00 am, Day after 2nd injection, she felt weak, dizzy, nauseated, fever, blood pressure elevated and had an extremely severe headache. That evening I lost partial vision in my right eye, which has been determined to be AION. Vision has not returned at one month out. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included: Blood pressure monitoring and return 13Apr2021. The clinical outcome of the events was not recovered. The patient was not tested for COVID-19 after the vaccination. No follow-up attempts are possible. No further information is expected.
71 2021-04-30 loss of consciousness noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remem... Read more
noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; Large brown circle surround site of shot; bruising surrounding it; some welting. Some tenderness; some welting. Some tenderness; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:30 (at the age of 71-years-old) (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. Medical history included, neuropathy peripheral, drug hypersensitivity, diarrhoea, vision blurred blurred/double vision since Feb, hypertension Mild high blood pressure. Drop in blood pressure and increase in blood pressure month after Covid, chills, MGUS, non symptomatic ascending aorta aneurysm, pronounced cough, fever, sore throat, flu symptom. I had the virus on 30Nov after being unknowingly infected with virus by someone unknowingly with virus, some 8 feet away, with no direct interaction. Experienced fever 4 days later. tested. Virus positive. Excessive flu symptom-pronounced cough, fever, sore throat. treated w/antibodies some 8 days later. The patient received first dose of BNT162B2 for COVID-19 immunization on 10Mar2021 ({Product=COVID 19, brand=Pfizer, Lot number=EN6199, Lot unknown=False, Administration date=10Mar2021, Administration time=12:30 PM, Vaccine location=Left arm, Dose number=1}]. Concomitant medication included hydrochlorothiazide, lisinopril (ZESTORETIC); bupropion hydrochloride (WELLBUTRIN); naproxen (NAPROXEN). Large brown circle surround site of shot, with additional bruising surrounding it. Not noticed until 18 days after 2nd shot, some welting. Some tenderness. Don't know when first appeared, does not appear to be fading. No reaction after first shot. (There was sudden unexpected loss of consciousness after sudden slumping. Wednesday eve before noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes. Mild concussion with symptoms. Amnesia at time of loss of consciousness. Do not know if two are related. Deep brown circle on left arm noted 2 day later. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Nov2020. The outcome of the events was not recovered.
71 2021-05-12 chest discomfort This is a spontaneous report from contactable Nurse (the patient). A 71-year-old female received BNT... Read more
This is a spontaneous report from contactable Nurse (the patient). A 71-year-old female received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration in the left arm on 20Feb2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history included allergies to Nitrofuradantoin from an unknown date and unknown if ongoing. Concomitant medication included probiotics (PROBIOTICS), ergocalciferol (CALCIFEROL VIT D), ascorbic acid, biotin, calcium, equisetum arvense stem, ferrous fumarate, nicotinamide, panicum miliaceum seed, proteins nos, shark cartilage (VIVISCAL ADVANCED HAIR HEALTH) and colecalciferol, ubidecarenone (COQ10 + D3). The patient reported that, after approximately 10 min after receiving vaccine her lips and tongue became numb. Slight throat constriction and heaviness in chest -15min later. The patient stated that, she got the 1st dose on Saturday, 20Feb2021. While she was there waiting after she got her injection, about 10 minutes, all the sudden her mouth and tongue became numb. So, she called the EMS guy over and asked him if she was having a reaction, he said that it probably was and asked her if she felt like her tongue or throat was swelling. States that she did not feel like they were swelling, but she did feel a little constricted in her throat. Stated that she still has the numbness, though it was a little less in her lips, but now her right cheek was numb on 23Feb2021. The patient experienced right cheek numbness on 23Feb2021, after approximately 10 min after receiving vaccine my lips and tongue became numb on 20Feb2021 16:10 with outcome of not recovered on 20Feb2021 16:10, slight throat constriction and heaviness in chest -15 min later on 20Feb2021 16:25. The event was assessed as medically significant. The patient was not tested for COVID-19 since the vaccination. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Hypoasthesia,Throat constriction,Chest discomfort.. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
71 2021-05-13 hypertension Throat constriction could not swallow; Throat constriction could not swallow; Blood pressure high 22... Read more
Throat constriction could not swallow; Throat constriction could not swallow; Blood pressure high 225/170; It wasn't right on site; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199, Expiration date was not reported), via an unspecified route of administration in right arm on 01Mar2021 09:15 as first dose single for covid-19 immunisation. Medical history included migraines, fibromyalgia, arthritis, Known allergies to tetracycline, Iodine, Ecklonia Kurome, degenerative joint and Osteoarthritis. Concomitant medications included sumatriptan, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET), rosuvastatin calcium (CRESTOR) all are taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfacetamide and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient experienced throat constriction could not swallow/blood pressure high 225/170 on 08Mar2021 02:00. Patient received the 1st dose of the Pfizer vaccine on 08Mar2021. She had adverse events after the 1st dose and was rushed to the ER, but they were able to stabilize her. She is wondering if she would be a candidate for the 2nd dose which is scheduled on 12Apr2021. She also mentioned that she had a check-up, and she was told that she can get the 2nd dose. She was asked to bring her EpiPen with her and take some antihistamine prior to getting the 2nd dose. She was asking maybe Pfizer has some advice for her as well. Patient ended up being taken in the ambulance to ER with an adverse reaction. It was a delayed reaction. It was not right on site on an unspecified date in Mar2021, right after I had the shot that it was a delayed reaction and I ended up in emergency in the ER. As per the reporter seriousness criteria reported as medically significant. Patient received treatment of IV drip methylprednisolone sod succ (Solution-MEDRO) for adverse events. The patient underwent lab tests and procedures which included blood pressure: 225/170 on 08Mar2021. The outcome of the event vaccination site discomfort was unknown and not recovered for other events. Information on Lot/Batch number was available. Additional information has been requested.
72 2021-01-04 hypertension arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she coul... Read more
arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she couldn't get warm at first and then she is cold; high blood pressure/blood pressure was high 190/116; big toes hurting; nausea; dizziness; feeling weakness legs/Leg feeling weak; This is a spontaneous report from a contactable other HCP reporting for herself. A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: CJ1686), via an unspecified route of administration in the right arm on 28Dec2020 15:00 at single dose for COVID-19 immunisation. Medical history included breast cancer on the left side, hypertension, hiatal hernia, glaucoma, heart disease, hypertension, lymphadenectomy (lymph nodes being taken out was about 20 years before) and headache from 27Dec2020. She was working Sunday into Monday morning and she went to the Director of Nursing, and said she has a Headache on the left side of the temple, and so she went to eye doctor, and he had a test order ESR and so she has a hemorrhage in the left eye, and show she doesn't know if this could be bringing on some of the side effects she was speaking about, like the nausea and the migraine. She has had No positive test for COVID prior to the vaccine, she must have had about 20 tests and all were negative. She has not had any Antibody tests. She had pneumonia vaccine maybe in the last 5-3 years and flu vaccine in Oct2020 and she experienced achy arm. On 28Dec2020 the patient experienced leg feeling weak (about 15 minutes after injection), nauseous at 21:00, dizziness. On 29Dec2020 the patient experienced arm hurting (in the morning), lymph nodes hurting on the left side, chills, blood pressure was high 190/116, big toes hurting. The patient was calling to ask if these side effects she was experiencing were normal. On 29Dec2020 the patient underwent ESR with unknown results. The patient reported that her arm hurting began on 29Dec2020 in the morning. The breast cancer diagnosis was prior to the vaccine as well as her lymph nodes being taken out was about 20 years ago. Her Lymph nodes hurting on the left side started on 29Dec2020 in the morning. Her Leg feeling weak started right after the injection, about 15 minutes after on 28Dec2020. The chills started on 29Dec2020 in the morning in which she couldn't get warm. Her feeling nauseous started on 28Dec2020 in the evening like 9 PM. The Temperature 98.1 was her current temperature taken right before the call, as well as her blood pressure. Her feeling dizzy started after getting vaccine on 28Dec2020, she was fine to drive home, but then again on 29Dec2020 in the morning she felt it also. Her legs felt funny like rubbery. The big toes hurting started an hour before, on 29Dec2020 it woke her up since it was jabbing. The outcome of the events was unknown.
72 2021-01-11 arrhythmia, fast heart rate I got real bad tachycardia and arrhythmia
72 2021-01-18 platelet count decreased I have a chronic low platelet problem, the previous readings had risen to 65, but 5 days after inj... Read more
I have a chronic low platelet problem, the previous readings had risen to 65, but 5 days after injection they were down to 45. Does this vaccine affect platelets? ! ! Should I proceed with 2nd vaccination shot? !!
72 2021-01-18 hypotension joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (1... Read more
joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (100.6); hypotension; hypoglycemia; lethargy; the 2nd dose on 08Jan2021 /1st dose on 20Dec2020; This is a spontaneous report from a contactable Physician (patient). This 72-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 08Jan2021 05:00 PM at single dose (lot number: EK9231) for covid-19 immunisation. Medical history included diabetes, idiopathic encapsulating peritonitis and known allergies to Latex. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), tamoxifen, apixaban (ELIQUIS), simvastatin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at left arm on 20Dec2020 01:00 PM for covid-19 immunisation. The patient experienced chills began 19 hours after injection, followed by low-grade fever (100.6), hypotension, hypoglycemia, lethargy, confusion and anorexia on 09Jan2021 12: 00 PM. Illness lasted 17 hours, treated with fluids, anti- inflammatories and sleep. Some new joint pain persisted. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event joint pain persisted was unknown. Outcome of other events was recovered/resolved with sequel.
72 2021-01-19 fibrin d dimer increased, chest pain, pallor, pulmonary embolism Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heavi... Read more
Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heaviness in chest rated at 7/10 pain scale, mandibular pain, appeared diaphoretic and fatigued, skin grey/pale, though remained alert and responsive to questions appropriately. Patient also communicates she was having some chest pain prior to the immunization today, though she indicated on her forms that she was feeling well today. Vital signs assessed, P72 R16 O2 99, patient denied difficulty breathing. Rapid response protocol initiated, applied 2L O2 via NC, transferred patient to wheelchair and taken to ED for evaluation by response team. ED assessment reveals calf tenderness and patient reporting TKA x 2 weeks ago, elevated D-Dimer, CT results pending at this time.
72 2021-01-21 lightheadedness Patient had an increase in chronic headache frequency and had a near-syncopal episode on 1/21/21. Sh... Read more
Patient had an increase in chronic headache frequency and had a near-syncopal episode on 1/21/21. She stated that the near-syncopal episode lasted for about 10 minutes. She has had one prior episode that was caused by hypotension and dehydration.
72 2021-01-22 loss of consciousness, heart rate irregular Appx 36 hour after shot had irregular heart beat. Then extreme dizziness resulting me passing out .... Read more
Appx 36 hour after shot had irregular heart beat. Then extreme dizziness resulting me passing out . After regaining consciousness, symptoms were gone.
72 2021-01-22 heart rate increased Rapid heartbeat, rash, hives, itching, felt flushed, no fever. I still have mild symptoms.
72 2021-01-24 chest pain, blood pressure decreased, blood pressure increased 1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after t... Read more
1st covid shot on 1/16/21. Then on 1/19/21 I had ortho inject a steroid in my thumb. Right after the steroid shot, I started reactions---Severe headache, chills, nausea, cough, upper chest pain, severe weakness, blood pressure up and down. Went to family doctor 1/22 and covid shot in office showed negative. Worse on 1/24/21 and went to ED. They did a chest x-ray, CTA chest, lots of bloodwork and covid test that took 2 hours to receive results. All was negative except the D-dimer test. Thye thought it might be a result of the 2 injections within days of each other.
72 2021-01-24 chest pain Chest pain began within 2-3 minutes after receiving the vaccine.
72 2021-01-24 atrial fibrillation Pt developed Afib at 2AM on 1/23. Started on amiodarone and Xarelto
72 2021-01-26 heart rate irregular Erratic heart beat; This is a spontaneous report from a contactable consumer (patient). A 72-year-ol... Read more
Erratic heart beat; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: lot number: Elo140), via an unspecified route of administration on left arm on 11Jan2021 13:00 (first dose) at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. Patient had no COVID prior vaccination and no known allergies. Concomitant medications included other medication (taken other medication in two weeks). The patient experienced erratic heart beat on 11Jan2021 14:00. The event resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the event. The patient was not COVID tested post vaccination. The outcome of the event was not recovered.
72 2021-01-26 hypotension, low blood oxigenation Resident had an episode of hypoxia and hypotension
72 2021-01-28 blood pressure decreased 12 minutes after receiving shot began to feel sweaty and light headed and like I was going to faint ... Read more
12 minutes after receiving shot began to feel sweaty and light headed and like I was going to faint - felt like something was going on with my heart.
72 2021-01-28 chest pain, chest discomfort awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt ... Read more
awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt woozy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration in the right arm on 13Jan2021 at 17:39 at a single dose in the hospital for covid-19 immunisation. Medical history included anxiety, seizures, and high cholesterol. She passed out last summer and they put her in the hospital from 31Aug2020 and ran all kinds of tests. In the end, they said she only had a few PVCs (premature ventricular contractions) and she doesn't need to see the doctor for a year. Mentioned she also has chronic bronchitis and this is related to having low platelet count and low immunity. All of these events predate treatment with Pfizer COVID 19 vaccine. Concomitant medication included amlodipine, atorvastatin for high cholesterol, clonazepam for seizures, escitalopram for anxiety, levothyroxine sodium for thyroid, and mirtazapine for sleep; all were ongoing. Stated that she had something weird happen after her injection about four hours after the shot. She received the first dose of the Pfizer COVID 19 vaccine on 13Jan2021 at 17:39 in the right arm. About three or four hours later on 13Jan2021, she was getting ready for bed and when she sat down and leaned over she had a god awful burning in her chest and nausea. She was going to take baking soda but when she sat up she had horrible pressure and pain in her chest and felt woozy so she sat on the floor and then the pain started to radiate through her arm and into her neck. The horrible pain and pressure in her chest felt like something was sitting on her chest and the bad pain in her chest was going into her arm and a little into her neck. She laid real still on the floor, and did a lot of praying, and then 20 minutes later it totally stopped. She got up slowly and finished getting ready for bed and was fine. She was just hoping they will still let her get the second shot. The whole event only lasted 20 minutes and when it was over it was completely gone. She did tell her husband when he came home. She was alone when this happened. The patient wanted to know if she can receive second dose of vaccine. She stated it almost felt like a heart attack. She was planning to get the second dose on 03Feb2021. Wanted to know if her effect will preclude her from getting the second dose of the vaccine. Outcome of the events was recovered on 13Jan2021.
72 2021-02-01 heart rate irregular Heartbeat irregularities & "thumps" and intense headache -- both starting 6-8 hrs after injection an... Read more
Heartbeat irregularities & "thumps" and intense headache -- both starting 6-8 hrs after injection and lasting 36 hours. Also chills but no fever. Fatigue. I stayed in bed the entire next day.
72 2021-02-01 hypertension her right arm began having a shooting pain that went up to her neck and left breast; her right arm b... Read more
her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; Indigestion; dry mouth; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982) via an unspecified route of administration on the left arm on 15Jan2021 at a single dose for COVID-19 vaccination. Medical history included ongoing heart murmur. There were no concomitant medications. She received the first dose of COVID vaccine on 15Jan2021 in her left arm. Patient stated that 15 minutes after receiving COVID vaccine her right arm began having a shooting pain that went up to her neck and left breast. She was given 4 Aspirin and a Nitroglycerin tablet. She was then transported to (Institute Name Withheld) by ambulance from vaccination facility. While at the hospital blood work was obtained and her pancreas was checked. Patient stated she was there for three hours. She would like to know if she should receive the second dose of the COVID vaccine? Reported she had an adverse event 15 minutes after receiving her first dose of the COVID-19 Vaccine. She said she had pain in her right arm. She said the pain went up to her neck. She said she had pain under left breast. She said she felt like she had indigestion. She said she was told to chew 4 aspirins, clarifying she was given 4 aspirins by the ambulance staff that was at the scene to treat her. Reported she was told her blood pressure was high. She said she doesn't know what her blood pressure reading was because the ambulance staff would not tell her. Reported she noticed she had a dry mouth while she was being transported in the ambulance to the hospital. Reported she was transported by ambulance to the hospital emergency room in (City Name Withheld), (State Name Withheld). She said she was treated and released from the emergency room. Reported her neck pain was gone first, but she still felt like she had indigestion while being treated in the emergency room. Treatment: Reported the hospital staff had her drink something, and then her indigestion, and arm pain went away. She said the hospital did blood work and checked her pancreas. She said she has no information on her blood work results, saying the emergency room doctor didn't share her results with her. She said the emergency room doctor only mentioned that he was checking her pancreas. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event pain in arm was recovered in 15Jan2021, patient recovered from neck pain, breast pain, indigestion and dry mouth in Jan2021; and unknown for the other event.
72 2021-02-01 heart rate increased right after shot, month/lips tingling , fast heart beat, lasted about 4 hours, next day starting itc... Read more
right after shot, month/lips tingling , fast heart beat, lasted about 4 hours, next day starting itching but no rashes, still have some fast heart beat but not like first day. Still itching and every day my face gets real red and hot for about an hour maybe twice a day
72 2021-02-01 hypertension she got it Thursday and that night she noticed a little itching/itching a little again in the palm o... Read more
she got it Thursday and that night she noticed a little itching/itching a little again in the palm of her hands; some face soreness; her BP was 152/85 that was high; she has to got the rash on her behind where she has been scratching; having an allergic reaction; a little puffiness on her lip; the cellulitis part of her skin; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247), via an unspecified route of administration on 14-JAN-2021 at the 72 years old at single dose for COVID-19 immunization. The medical history included COPD so sometimes she would cough, kidney stent, rheumatoid ("two" Tylenol and 20 mg prednisone for "her rheumatoid"). The concomitant medication was clarithromycin (MACROBID) from an unspecified date to 12Jan2021. The patient got it on the 14Jan2021. She says she had been doing fine she didn't know now. She was a retired paramedic so she usually felt things out, she got it Thursday and that night she noticed a little itching on 14Jan2021 but she did not think anything of it. Friday evening she had a good time eating some walnuts and she woke up about 2:30 itching that was Saturday morning before day, she took Benadryl and went back to sleep later then later on she was itching a little again in the palm of her hands and she just took a Benadryl and it went away. Then Sunday night, last night, she was okay so she decided to go to the pharmacy to get some Benadryl, they had no Benadryl and she only had old Benadry. Then about 12:30 she started itching on her bottom, itching on her arms and she was scratching. She noticed she was having some face soreness in Jan2021 but she was using some expired facial cream so she thought that was why her face was sore so she put some hydrocortisone cream on it. Since she was itching she decided to take a little of her nieces Benadryl, it is pediatric Benadryl. She was itching so she called her doctor and she heard him in the ER say they had too many people in there to tell her to go to the ER so she said okay. She hung up and called the pharmacy and they said it sounds like having an allergic reaction in Jan2021 and she told him she had the COVID vaccine but she doesn't think she was short of breath and she gave them her vitals her BP was 152/85(BP 157/85) that was high for her in Jan2021, but it came down, she took some Tylenol then it was 146/77, her pulse rate was 77 and her respirations were good she did not have shortness of breath or cough well she has COPD so sometimes she would cough. Then she got up and said let me go one over and get some Benadryl so she went by there got some good Benadryl and she thought she would call and see what they think about all this. She took the Benadryl at 10:25 and she is doing okay right now but she had whelps, she has to got the rash on her behind where she has been scratching in Jan2021, it is on the left side of her hip, the cellulitis part of her skin that is mostly where she is itching in Jan2021. She remembers when she worked at the health department they would give Benadryl and Prednisone. She thought if the Benadryl does not help then she would call, then she decided she would go ahead and call to see what information they have. She says Pfizer is giving her alerts that she has been answering but she did not have the itching at that time. She retired from being a paramedic in 2009. She says she is 72 now but she woke up in 1985 and her lip was swollen like not totally swollen but her top lip was swollen more than the bottom in Jan2021. They gave her an Epinephrine shot and Benadryl and she is just wondering if this itching is related to the vaccine or if it is just an allergy that she may have come up on or something like to the walnuts or something. She says they went there and they gave the shot and they gave Benadryl but they are not sure. She said the doctor never figured our what it was that cause it and it never happened again until she did notice a little puffiness on her lip again this morning. She said the itching first started around 2:34 AM in the morning before light. It had improved since taking up to date Benadryl. She was supposed to get her second dose 04Feb2021. She didn't want COVID 19. She knew she just came off, she had a kidney stent and she had stopped taking 2 days before, she was taking Macrobid. She was not taking that right now. She took a lot of other medications but the Macrobid she was just on and it was stopped on Tuesday 12Jan2021, 2 days before the vaccine. She didn't know if the Macrobid would interfere with getting vaccine. The outcome of the event itching was recovering, the other events was unknown.
72 2021-02-01 excessive bleeding she has a bleeding disorder/ a cardiac procedure in the groin to stop bleeding; Hashimotos' Disease;... Read more
she has a bleeding disorder/ a cardiac procedure in the groin to stop bleeding; Hashimotos' Disease; Mixed Connective Tissue Autoimmune Disease; allergies (experienced rashes and hives) to contrast dyes; allergies to adhesive, and polymers; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (Manufacturer Control Number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-005628), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021040024) on 18Jan2021 and was forwarded to BMS on 19Jan2021. This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimotos' Disease), MIXED CONNECTIVE TISSUE DISEASE (Mixed Connective Tissue Autoimmune Disease) and HAEMORRHAGE (she has a bleeding disorder/ a cardiac procedure in the groin to stop bleeding) in 72-year-old female patient who received apixaban (ELIQUIS) for an unknown indication. The occurrence of additional non-serious events is detailed below CO-SUSPECT PRODUCTS included COVID-19 VACCINE for an unknown indication. On an unknown date, the patient started ELIQUIS (unknown route) and COVID-19 VACCINE (Intramuscular). On an unknown date, the patient experienced AUTOIMMUNE THYROIDITIS (seriousness criterion medically significant), MIXED CONNECTIVE TISSUE DISEASE (seriousness criterion medically significant), HAEMORRHAGE (seriousness criterion medically significant), CONTRAST MEDIA ALLERGY (allergies (experienced rashes and hives) to contrast dyes) and DERMATITIS CONTACT (allergies to adhesive, and polymers). The action taken with ELIQUIS (Unknown) was unknown. At the time of the report, AUTOIMMUNE THYROIDITIS, MIXED CONNECTIVE TISSUE DISEASE, HAEMORRHAGE, CONTRAST MEDIA ALLERGY and DERMATITIS CONTACT outcome was unknown. Consumer reported that she had read the EUA Fact Sheet for Recipients and have some questions to the "What should you mention to your vaccination provider". Caller mentioned that she has allergies (experienced rashes and hives) to contrast dyes, adhesive, and polymers such as the angio-seal that was used on her for a cardiac procedure in the groin to stop bleeding. She has irritation from the polymer and described it as a sponge that was meant to be absorbed for a month. Her first question was does the COVID-19 vaccine contain latex, mold (polymers) and adhesive? Response: For latex. For mold (polymer) and adhesive: "A review of the ingredients list on the product label show that mold (polymer) and adhesive are not part of the formulation, however, Pfizer does not specifically manufacture the vaccine to be free of mold (polymer) and adhesive, therefore, we cannot assure that it was "mold (polymer)-free and adhesive free". We cannot guarantee that minute amounts of substances are not contained in raw materials obtained from our suppliers. She had the PPSD23/Pneumonia 23 vaccine last 05Jan2021 and was told not to get the COVID-19 vaccine for 14 days. Is it because of the injection site or is it for systemic reasons? Consumer mentioned that she was on ELIQUIS. She has Hashimoto's Disease and Mixed Connective Tissue Autoimmune Disease. She said that she was not immunocompromised. She mentioned that she has a bleeding disorder. The Pfizer- BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection For ELIQUIS (Unknown), the reporter did not provide any causality assessments. Reporter's causality assessment was not provided. Bristol-Myers Squibb Causality assessment for ELIQUIS: Events: Hashimoto's disease, Contrast media allergy, Topical adhesive allergy, Mixed connective tissue disease were considered unrelated while bleeding was considered related. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: BMS Medical Evaluation Comment: This patient had autoimmune thyroiditis, mixed connective tissue disease and hemorrhage after receiving apixaban therapy. This patient also had COVID-19 vaccination. Based on the anticoagulant action of apixaban, its role in the event hemorrhage is considered as possible. Based on the etiology of the reported events, auto immune thyroiditis and mixed connective tissue disorder are considered not related to apixaban.
72 2021-02-03 hypotension, lightheadedness tends to have low blood pressure; Dizziness; she lies down and then gets up she is dizzy; tired; she... Read more
tends to have low blood pressure; Dizziness; she lies down and then gets up she is dizzy; tired; she might have almost fainted as the room was spinning; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284, expiration date 0Apr2021), via an unspecified route of administration in the left arm on 18Jan2021 at 09:30 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history included Reflux esophagitis, COPD and a root canal on 14Jan2021. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020. Past drug history includes sore arm after COVID-19 vaccination on 28Dec2020. It was unknown if the patient has any allergies to medications, food, or other products. The patient's concomitant medications included oral famotidine (FAMOTIDINE) 20mg twice daily for reflux, (tiotropium bromide) SPIRIVA 2.5mcg, two puffs once daily by mouth for COPD, latanaprost (LATANAPROST)125mcg; one drop each eye at night for Glaucoma, (TIMOLOL) 5% one drop twice daily to each eye and (LORATADINE) 10mg; take once daily by mouth as needed for allergy. The patient did not receive any other vaccine within four (4) weeks prior to the vaccine. The vaccine was administered to the patient at the hospital. On 19Jan2021 the patient experienced dizziness and feeling tired. The patient further described that she had the vaccine on Monday and since yesterday, when she woke up, she has a lot of dizziness; and again this morning when she woke up. Also, when she lies down and then gets up she is dizzy. Mentions she didn't see dizziness on the list of side effects. She knows that is a side effect of COVID. She is asking is dizziness is a side effect of the vaccine wants to know if she should call her doctor. She continued and mentioned that she noticed when she was waking up on 19Jan2021 she was so dizzy that she couldn't get out of bed. Adds she thinks she might have almost fainted as the room was spinning. Mentions she tends to have low blood pressure but this is not typical. As far as side effects from the vaccine she mentions she is tired. The tiredness started after the second dose and has continued through today but not as bad. The clinical outcome of dizziness was reported as not recovered, the outcome of fatigue was recovering and the outcome of almost fainted and low blood pressure was unknown.
72 2021-02-06 chest discomfort, blood pressure increased Reports chest tightness and anxiety. Evaluated by EMT. BP in 200's. Pt states she forgot to take h... Read more
Reports chest tightness and anxiety. Evaluated by EMT. BP in 200's. Pt states she forgot to take her BP meds. EKG normal.
72 2021-02-07 fainting 1/21/2021, 4 pm, Covid-19 first shot, Pfizer, Lot EL3246 On 1/24/2021 at 5 am I had bad heartburn s... Read more
1/21/2021, 4 pm, Covid-19 first shot, Pfizer, Lot EL3246 On 1/24/2021 at 5 am I had bad heartburn so I got out of bed, took a couple of TUMS and sat in chair , At 6 am I went to get in bed and felt nausea and started to go to the bathroom but ended up fainting. When I came to I started vomiting., Then my husband had to help me off the floor and get to the bathroom. I was vomiting and had Diarrhea. My temperature was normal. When symptoms subsided in about a half hour time I realized my right foot, leg and knee hurt. At approximately 1 pm my daughter insisted that I go to the ER, where I was treated.They ran a bunch of test but did not find anything seriously wrong with me and sent me home.
72 2021-02-07 palpitations, loss of consciousness Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip f... Read more
Passed out; Little bit sore arm; I woke up, was not able to sleep; My heart was doing kind of flip floppy; Dizzy/ had the dizziness which was severe; Falling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), via an unspecified route of administration on 20Jan2021 at 08:00 AM at single dose because she would like to not get Covid 19. Medical history reported as no. Concomitant medication included levothyroxine. The patient reported that she had bnt162b2 shot on Wednesday the 20Jan2021 about 8 O'clock in the morning, no real problem when she had it, had little bit sore arm but this morning (in Jan2021) about 2 O'clock she woke up, was not able to sleep, moved around a bit, her heart was doing kind of flip floppy, was not thinking much, the next thing she knew, she was extremely dizzy and she passed out, patient was asking could that be a side effect of Covid 19, it was about 36 hours after she had the shot. Patient also stated falling and passing out kind of get you off key. She had the dizziness which was severe and did pass out in Jan2021. No investigation assessment. No treatment was received for the events. The outcome of the events was unknown.
72 2021-02-07 palpitations Patient received COVID vaccine and felt dizzy and nauseating 10 minutes after. Later developed pal... Read more
Patient received COVID vaccine and felt dizzy and nauseating 10 minutes after. Later developed palpitation. Vital and O2 Sat stable. MD on site examined the patient and triaged to send patient to ED. Symptoms recovered when presenting to ED.
72 2021-02-08 nosebleed, blood pressure increased She developed new onset elevated BP, systolic BP 199 with epistaxis, required ER visit and tx for ep... Read more
She developed new onset elevated BP, systolic BP 199 with epistaxis, required ER visit and tx for epistaxis...BP slowly normalized
72 2021-02-09 palpitations At 11:25 am client states she's having shortness of breath and has heart racing. Vital signs obtain... Read more
At 11:25 am client states she's having shortness of breath and has heart racing. Vital signs obtained by EMS: BP 150/78, Pulse 75, O2 sat 99%. At 11:30 am client states she feels better. EMS discharge client home.
72 2021-02-09 lightheadedness Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported dizziness, diplopia... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported dizziness, diplopia, headache, and difficulty with answering questions. Denies chest and abdominal pain and shortness of breath. Patient transported to the emergency department where initial vital signs within normal ranges except blood pressure 170/119 mmHg. Physical and neurlogical exam noted above symptoms with cranial nerves, sensation, and extremty strength intact/normal. Patient's symptoms rapidly resolved without intervention. Repeat vital signs within normal ranges except blood pressure 134/91 mmHg. Determined patient experienced a vasovagal episode. Patient discharged to home stable.
72 2021-02-09 palpitations Racing heart; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old n... Read more
Racing heart; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL3249), via an unspecified route of administration in the left arm on 21Jan2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications included atenolol, bio-identical hormones and deplane (information presented as reported). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 22Jan2021 at 15:45, the patient experienced racing heart. The patient reported that when walking she had to sit down to get heart back in rhythm, the patient was still experiencing the event, even when not walking. The patient stated it was a bit un-nerving and that the patient is a strong walker. The patient did not receive any treatment for the event. The clinical outcome of the racing heart was recovered with sequalae (reported as "Recovered with lasting effects") on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
72 2021-02-09 heart rate increased allergy; cold; heart rate went up to 127, then stayed in the mid 80's; This is a spontaneous report ... Read more
allergy; cold; heart rate went up to 127, then stayed in the mid 80's; This is a spontaneous report from a contactable consumer (patient). This a 72-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date: not reported), via an unspecified route of administration, on 22Jan2021 03:45 PM at a single dose on the right arm for COVID-19 immunization. The patient was not pregnant. The patient had not received other vaccines in four weeks prior to receiving bnt162b2. Medical history included Hashimoto's, and allergy to statins and fluoroquinolones. The patient had no covid prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL). The patient also received another vaccine (unspecified), first dose on 22Jan2021 on the right arm. At about 12:30 or 1:00 pm on Saturday, 23Jan2021, the patient's heart rate went up to 127, then stayed in the mid 80's. She felt like she had an allergy or a cold all of a sudden. She had to rest for a few hours. By 4 pm she felt better. The patient was not tested for covid post vaccination. The patient did not receive any treatment. Outcome of the events was recovered on an unspecified date in Jan2021. Information on the Batch/Lot number has been requested.
72 2021-02-09 heart rate increased raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took m... Read more
raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took my temperature and it was 97.4; My heart rate jumped to 93bpm; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via an unspecified route of administration on 22Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. The patient medical history included hypothyroidism, inflammation and sensitive to grains. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient was not pregnant at the time of vaccination. Approximately 4 hours after patient received the vaccination (22Jan2021 21:45), she felt very warm, and she started itching. Patient developed a rash all over the trunk. Patient took her temperature and it was 97.4. Patient heart rate jumped to 93bpm. Patient took a diphenhydramine hydrochloride (BENADRYL). As soon as the diphenhydramine hydrochloride took effect, her heart lowered pretty quickly. When patient woke up this morning (23Jan2021), she was still itching mildly and raised welts if is scratched. More diphenhydramine hydrochloride four hours ago. Treatment received for the adverse event included diphenhydramine hydrochloride (self administered). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovering. The events were reported as non-serious.
72 2021-02-10 heart rate increased 2:00 am seizure, dizzy, weak, diarrhea, nausea, head pain, rapid heart beat. This got better. 3:30 a... Read more
2:00 am seizure, dizzy, weak, diarrhea, nausea, head pain, rapid heart beat. This got better. 3:30 am bad seizure with foaming at nose and mouth, convulsions, dizzy, unable to move, terrible head pain, nausea, rapid heart beat, extreme hot and cold spells; freezing from bones out. The seizure got bettter after about an hour, but the tremors did not stop until around 6:00 am.The morning of the shot, I ate a banana for breakfast. Only thing I ate after the shot was late lunch was rice with tomatos in it, green beans, fried squash (all out of my garden).
72 2021-02-10 blood pressure increased Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue... Read more
Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated "I was completely aware though a little "foggy". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came. Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned." Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
72 2021-02-10 heart rate increased Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart ... Read more
Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart beat, dizziness and weakness. nausea.
72 2021-02-10 palpitations Patient called and stated that she received her vaccine 2/8/21. She reports that night she went to s... Read more
Patient called and stated that she received her vaccine 2/8/21. She reports that night she went to sleep and woke up around 9:00PM with her heart racing. When she checked it her heart rate was 122. She states that it resolved within about 2 hours. She said the same thing happened the next night. She reports having multiple episodes of feeling like her heart is racing and beating out of her chest.
72 2021-02-10 atrial fibrillation Within 24 hours of the injection my atrial fibrillation reoccurred; This is a spontaneous report fro... Read more
Within 24 hours of the injection my atrial fibrillation reoccurred; This is a spontaneous report from a contactable consumer. A 72-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262), via an unknown route, on 23Jan2021 (at 13:15) at a single dose on the left arm for COVID-19 immunisation, administered at hospital. Relevant medical history included high cholesterol, high blood pressure and atrial fibrillation (she had been treated for Afib in the past but had been off of all medications for many months). Relevant concomitant medications included atorvastatin for high cholesterol and metoprolol for high blood pressure. No other vaccine was received in four weeks. Within 24 hours of the injection, on 24Jan2021 at 13:30, atrial fibrillation reoccurred. Physician office visit was done. Therapeutic measures taken as result of the event included apixaban (ELIQUIS) and dofetilide. An electrocardiogram (EKG) was done and results were unknown. Post-vaccination COVID test was not performed. The patient had recovered from the event in Jan2021.
72 2021-02-10 haemoglobin decreased, blood glucose increased caller ( admitting physician) stated pt got the vax and then she got weak on 1/26/2021. Stated he f... Read more
caller ( admitting physician) stated pt got the vax and then she got weak on 1/26/2021. Stated he felt like she was lifting weight blocks. She went to Medical Center ER and was discharged and fell and in the parking lot. Pt came back to same ER 2 days later and was admitted w/ Guillain-Barre dx. Pt was then treated with IV Immunoglobulins. Labs; Sodium 132. BUN7 , Albumin 2.7, Glucose 112, WBC 3.5 HGB 10.4
72 2021-02-11 heart rate increased Side effects - Headache, Muscle pain, Chills, Joint pain, Fast Heartbeat
72 2021-02-14 palpitations Low grade fever; heart palpitations; This is a spontaneous report from a contactable consumer (patie... Read more
Low grade fever; heart palpitations; This is a spontaneous report from a contactable consumer (patient) A 72-years-old no pregnant female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# El9262 on 27Jan2021 (at age of 72 years old ) in the right arm 08:30 at SINGLE DOSE for covid-19 immunisation . First dose received on 06jan2021 (lot#EI3246) 10:30 in the right arm .The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered:Other. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced low grade fever and heart palpitationson 28Jan2021 07:00 .Events were reported as non serious.No treatment received .Outcome of the events was recovered.No Prior to vaccination, was the patient diagnosed with COVID-19.Since the vaccination, the patient had been tested for COVID-19.
72 2021-02-14 pallor Patient became lightheaded and pale. No syncope. No symptoms/signs of anaphylaxis. Vital signs re... Read more
Patient became lightheaded and pale. No syncope. No symptoms/signs of anaphylaxis. Vital signs remained stable. Symptoms resolved within 45 minutes with laying supine, water, and carbohydrate. Completely asymptomatic before leaving building.
72 2021-02-16 low blood oxigenation, cardiac failure congestive Acute on chronic congestive heart failure, unspecified heart failure type; Bilateral pleural effusio... Read more
Acute on chronic congestive heart failure, unspecified heart failure type; Bilateral pleural effusion; COPD exacerbation; COVID-19 virus not detected; Hypoxia; SOB (shortness of breath)
72 2021-02-17 chest pain, chest discomfort severe pains right underneath her breasts; like a huge belt was tightening and tightening; This is a... Read more
severe pains right underneath her breasts; like a huge belt was tightening and tightening; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: PFREL1283, expiry: 30Apr2021) intramusculary into the right arm on 15Jan2021 15:30 at a single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. On 16Jan2021 04:00, patient started to get severe pains right underneath her breasts, it was like a huge belt was tightening and tightening. Patient thought maybe she was getting a heart attack. It was further reported that at 06:30, it stopped and she has been fine ever since. The patient did not require an emergency room or physician office visit. Outcome of events recovered on 16Jan2021 06:30.
72 2021-02-18 heart rate increased Approximately 40 minutes following the injection, I experienced an increase in heart rate. Not pain... Read more
Approximately 40 minutes following the injection, I experienced an increase in heart rate. Not painful but noticeable. Stopped activity and returned to normal within 30 minutes
72 2021-02-20 blood pressure increased, heart flutter, chest discomfort, heart rate irregular On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontan... Read more
On 2/2/21 I developed chest pressure and irregular heart beat at 4:00 pm. Went to ER and it spontaneously resolved while staff was telling me how they would treat it. Gave me Metoprolol 5 mg IV with 500 IV fluids and discharged. Then on 2/6/21 I slept poorly and felt very jittery and had more chest pressure but pulse was regular. then on 2/8/21 at 6:00 am I awoke and felt terrible with chest pressure. Took my blood pressure at home and it was 193/103, and I was very shaky. Went to ER where they did blood work, X-ray, and monitored my heart and blood pressure for 4 hrs. Gradually my blood pressure came down, and my blood work and X-ray probed to be WNL. I was discharged without medication change but had echocardiogram scheduled and follow-up appt. with Cardiologist, on zoom. He started me on Flecainide 100 mg bid, and stress test on 2/24/21 and follow-up appt. with him on 3/3/21. I also had a follow-up appt. with my GP the day after the first ER visit and she ordered more labs, and the echocardiogram. I have continued to have feelings of fluttering and pressure in my chest off and on and they continued after my second vaccine. But my heart has remained regular since starting the Flecainide. But my blood pressure went up to 150/85 on 2/9/21 and again to 142/81 on 2/10/21 both times with feelings of jitteriness and pressure in my chest.
72 2021-02-21 lightheadedness the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredne... Read more
the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
72 2021-02-22 chest discomfort Patient immediately after vaccine reported anxiety and difficulty talking. Patient took dose of chil... Read more
Patient immediately after vaccine reported anxiety and difficulty talking. Patient took dose of children's Benadryl from home. States she has had this feeling before when exposed to chemical smells. After 10 minutes patient states symptoms are improving. Encouraged to stay for monitoring for additional 30 minutes. After around 5 minutes, the patient notified staff of symptoms reoccuring and worsening. States she is having shortness of breath, chest tightness and difficulty talking. Patietn evaluated and taken to ED for further treatment. Clinic provider notified.
72 2021-02-22 ischemic chest pain angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy... Read more
angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy; muscle aches and heaviness; muscle aches and heaviness; she just woke up feeling sick; fevers may come like a hot flash; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown), via an unspecified route of administration on 23Jan2021 at a single dose, in left arm for COVID-19 immunization. Medical history included fibromyalgia diagnosed years ago, angina (some stents). There were no concomitant medications. On Jan2021, the patient experienced angina, fever, chills, cough, sore throat, runny nose, nausea, diarrhea, headache, arm heavy, muscle aches and heaviness, and she just woke up feeling sick. The patient experienced multiple AEs after 1st dose of vaccine (received on 23Jan2021). The patient experienced angina later last week. Clinical course: The patient has misplaced card, states her second appointment for the second dose is this Saturday. Caller stated she started having these experiences the day after she was vaccinated with her first dose, received first dose of 23Jan2021. She had fevers, chills, cough- not an aggressive cough, a funny kind of sore throat- like something wrapped around her throat like the muscles of her throat, no congestion but does have a runny nose, states she has some nausea, no vomiting but feeling like she needed to vomit and diarrhea, and headache. The symptoms started about the third day after the vaccine, started with the fevers, stated the fevers may come like a hot flash, lasts seconds even, states you know it is a fever because your bones get hot. These symptom's did not attack her body at one time. Her whole arm stayed heavy, the whole arm not just the injection site, for almost 10 whole days. She previously had fibromyalgia and thought maybe that made the symptoms worse. She had muscle aches and feeling heavy. Her symptoms were spread out over time, no two were at the same time, sore throat was one of the last things. Diarrhea was ongoing, not a runny diarrhea but it was enough to empty stomach and was soft. She was a medic in the military, worked as a Nurse, clarifies she was an LPN and took all the underlying courses to be a PA. One of the issues she found, she thought it may be deadly, as a prior healthcare person and in tune to her body, the people who are in the nursing homes may not be mobile, states so one of the things she felt was just feeling really really sick, that she couldn't put a pin point on it, states she just woke up feeling sick, states she had the urge to get out of bed and got up and after she got up the feeling left her, states a person in the nursing home may just feel really bad and cannot get up, thinks a protocol should be that the people that are immobile should be required to move or if they can't get up they need to move their muscles, people with these symptoms need to get up and get moving. She also has history of angina and a stent, has not had angina in a while and had 3 days where she thought she may need to go talk to her doctor. It was on Wednesday, Thursday and Friday this week. States one of her friends, 92 years old, said she got high after the vaccine and didn't want to talk to anybody, states it was her first dose, she was kind of leery about the 2nd shot, feels like this was kind of aggressive. She had both doses and had no symptoms, but 92-year-old female had no symptoms right away, other than normal body aches and pains, but the next day was high as a kite. Her son has heart disease and she advised him not to take it right now. They were losing a lot of people to the vaccine in nursing homes, no further information provided. This could be affecting good hearts more than damaged hearts, read that this virus likes to work in parts of the body that are already damaged. The outcome of event diarrhea was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, a causal association between the reported angina and BNT162B2 cannot be completely excluded. Note however, that the patient has underlying angina with some stents that may also have contributed to the event. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
72 2021-02-23 blood pressure increased Elevated high pressure, nauseas, dizziness and strong headaches. Couldn't sleep well.
72 2021-02-23 loss of consciousness Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pa... Read more
Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pass out." Patient had not eaten since yesterday. Given orange juice. Patient began experiencing slight altered mental status (appeared to be losing consciousness in-and-out). EMS treating patient and transported patient to ED.
72 2021-02-23 blood pressure increased high blood pressure and flushed; 152/90
72 2021-02-24 chest discomfort Chest tightness and shortness of breath
72 2021-02-26 hypertension, palpitations Sever shortness of breath, palpitations, HTN (200s systolic)
72 2021-02-28 nosebleed, chest pain I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in gener... Read more
I ache all over, have no energy my chest hurts, bloody nose, sweating, fever and chills.... in general I feel like I have been poisoned.
72 2021-02-28 loss of consciousness Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous re... Read more
Passed out; Constant running nose; Cough; bad cough; Sore throat; Diarrhea; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received the second of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9267, Expiration Date May2021, via an unspecified route of administration on 08Feb2021 (at the age of 72 years old) as SINGLE DOSE in the left arm for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Historical information included BNT162B2 dose 1 for COVID-19 vaccination.The patient developed the sore throat on 09Feb2021, Cough; bad cough on 10Feb2021, constant running nose on 11Feb2021. On 11Feb2021, the patient passed out in the bathroom floor, had an ambulance here. Patient still coughing a little, not as badly. The patient experienced diarrhea in Feb2021. Treatment for all events included cetirizine (ZYRTEC), Triamcinolone (NASACORT), pseudoephedrine (SUDAFED), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL). Outcome of the events Passed out, Sore throat, Constant running nose, Diarrhea was unknown. Outcome of the events Cough; bad cough was not recovered
72 2021-02-28 chest pain chest pain; This is a spontaneous report from a contactable consumer. A 72-year-old female patient r... Read more
chest pain; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) on her left arm, via an unspecified route of administration on 25Jan2021 at a single dose for covid-19 immunization. Medical history included Open heart surgery in 2006. There were no concomitant medications. It was reported that the patient had the COVID shot on the 25Jan2021, she and her husband, and she sat for 20 minutes, everything was fine, she got in the car, and was going down the road, she had chest pains, then it eased up and it stopped then probably another 25 to 30 minutes later is started again. The chest pains started probably a half hour after the shot. They went away, then she had it three times that day, and once today, and once yesterday, so they are ongoing. The outcome of the event was not recovered.
72 2021-03-01 chest discomfort, chest pain Intermittent Tightness and Pain in Chest still 24 occuring 24 hours after injection.
72 2021-03-01 oxygen saturation decreased Oxygen level dropped to 85. (normally 95)
72 2021-03-02 palpitations ? PALPITATIONS pt getting vaccine this afternoon. +palp post-injection, denies CP/SOB/dyspahagia... Read more
? PALPITATIONS pt getting vaccine this afternoon. +palp post-injection, denies CP/SOB/dyspahagia, AOx4, fsbs=119 Patient was released after observation
72 2021-03-02 heart rate decreased Resting heart rate was 122. Decreased to 95 by 11:30. Normal next morning.
72 2021-03-03 platelet count decreased 2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, ... Read more
2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, with fever & brain fog, & felt very weak, & I had a swollen & sore lymph node under my arm. On day 6 my upper are (& underneath) turned red & swollen. I also had been suffering random itching. On day 8 I went ER, & was given steroid cream. That night most of my back turned red. I put the cream on & it was gone next day, but my arm stayed red & itching. All this has made me weaker, & My stomach hasn?t felt good.
72 2021-03-03 lightheadedness, hypotension Pt received her first dose Pfizer Covid 19 vaccine and was currently being monitored in the observat... Read more
Pt received her first dose Pfizer Covid 19 vaccine and was currently being monitored in the observation area for 30 minutes when she developed vasovagal symptoms- diaphoresis, near syncopal episode and hypotension. EMS and nurses responded with the event. initial BP = 90/40. Pt was transferred immediately to the treatment room, was placed on supine position and was further monitored. Pt relates she has these symptoms every time she has her blood drawn. Repeat BP=106/56 after 5 mins. Pt became better after 15 mins, BP=127/68, pulse ox=98 RA, pulse=70.
72 2021-03-04 hypertension Hypertension and lightheadedness. No other symptoms. Likely not related.
72 2021-03-06 chest discomfort Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got bette... Read more
Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got better Saturday but then same symptoms returned Saturday night and continue today, joint pain, muscle pain
72 2021-03-07 blood clot Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; C... Read more
Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Questioned if she might have a blood clot in left leg; Might have an infection in area of cellulitis in left leg; pain in the left leg; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, expiration date 31May2021), via an unspecified route of administration on 01Feb2021 at left upper arm around 19:00 or a little later at single dose (at the age of 72-years-old) for covid-19 immunization. Medical history included bad knees and got injections for this and recurrent cellulitis of legs (cellulitis was not active at time of vaccine; but anytime her leg swells with bad knees she had a little episode with the cellulitis down around her ankles on both legs but left leg was more predominant. She had been keeping it at bay), mineral supplementation, bad knee pain, blood pressure medication (abnormal), urine output control (abnormal), dehydrated and dizzy. Concomitant medication included lisinopril as blood pressure medication, potassium for Mineral supplement, solifenacin succinate for urine output control, paracetamol (TYLENOL 4) for bad knee pain. She had taken potassium before and it calmed it down: she was little dehydrated, little dizzy, so was drinking some Pedialyte, water, and taking potassium. The patient had it once before but it kind of snuck up on her again. The patient called to ask if anyone had reported any type of blood clot on the same side of the body that the Pfizer COVID-19 Vaccine was administered. She questioned if she might have a blood clot in her left leg after having been administered the Pfizer COVID-19 Vaccine. She had recurrent cellulitis in both legs prior to Pfizer COVID-19 Vaccine. The doctor thought the cellulitis in left leg may be acting up and that she might have an infection in that area of cellulitis. She reported pain in the left leg when she rested her leg on a pillow; but did not feel any pain when she was standing and walking. The pain became a little too hard for her to bear so the doctor prescribed her Cephalexin 500m capsule every 12 hours-she was on the 3rd capsule now. Onset date for the events was approximately 03Feb2021 or 04Feb2021. The events were better since started Cephalexin. Second dose date scheduled for 22Feb2021 but did not give her time. The outcome of the events was recovering. Follow-up (23Feb2021): New information received from the product quality complaint group includes confirmation of lot number (EL9262) and new expiry date.
72 2021-03-07 nosebleed Patient got her first Pfizer COVID-19 vaccine around 1:00pm on 3/8/21. She returned to the pharmacy... Read more
Patient got her first Pfizer COVID-19 vaccine around 1:00pm on 3/8/21. She returned to the pharmacy around 2:00pm and stated that her nose would not stop bleeding. She continued to bleed for 10 minutes. Patient was pinching her nose for the entire time, and ice was applied. She did not complain of light-headedness or dizziness. After her nose continued to bleed, the paramedics were called to evaluate the patient. The paramedics arrived and took her blood pressure. Her blood pressure was 201/94. The patient stated that she did not take her blood pressure medications today because she was getting the COVID vaccine. She stated that she did take an aspirin today. The paramedics took the patient to the hospital.
72 2021-03-08 chest pain Pain in left arm, across back and right shoulder, chest pain, headache, very cold, and severe weakne... Read more
Pain in left arm, across back and right shoulder, chest pain, headache, very cold, and severe weakness. It lasted about 4 hours, from 9am to 1:15pm.
72 2021-03-08 skin turning blue Woke up with Bright Blue Palms on second treatment. ON first treatment had swollen lymph nodes
72 2021-03-09 heart rate increased Four hours post injection I became flushed and broke out in hives and a red itchy rash on my body an... Read more
Four hours post injection I became flushed and broke out in hives and a red itchy rash on my body and legs. My heart rate jumped at the same time. I took Benadryl immediately, and for the next 24 hours. The itchy rash has persisted on and off ever since ( 6.5 weeks). In addition I have had many other symptoms. Excessive hair loss, a severe metallic taste in my mouth that is getting worse over time. At the suggestion I was scratch tested for PEG (negative), but I have since learned that test is not reliable. I tried to go on a sustained course of antihistamines but got allergic reactions to both 24 hour Allegra and 24 hour Claritin. My primary care doc has me on a course f very high dose vitamin C and I am getting some relief, but if i don't take the vitamin the itching returns.
72 2021-03-09 palpitations, chest discomfort Immediately upon leaving the COVID shot parking lot at Hospital, I began to feel pain shooting down ... Read more
Immediately upon leaving the COVID shot parking lot at Hospital, I began to feel pain shooting down my arm all the way to my fingertips. Then I started to feel disoriented. Then, as I was driving myself home, I felt constriction in my chest, like I was barely holding onto consciousness, then pain shooting up my shoulder into the left side of my neck, the left side of my face, my left eye and into the left side of my head. My heart was pounding, my head was hurting intensely and I wondered whether I was having a stroke while trapped in stop and go traffic. The intense pain continued while I drove, for about 30 minutes. Then it subsided somewhat -- but continued through the evening. I could not get to The pain continued in my arm, up the left side of my body and into my head all night. I could not sleep. My heart was pounding. Somehow I dozed off around 2 or 3am. The next day I felt groggy and tired, with the more moderate pain continuing in my arm and all the way to my hand. Finally, on Monday morning, I was able to reach my doctor's office. I was told to go the ER, which I did. They could find nothing "emergent." The pain, tiredness and headaches continued through Thursday. Friday I started to feel better -- a week after the shot on Saturday, 2/27.
72 2021-03-09 blood pressure increased On 2/26/2021, I had a soaking night sweat and a few other symptoms. After 72 hours, (3/1/2021) labi... Read more
On 2/26/2021, I had a soaking night sweat and a few other symptoms. After 72 hours, (3/1/2021) labile blood pressure rose; lymph nodes left neck, breast and spleen were enlarged and tender;pain/tenderness cont'd down left side lymph nodes. General ache and pressure across back (kidney area). After 2-3 days, lymph nodes on right side became tender. Labile blood pressure requires medication (generic norvasc) but still fluctuates. Pain in joints and slight "bloating" overall. Sinus mucosa completely dry (nasal). These symptoms continue as of 3/9/2021.
72 2021-03-09 fainting, hypertension in less than a minute I had a vasvagal syncope response and my blood pressure got so high that the m... Read more
in less than a minute I had a vasvagal syncope response and my blood pressure got so high that the machine couldn't take it--in the 200's/100 something. I was taken to the ER and monitored for a few hours and labs. BP came down slowly, but not perfect. I was released around 7pm. Event happened at 3:46pm. The next day I had chills first, then I had a slight fever, a terrible headache in the back of my head, dizziness and night sweats. By the 2nd day after I am feeling better.
72 2021-03-10 heart rate increased, haemoglobin decreased After first Shot: First day: headache, slightly sore arm , achy, fatigue Next few days: elevated hea... Read more
After first Shot: First day: headache, slightly sore arm , achy, fatigue Next few days: elevated heart rate 1 week after shot: even higher heart rate, pain when breathing, pain in chest and right shoulder, extreme fatigue After second shot: Shortness of breath, pain with breathing,fast heart rate, extreme fatigue, achy
72 2021-03-10 loss of consciousness Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; no... Read more
Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; non-amblitory, could not support weight, major balance issues. Televisit 1/26/21=earache. Blacked out cold 5 min, non responsice 30 min 2 am 1/26/21; woke with Bell's Palsey; Ddumb televisit 1/28/21=BP. Urgent Care visit-EKG (normal), bloodwork, urine lab work. 2/1/21 Saw NEURO = MRI brain w/contrast to rule out cancer (2/4/21; Two weeks of solid hallucinations 24/7. Horrendous balance issues-almost non-amblitory from onset 1/26/21 to present. Lost 9 pounds in 2 weeks.(I was 104 now 95 pounds). I was walking 5 mi a day, walked 1/24/21, healthy. Devastating pain to left side of head/face, esp ear. PAIN
72 2021-03-10 blood clot blood clots dx'd via ultrasound on 2-20-21
72 2021-03-11 fast heart rate, heart rate increased Extreme overall muscle pain, tachycardia, rapid heartbeat constantly lasting over 24 hours
72 2021-03-11 heart rate irregular, heart rate increased My heart went into A-fib, rapid irregular heart beat and racing pulse (132) started 5 hours after s... Read more
My heart went into A-fib, rapid irregular heart beat and racing pulse (132) started 5 hours after shot. Called Cardiologist next day about 1:30 pm after taking morning daily medicine did not relieve the symptoms. Dr advised to double my Metoprolol med and if that did not help to go to the emergency room.. About 2 hours later my A-fit symptoms stopped and my pulse was back to normal.
72 2021-03-11 fainting muscle stiffness during morning walk, nausea while eating cereal, stood up and fainted some nausea w... Read more
muscle stiffness during morning walk, nausea while eating cereal, stood up and fainted some nausea while on floor for 2.5 hours sleeping three hours later
72 2021-03-13 chest pain Chest pain (5/10), bilateral jaw numbness, left back pain, and headache. Oxygen 6 liters. Taken to t... Read more
Chest pain (5/10), bilateral jaw numbness, left back pain, and headache. Oxygen 6 liters. Taken to the ED>
72 2021-03-14 blood clot, deep vein blood clot Developed a DVT blood clot in right leg calf area -after the shot-
72 2021-03-15 pallor, hypertension I am reporting the below as everything written has NEVER happened to me before in my 72 years of liv... Read more
I am reporting the below as everything written has NEVER happened to me before in my 72 years of living. This has all taken place since I have had the Vaccine Injection on Wednesday, February 24th. I am attributing all of this as a possible reaction to the vaccine or maybe coincidence. I wanted to report what has taken place so you all can assess if this is a possible adverse reaction, a direct effect from the vaccine or just coincidence. Please let me know if anything like this has been reported and what your thoughts about the matter. Wednesday, February 24th 11:15am Pfizer Vaccine right arm ?about an hour later discomfort on shot side that went from the shoulder up the right side of the neck. Was gone by next day. Thursday, February 25th Day seemed to be normal. When I went to bed that evening a pressure and pounding on the left top side of the head, on the part line. Lasted 5-6 hours and then went away for that episode. Friday, February 26th Day started off OK, walked 2 miles and then ran some errands. *3:00pm I bent down to pick up something and when I came up I had extreme light headedness like I have never had before. I was able to get myself collected and then continued to get ready to go out. *6:00pm I just sat in a chair in the restaurant and BAM the room started spinning at about 500 miles (that is the speed that it felt like) an hour. My arms were flailing as I was trying to grab something to old onto. Just when I was about to fall off of the chair my husband walked up and grabbed me as he could see that something was going on and he said that I was white as a sheet. Once I got somewhat collected, I knew immediately that I had to throw up. My husband took me to the restroom. I had severe dry heaves that just would not stop. I wasn?t breathing properly so my hands and feet were numb, tingly and very white in color. Then I had to have a bowel movement. We phoned for the ambulance to take me to the hospital jus to make sure that I did not have a stroke, or it was my heart, or a vessel had burst in the head. The Paramedic tested me for a stroke and I passed the test. *8:00pm or so I had another episode with room going around at top speed and I started having dry heaves. Nurse gave me medicine in the IV for nausea. My Doctor said that everything was Benign. He said that the CT patient scan was negative and all other tests were OK. Saturday, February 27th I was released from the hospital and went home. I did very little that day. I slept that night from 10:00pm until 10:00am the next day. Sunday, February 28th I was lightheaded, had a headache, and ears ringing all day. I just did not feel myself at all. Tuesday, March 9th Around noon I had a severe lightheadedness/spinning episode, eyes felt like they were spinning. Laid down for about 2 hours and when I got up I was able to function and the spinning had gotten better. Headache all night long, ears ringing, feeling of lightheadedness. Wednesday, March 10th Not quite as dizzy, headache all day, back of neck and left side of head sore to touch. Pounding on left top side of head ? along the part line, where I had the same discomfort the 2nd day after the vaccine. Thursday, March 11th Having discomfort on left side of head. To the right of the left ear, going down to the neck. I can touch those areas and add to the discomfort. Friday, March 12th On Monday, March 7th I noticed a red spot on the right side behind where I was given the injection. I tried to treat it myself but my remedies were not helping. Contacted my Dermatologist on Thursday, March 11th. She saw me today, Friday, March 12th. She is not sure if it is a possible aftermath of the vaccine or something else. Had some bloodwork run to rule how Shingles. Prescribed some medication for Shingles to take until Monday when the bloodwork report is due for review. Blood work was negative for Shingles. Ever since the episode on February 26th I have NOT felt myself at all. Lightheaded, nausea, headache, pressure in head and feels heavy, not steady on my feet, discomfort in back of head near neckline, on/off discomfort in the top of the head with a pounding force. BLOOD PRESSURE IS NOW HIGHER THAN NORMAL ESPECIALLY WITH BOTTOM NUMBER BEING HIGH. I have never had a Blood Pressure problem, although as I have aged the top number has elevated but not enough to take medicine. However, the lower number is now elevated (high 80-?s, low mid range 90?s) and Cardiologist is going to make a decision on whether I should start on a low dose medicine. I am to take my 2nd Pfizer shot tomorrow ? Wednesday, March 17th at 11:00am. Thank You for reviewing the above writings. I look forward to the conclusion VAERS makes on my situation.
72 2021-03-15 transient ischaemic attack Patient reported have a slight left sided mouth droop on 3/8/2021- went to ER states EKG, CXR, and C... Read more
Patient reported have a slight left sided mouth droop on 3/8/2021- went to ER states EKG, CXR, and CT of head all negative. Kept overnight and had MRI 3/9/2021 in AM revealed "mini stroke" TIA per neurology. She was discharged with Plavix and Lipitor. Has follow up appointment with neurologist 4/8/2021 and cardiologist 4/1/2021. Patient states she was on Amiodarone and Bystolic prior to having this TIA. Patient is scheduled for second dose of vaccine 3/19/2021 and wants to receive it. She is cleared to receive from our stand point. Please reach out via email or phone if you guys disagree.
72 2021-03-16 atrial fibrillation, chest discomfort Afib,5hours in length on Tues March 10th BP at 176/89 on Wed at home and Thurs at Dr's office Ongoi... Read more
Afib,5hours in length on Tues March 10th BP at 176/89 on Wed at home and Thurs at Dr's office Ongoing in up and down cycles: chills,tight chest,foggy brain,bronchial cough with thick mucous ,some green, intense sneezing, nausea,diarrhea, Today,Wed March 17th very slow brain function low fever,diarrhea,very tired,hard to focus, less sneezing,no green mucous in cough.
72 2021-03-16 blood clot Pain in calf of left leg. Two blood clots lower left leg, being treated with blood thinner Xeralta
72 2021-03-17 blood clot, pulmonary embolism Developed severe back pain. which she went to the ER to have evaluated. Upon evaluation, she was di... Read more
Developed severe back pain. which she went to the ER to have evaluated. Upon evaluation, she was diagnosed with a PE and blood clots in her spleen
72 2021-03-17 blood pressure increased Pt received vaccine at 09:52. 10:22 pt started to itching on arms and back. No visible rash. No ches... Read more
Pt received vaccine at 09:52. 10:22 pt started to itching on arms and back. No visible rash. No chest pain, stridor, sob, tongue or lip swelling. Hx of allergies to pcn, iodine, sulfa, latex. Hx of rash and itching with pneumonia shot. No hx of anaphalxis to vaccines or meds - just itching and rash. VSS . 98 % RA 68. BP 177/84 (pt did not take her BP medication as of this mornig). Pt states she feels well but still itching as of 10:41. Pt appears to have the ability to make her own decisions and would like to talk to husband about going to ER. If pt still itching, recommend pt be evaluated. Pt would like d/w husband and physician prior to going to ER. EMS crew on standby. Note from ED: This is a well-appearing and pleasant 72-year-old female who presented via ambulance for itching response after receiving the Pfizer COVID-19 vaccine today. Patient is very well-appearing. Skin is normal and well-appearing there is no rash or erythema. Patient is speaking in complete sentences with normal work of breathing. Respirations are even and nonlabored. Lung fields are clear to auscultation bilaterally throughout patient denies any shortness of breath or breathing issues, cough or itchy throat. Airway is clear with no tongue or mouth swelling, floor mouth is soft and not elevated mandible is easily palpated, throat is nontender, neck is supple. Heart rate is within normal limits with regular rhythm. She was provided with Benadryl and famotidine as treatment for her itching. Patient was observed for greater than 2-1/2 hours in the emergency department. Patient noted that itching markedly reduced with use of Benadryl I felt patient was appropriate and stable for discharge. I had an in-depth discussion with her regarding she monitor her symptoms closely at home we discussed all symptoms that she should look for that would be concerning and she should make sure to seek emergent care. She was given the opportunity ask questions. All question concerns were thoroughly addressed. Patient indicated she felt good with her care here today with discharge and would monitor herself at home. She was picked up by her husband would also be home to monitor her. Advised her to follow-up with her primary care provider regarding recommendations for whether she should receive her second dose of the vaccine. Provided her with CDC printed out recommendations for vaccine allergic reaction. She was given the opportunity ask questions. All questions and concerns were addressed and answered to the best of my ability. No evidence of Stevens-Johnson syndrome, anaphylaxis, cellulitis, or systemic compromise Feel supportive care and symptomatic treatment reasonable. Urged dermatologic follow up. At time of discharge patient remained well-appearing not in any type of acute distress. She ambulated out of the emergency department with a steady gait. I reviewed recent and relevant Chart Entries, Previous Notes, Previous Labs, Previous Radiology studies.
72 2021-03-19 heart flutter Minor chest fluttering few minutes after shot. Later that day, yesterday and less today dizziness, w... Read more
Minor chest fluttering few minutes after shot. Later that day, yesterday and less today dizziness, weakness, stumbling, few words not coming out quite correctly. These challenges seem to be improving. Tiredness, headache, unwell feeling, arm pain, fever.
72 2021-03-19 fainting, heart rate increased Within a few minutes, felt faint, unwell, did faint, came to, hot and sweaty, retching, heartbeat 11... Read more
Within a few minutes, felt faint, unwell, did faint, came to, hot and sweaty, retching, heartbeat 110.
72 2021-03-19 arrhythmia arrhythmia (skipped heart beat) lasting 3 minutes
72 2021-03-21 chest pain, chest discomfort Patient developed some chest pain heaviness in her left chest area. The pain was worse with a deep b... Read more
Patient developed some chest pain heaviness in her left chest area. The pain was worse with a deep breath She took 6 baby aspirins prior to coming to the ER - did not help with the pain She rec'd Nitroglycerin SL and Tylenol 650mg. Cardiac enzymes were negative X 2. D-dimer was negative. Patient was discharged without any further incidents
72 2021-03-21 heart rate decreased, loss of consciousness, pulse abnormal Pt. became unconscious and lost bladder control-she had shallow, infrequent respirations with an exp... Read more
Pt. became unconscious and lost bladder control-she had shallow, infrequent respirations with an exp. stridor noted-pulse faint and slow. Epinephrine given IM per clinic standing order and pt. became conscious within 15 seconds-could not remember losing consciousness. Taken to the hospital for further evaluation.
72 2021-03-21 lightheadedness altered mental status, weakness, presyncopal. Evaluated by EMS-Transported to Emergency room/departm... Read more
altered mental status, weakness, presyncopal. Evaluated by EMS-Transported to Emergency room/department or urgent care.
72 2021-03-21 pulmonary embolism she was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had ... Read more
she was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots).; she was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots).; she was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots).; This is a spontaneous report from a contactable Nurse. A 72-year-old female patient (Reporter's mother, not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension (HTN), hyperlipidemia and high cholesterol. The patient's concomitant medications were not reported. No other vaccine in four weeks. 2 weeks after the immunization, 06Feb2021 the patient was hospitalized with pulmonary embolism and they also found blood clots in her spleen (she had both venous and arterial clots). Follow up with hematologist after discharge, MD reported unable to determine cause of clots. AE resulted in Emergency room/department or urgent care, Hospitalization. The patient hospitalized for three days. The patient received treatment blood thinners. The patient tested Covid post vaccination on 06Feb2021 with negative result. The outcome was Recovered with Sequel. Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
72 2021-03-22 atrial fibrillation Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose star... Read more
Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose started and continues until now. It decreased after dermatologist perscribed medication. On 3/13 went to hospital with severe chest pain. They determined it was muscular-sceletal. While in the hospital and to this day has burning in bottoms of feet. Has weakness and numbness in both legs and feet. The weakness decreases ability for activity- very uncomforatable and making her unsteady when up. She also has some weakness in her arms.
72 2021-03-22 chest pain Patient received her first Pfizer dose with no problems. She came back at her scheduled appointment ... Read more
Patient received her first Pfizer dose with no problems. She came back at her scheduled appointment for the second dose of Pfizer. She initially did well, but after 30-40 minutes the patient came back to the pharmacy complaining of chest pain and felt her throat was tightening up. She felt it was from the vaccine and not from any other reason. I asked her if I could call a paramedic and she declined. I asked about calling a family member/ friend and she also declined. I gave her 5ml of liquid Benadryl and asked her to continue sitting in the pharmacy. After apx. 10-15 minutes she stated she was starting to feel better. I checked on her every few minutes and kept her in my view the entire time. After apx. 30 more minutes she stated feeling a lot better and wanted to go home. I again offered to call someone or call paramedics and she adamantly refused. I gave her some additional Bendadryl to take home with instructions to take 5 ml every 4 hours for the rest of the day. She left the store. After a apx. 5 minutes a technician went out to see if she had left. She spoke to the patient in her car and patient stated she was fine and heading home. She stated she could drive b/c she only lives a couple minutes from the store. I called the patient at home later that night to check on her and she stated feeling fine, and thanked me for checking on her.
72 2021-03-22 cardiac arrest Pt recieved 1st Pfizer vaccine on 2/25/21 and her 2nd one on 3/18/21 Pt went to the ER on 3/23 via 9... Read more
Pt recieved 1st Pfizer vaccine on 2/25/21 and her 2nd one on 3/18/21 Pt went to the ER on 3/23 via 911 in full cardiac arrest Per daugher, she c/o lightheaded this A< she came out of her room snad fell down, was vomitting and labored breathing paramedics were called, she went to Hospital and later died
72 2021-03-23 blood glucose increased Got the vaccine, got very dizzy immediately after and kept her for 30 minutes and gave her water. ... Read more
Got the vaccine, got very dizzy immediately after and kept her for 30 minutes and gave her water. Then driving home she started feeling itchy, and could feel little hives in each ear. She was then very lethargic that night and all the next day Sunday, and then first thing Monday morning was covered with a large hives and a rash. She was covered from one end of her body to the other and into her joints where she was not able to bend her joints. She tried to use cortisone, but that made it worse. Also tried Benadryl lotion and Calamine lotion, which also did not help. She then went to the doctor and he prescribed steroids. She has had pain as if somebody was sticking needles in her. In the past 2 days her lips are numb and swelled, and on the right cheek plus her two eyes there is a big swollen area and her eyes are burning. Now her entire body is peeling as if she had a bad sunburn. Now her blood sugar due to the steroids is from 250-475. The site of the vaccine itself was ok.
72 2021-03-23 blood pressure increased Patient received the Covid-19 vaccine. Patient notified the observation RN that she felt that her h... Read more
Patient received the Covid-19 vaccine. Patient notified the observation RN that she felt that her hands were beginning to swell. I was called over and brought patient to the observations area. Patient had no c/o of shortness of breath, tightness in the throat or chest, or swelling of the lips, tongue, or face. She was able to remove her rings without issue. Treatment/intervention - Initial VS were as follows: 1700 HR 94, BP 183/87, O2 Sat 98% Patient was given 50mg of benadryl orally. Subsequent VS: 1710 HR 88, BP 177/80, O2 Sat 99% 1719 HR 90, BP 152/92, O2 sat 98% Patient reported that her BP was elevated, but it was coming down. She reported no further increase in swelling and that she was feeling better. She was observed for a total of 45min. She was instructed to consult with her MD and then schedule her second dose once given the ok.
72 2021-03-23 ischemic chest pain, palpitations my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started ... Read more
my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started feeling stuffy; felt flushed; my face was red; what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain; what feels like my heart quivering for several seconds; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at left arm on 08Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included gastroesophageal reflux disease, osteoarthritis, nodules on thyroids and allergy to Aspartsme. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40). the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took Sulfanomide (Sulfa drugs) and had allergy (swelling), codeine and had allergy (nausea). The symptom that has made patient concerned enough to report the possibility of a side effect is: she had her shot this morning and between about 8:55 and 9:15 this evening she had 9 or 10 episodes of what feels like her heart quivering for several seconds followed 3 or 4 times by very slight pain, just below her right breast, she has never experienced such a thing before. (she took baby aspirin around 9:20 in case she was having some kind of heart thing). It's 9:45 pm, and the quivering episodes haven't happened for the last 30 minutes, so maybe they're all cleared up. Earlier, within 30 min of getting the vaccine, her ears started feeling like they were stopped up and her nose started feeling stuffy. Then as she was driving home she felt flushed and looked in the mirror and her face was red, she took one Sudafed in case it was allergies, and those symptoms improved quite a lot. Adverse event start date was 08Mar2021 10:00 AM. Since the vaccination, the patient has not been tested for COVID-19. Unknown if treatment received for ears started feeling like they were stopped up and nose started feeling stuffy. Outcome of what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain was recovered. Outcome of felt flushed and face was red was recovering and outcome of other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
72 2021-03-24 blood pressure increased After the 15 min waiting period the patient was feeling very faint and - almost fell twice while sta... Read more
After the 15 min waiting period the patient was feeling very faint and - almost fell twice while standing up. She had an elevated blood pressure and was said was short of breath. We took her blood pressure, had her sit in front of the pharmacy so we could monitor her until her son came and picked her up. Just talked to her on the phone and she is doing fine.
72 2021-03-24 cerebrovascular accident Aphasia & right sided weakness. CVA.
72 2021-03-24 low blood oxigenation Persistent hypoxemia as well as intermittent cough and sputum production along with shortness of bre... Read more
Persistent hypoxemia as well as intermittent cough and sputum production along with shortness of breath , required hospitalization.
72 2021-03-24 atrial fibrillation two migraine headaches - atrial fibrillation; two migraine headaches - atrial fibrillation; This is ... Read more
two migraine headaches - atrial fibrillation; two migraine headaches - atrial fibrillation; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration in the left arm on 07Mar2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included warfarin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); both taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 10:00, the patient experienced two migraine headaches and atrial fibrillation. It was unknown if the patient received any treatment for the events. The clinical outcomes of the two migraine headaches and atrial fibrillation were recovered in Mar2021.
72 2021-03-25 blood pressure increased "Pfizer-BioNT Covid-19Vaccine EUA" Because I am allergic to Hornet sings I waited 30 mins after the ... Read more
"Pfizer-BioNT Covid-19Vaccine EUA" Because I am allergic to Hornet sings I waited 30 mins after the injection. I was fine so I walked out to my truck. I became flushed in the face and my mouth had a metallic taste so I walked back into the clinic to tell them. They took my Blood pressure which was 200/125. I felt very off so they wheeled me into Urgent Care where they gave me one benadryl and monitored my blood pressure. They then called for ambulance for ER . I was released when my blood pressure was lower. I will not get the second injection of Pfizer!
72 2021-03-25 chest pain After 1st shot had 8 days of a migraine and vertigo every day. Then after second shot 3 weeks later... Read more
After 1st shot had 8 days of a migraine and vertigo every day. Then after second shot 3 weeks later, had 11 out of 12 days of migraine and after 8.5 days after shot had a whole body rash for 4.5 days . I have had vertigo most every day since the last shot on 2/20 and have had 27 migraines since the 1st shot Jan 30th I used Hydrocortisone on the itchy, blistery rash. Not much sleep for 3 nights. The night before the rash popped out I experienced chest pain that I thought was heartburn but was not relieved with baking soda and water and charcoal pills. It didn't go away until the hours into the next day and the rash was there at 3am. I have had Migraines for many years but this is 4 times more migraines.
72 2021-03-25 palpitations Chills - started within an hour Sore muscles and joints - 2 hours Palpitations - 12 hours Fever - 24... Read more
Chills - started within an hour Sore muscles and joints - 2 hours Palpitations - 12 hours Fever - 24 hours Rash - 48 hours
72 2021-03-25 chest pain, heart attack Severe chest, back pain starting 1 1/2 hrs after injection, culminating in mild heart attack early W... Read more
Severe chest, back pain starting 1 1/2 hrs after injection, culminating in mild heart attack early Wednesday a.m.
72 2021-03-27 heart rate abnormal I received my vaccine at 10:15 am on March 18, 2021, and was fine until 6 pm that evening.After eati... Read more
I received my vaccine at 10:15 am on March 18, 2021, and was fine until 6 pm that evening.After eating dinner, I took my omesartan and pravastatin, as usual, and within 10 minutes, my heart rate became erratic. I have tachycardia (SVT) but control it with atenolol. I went to the ER at where I had an EKG, ches xray, and blood work. My heartbeat reached 143. While waiting on the test results, I noticed a rash forming below both my knees. The ER doctor returned with the news that all tests came back normal with no accounting for the rapid heart beat other than the Pfizer vaccine. He checked the rash saying it was likely another reaction from the vaccine. He gave me medication to reduce my heart rate, prescribed hydrocortisone for the "rash" and released me. By the next morning, my heart rate was back to normal but the "rash" had spread all over both legs. On Saturday, March 20,, 2021, I went to a medical clinic to see if I could Triamcinolone Acetonide on the rash as the hydrocortisone wasn't helping. The NP identified the rash as petechiae and prescribed Triamcinolone. She could not prescribe an oral steroid xplaining that not enough info is known about the Covid vaccines and possible interactions with steroids. I then followed up on Monday, March 22, 2021, with my PCP who said I had a bad case of petechiae and did more blood work to rule out vasculitis. The day before getting the vaccine, I competed a 7-day course of the antibiotic Nitrofurintoin for a UTI and suggested to her that perhaps I had a delayed reaction to it. However, she ruled that out saying I would likely have had a reaction before the day after completing the medication. She called me back the next evening on Tuesday, March 23 advising that all blood work came back negative, that the Pfizer vaccine is likely the cause of the petechiae, and that I should probably not get the 2nd vaccine. I asked her if she thought I would be okay getting the Johnson & Johnson vaccine and she said yes, if they will give it to you. I could not get directed to anyone to answer that question, but I need to know. Can you help me?
72 2021-03-28 palpitations Racing Heart/patient felt flush
72 2021-03-28 atrial fibrillation new onset atrial fibrillation
72 2021-03-29 chest pain, pulmonary embolism, blood clot BLOOD CLOTS : Two days after receiving Pfizer dose 2 my mother had difficulty breathing and had che... Read more
BLOOD CLOTS : Two days after receiving Pfizer dose 2 my mother had difficulty breathing and had chest pain. She was hospitalized for six days due to blood-clotting in the lungs.
72 2021-03-29 cerebrovascular accident mini stroke or seizure; mini stroke or seizure; pinched nerve; left arm was weak, numb, cold; left a... Read more
mini stroke or seizure; mini stroke or seizure; pinched nerve; left arm was weak, numb, cold; left arm was weak, numb, cold; left arm was weak, numb, cold; a fine tremor on extension of my arm; This is a spontaneous report from a contactable other hcp (nurse and patient). A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:45 (Batch/Lot Number: EN6198) as SINGLE DOSE (at the age of 72 years) for covid-19 immunisation. Medical history included partial seizures, autoimmune thyroiditis, eczema, osteoarthritis, asthma, irritable bowel syndrome, carpal tunnel syndrome from an unknown date and unknown if ongoing 10 years ago. The patient is not pregnant, and the patient did not have Covid prior vaccination. Concomitant medication included phenytoin (DILANTIN) taken for seizure, start and stop date were not reported; levothyroxine sodium (SYNTHROID); ergocalciferol (VIT D) and unspecified vitamin. The patient previously took amoxicillin and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity, azithromycin and experienced drug hypersensitivity. The patient experienced mini stroke or seizure on an unspecified date with outcome of unknown, left arm was weak, numb, cold and a fine tremor on extension of arm on 03Mar2021 14:45 with outcome of recovered. On 06Mar2021, patient woke up and left arm was weak, numb, cold and she had a fine tremor on extension of arm. Symptoms resolved after 45 minutes but returned within 30 minutes and lasted another 45 minutes. No treatment was received for left arm was weak, numb, cold and she had a fine tremor on extension of arm. Patient called doctor, spoke to the advice nurse and was advised to go to the ER (emergency room) now. Patient did deep breathing and relaxation, symptoms resolved, and did not go to the ER. Instead spoke with a doctor and agreed to go to the ER if symptoms returned. Patient also had a video visit with primary doctor, and she was advised to take baby ASA. The Doctor said it could be a pinched nerve on unspecified date with outcome of unknown. Symptoms have not returned. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Mar2021. The case was reported as non-serious.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the CVA and other events. The reported events likely represent intercurrent medical conditions. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, EEG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
72 2021-03-30 skin turning blue had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylacti... Read more
had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; pain in abdomen and face/Abdominal pain; pain in abdomen and face; Generalized pruritus with skin rash; Respiratory distress; Angioedema (not hereditary); a lot of pain after her tooth extraction; Upper airway swelling; Cyanosis; Hoarse voice; Difficulty breathing; Sensation of throat closure; Generalized urticaria (hives); Generalized erythema; Generalized pruritus with skin rash; Localized injection site urticaria; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6199) (at the age of 72 years old) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD); osteoarthritis; rheumatoid arthritis (RA); allergy: Environmental; asthma. Concomitant medications included ubidecarenone (COQ10 [UBIDECARENONE]) ongoing; atorvastatin ongoing; nebivolol hydrochloride (BYSTOLIC) ongoing; methimazole ongoing. The patient was taking some medications prior to the event being reported. No prior vaccinations (within 4 weeks). The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than bnt162b2 prior to the event being reported. The patient had not received any other vaccines around the time of bnt162b2 vaccination. Caller would like to know if there was an impact on efficacy if she chooses to take her second dose of the Pfizer BioNTech COVID-19 vaccine at a later date than the recommended 21 days. Caller received her first dose of the Pfizer BioNTech COVID-19 vaccine on 03Mar2021. She stated that on 08Mar2021 she had a tooth extraction and was told by her physician to take Advil. Then on 11Mar2021 caller reported that she had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days. She stated that her physicians were unsure if it could have been a delayed reaction to the vaccine or a reaction to the Advil (which caller stated she had taken all her life) (lot number: 55633, Expiry Date: Feb2023). Caller was scheduled to receive her second dose of the vaccine next week and would like to know if she should take it. She stated one physician told her it was okay to do so while another told her to hold on taking it, so she was confused as to what to do. Reporter seriousness for Anaphylactic reaction was Hospitalization. The patient was in hospital for Anaphylactic reaction from 11Mar2021 to 14Mar2021. The patient stated she received her first COVID vaccine on 03Mar2021, and on 08Mar2021, she had a tooth extracted. Because of that, she was taking Advil on 11Mar2021, she had an anaphylactic reaction to the Advil and an acute hepatitis. And the doctors couldn't give her any answer. They didn't know what caused what and if it was a delayed reaction from the vaccine because it was one week following the vaccine or if it was just coincidental. The patient due next week (scheduled for 23Mar2021) for her second dose and wanted to know if she should she take it. She ended up in the hospital for five days. Date of hospitalization was 11Mar2021. Reason for hospitalization was Anaphylactic reaction. Date of discharge from the hospital was 14Mar2021 (pending clarification). Event "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days" started from 11Mar2021 18:00. Seriousness Criteria: Hospitalization / Prolongation of hospital, hospitalized Duration of stay was 5d, event not recovered. The event required visit to Emergency Room. Treatment included steroids and fluids IV. "Tooth extraction" started from 08Mar2021 and treatment included Tylenol and Advil. Consumer stated she was still in a lot of pain after her tooth extraction (Mar2021). On 08Mar2021 she had a tooth extraction. After the procedure she had severe pain and she was taking Advil and by Thursday 11Mar2021 she had a lot of pain in abdomen and face. She went to ER 18:00 PM, she was going through a complete reaction. The patient required medical intervention: Corticosteroids, IV fluids. The patient was seen in the Emergency Department. The patient had hospitalized for 5 days. The patient was not admitted to an Intensive Care Unit. In Mar2021, the patient had Upper airway swelling, Respiratory distress, Cyanosis, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Generalized urticaria (hives), Generalized erythema, Angioedema (not hereditary), Generalized pruritus with skin rash, Localized injection site urticaria, Abdominal pain. No Bilateral wheeze/bronchospasm. No Stridor, No Increased use of accessory respiratory muscles, No Recession, no Grunting, no Dry cough, no Sneezing, No Rhinorrhea, No Shock, No Tachycardia, No Capillary refill time > 3 sec, No Decreased level of consciousness, No Loss of consciousness, No Generalized pruritus without skin rash, no Generalized prickle sensation, No Diarrhea, no Nausea, no Vomiting. Tachypnoea: Unknown. Measured hypotension: Unknown. Reduced central pulse volume: Unknown. The events did not require the initiation of new medication or other treatment or procedure. Lab work included Liver function over 10 000 in Mar2021. Patient's outcome following the potential anaphylactic reaction was Recovering. The outcome of the events "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days", "a lot of pain after her tooth extraction" was not recovered, of "pain in abdomen and face" was unknown, of the other events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events anaphylactic reaction, hepatitis acute, and respiratory distress with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
72 2021-04-01 heart attack Had I expected LAD heart attack on 15Feb after cardiologist said that heart is clear and risk is low... Read more
Had I expected LAD heart attack on 15Feb after cardiologist said that heart is clear and risk is low; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Right on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 72 years old. Medical history included diabetes mellitus, high blood pressure, hypothyroidism, and Known allergy: Sulfa from an unknown date and unknown if ongoing. Patient did not have COVID prior vaccination. Patient is not pregnant. Concomitant medication included metformin; metoprolol; amlodipine besilate (AMLOD); insulin degludec (TRESIBA); and clonidine hydrochloride (CLONIDIN) taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). The patient experienced "had i expected lad heart attack on 15feb after cardiologist said that heart is clear and risk is low" on 15Feb2021 05:00. The patient was hospitalized due to the event for 7 days on an unspecified date in 2021. The event required emergency room visit and physician office visit. Treatment was given for the event which includes Emergency Stent placement and update to medication. The patient underwent lab tests and procedures which included sars-cov-2 test (blood test): negative on 15Feb2021. Therapeutic measures were taken as a result of had i expected lad heart attack on 15feb after cardiologist said that heart is clear and risk is low (myocardial infarction). Outcome of the event was recovered with sequelae on 2021. Seriousness criteria was reported as hospitalization, medically significant, and life threatening. Information on lot number/batch number has been requested.
72 2021-04-01 atrial fibrillation Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hos... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hospital for her first covid vaccine. After approximately 10 minutes vaccination, she started feeling dizzy, light headed, slightly nauseated. Reports sweating and cold hand. Patient was taken to the emergency department and later admitted to the hospital with new onset afib/aflut with RVR following first dose of Pifzer Covid-19 vaccination. Further workup revealed reduced EF on ECHO and elevated LFTs. Patient was treated and discharged home.
72 2021-04-05 cerebrovascular accident Severe pain started in my back and knee on 3/11/21 and I was unable to walk properly. On 3/30/21, I... Read more
Severe pain started in my back and knee on 3/11/21 and I was unable to walk properly. On 3/30/21, I had a stroke. Treatment is ongoing. Outcome is TBD.
72 2021-04-06 cerebrovascular accident, blood clot 1st symptom 3/19/21 at 5:30 am - Weakness in fingers on right hand. Called nurse line, they recommen... Read more
1st symptom 3/19/21 at 5:30 am - Weakness in fingers on right hand. Called nurse line, they recommended calling EMT. EMT said no stroke but could go to urgent care for further evaluation. Urgent care recomended ER. ER recommended appointment with Neurology 2nd symptom 3/21/21 slight droop on right side of mouth. Went to ER in Hospital. MRI revealed clot. Additional ultra sound of heart and carotid arteries clear. Final diagnosis: Subacute CVA-Lt Centrum Semiovale w/ right facial droop and right hand deficits. Recomendations: Nuerology evaluation, Outpatient PT/OT for right hamd deficits. Hospitilization: 1 day Hospital Name: Unnamed City: Unnamed State: Unnamed
72 2021-04-06 pulmonary embolism Pulmonary Embolism resulted in emergency care and 4 days in hospital with blood thinners and eventua... Read more
Pulmonary Embolism resulted in emergency care and 4 days in hospital with blood thinners and eventually sent home with having to give self infections and oral blood thinners. All blood tests do not show that it came from a DVT or or that it was inherited therefore, can not show where the clot came from. It is unknown or considered "Unprovoked" due to unknown cause. This causes a concern for an adverse reaction from the vaccine
72 2021-04-07 troponin increased woke up with body aches, fatigue, muscles just hurt, 2nd COVID vaccine on Tuesday. Had COVID back in... Read more
woke up with body aches, fatigue, muscles just hurt, 2nd COVID vaccine on Tuesday. Had COVID back in October 2020, Took 400 mg ibuprofen PTA.
72 2021-04-08 platelet count decreased Low platelets, body rash, flat red splotches, unexplained bruises and black scabs/ blister on lips
72 2021-04-08 blood clot, heart rate irregular, fast heart rate, pulmonary embolism Two days after vaccine experienced shortness of breath and tachycardia. Went to ER. After testing, d... Read more
Two days after vaccine experienced shortness of breath and tachycardia. Went to ER. After testing, diagnosed with pulmonary emboli in each lung (one each). 1 blood clot also found in ankle.
72 2021-04-09 blood clot the problem was a bloodclot; slight swelling of right foot; This is a spontaneous report from a cont... Read more
the problem was a bloodclot; slight swelling of right foot; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 09Mar2021 13:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure and allergy to tape. Concomitant medications included levothyroxine; olmesartan; metformin; all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 15:00, the patient noticed slight swelling of right foot and on 14Mar2021, the swelling increased so the patient texted the nurse who arranged appointment. The nurse said to contact the doctor and the patient spoke with registered nurse (RN) on duty who told the patient to go to the emergency room (ER) because the symptoms indicated the problem was a blood clot. The ER doctor examined and ordered an ultrasound and the results confirmed blood clot. The patient was given a prescription for blood thinner to take for 21 days (times/day, 15mg) and was told to make an appointment with the primary doctor. The patient's doctor was on spring break and she was walked in to see another doctor who said swelling looked improved and showed her where the clots were located. The patient saw her primary doctor today and she ordered a visit with a hematologist as soon as possible (ASAP) because of concerns about possible underlying issues. The outcome of events, slight swelling of right foot and the problem was a blood clot was recovering. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
72 2021-04-13 chest pain Pt was admitted with chest pain and thoracic arotic dissection 6 days after her second covid 19 vacc... Read more
Pt was admitted with chest pain and thoracic arotic dissection 6 days after her second covid 19 vaccination. CT imaging showing a dissecting mid descending upper abdominal aneurysm. She was transferred to the ICU on an esmolol drip and ultimately transferred to hospital MICU where she remains hospitalized
72 2021-04-13 heart attack er visit turned into a hospital stay in ICU....due to blood clots that were in the lungs that were ... Read more
er visit turned into a hospital stay in ICU....due to blood clots that were in the lungs that were so pervasive a heart attack ensued due to the pressure from the lungs
72 2021-04-14 blood clot Clots Ongoing
72 2021-04-14 pulmonary embolism bilateral multiple pulmonary emboli (left and right main pulmonary arteries)
72 2021-04-15 deep vein blood clot, pulmonary embolism 2 days after the second Pfizer Covid vaccine patient was admitted to hospital with diagnosis of bila... Read more
2 days after the second Pfizer Covid vaccine patient was admitted to hospital with diagnosis of bilateral pulmonary emboli, right peroneal vein DVT. Showed right ventricular strain. Anticoagulated and discharged home after 2 days. On anticoagulation. Follow-up 12 days later me back to baseline.
72 2021-04-15 blood clot, pulmonary embolism I started being really short of breath and felt pain/inflammation in lower body. I remember telling ... Read more
I started being really short of breath and felt pain/inflammation in lower body. I remember telling my brother I hurt everywhere below my waist; was just home from work where on my feet unless I sit down to rest. It all culminated with increased breathlessness and went to emergency at hospital at 8:30 pm on April 22, 2021. Diagnosis was MANY pulmonary embolisms, some large. I have taken week long road trips for the past several years with hours and hours at the wheel with no problems. It just seems like a real strange coincidence of the vaccine and subsequent symptoms.
72 2021-04-15 low platelet count, cerebral haemorrhage, deep vein blood clot, haemoglobin decreased, platelet count decreased Patient with Hx of AML received 1st dose COVID vaccine 2/10/2021, 2nd dose 3/4/2021. She developed ... Read more
Patient with Hx of AML received 1st dose COVID vaccine 2/10/2021, 2nd dose 3/4/2021. She developed DVT of the right leg, AML relapse. The patient has been diagnosed with AML back in 2016 and underwent several lines of therapy including chemotherapy with 7 and 3 and the last treatment was decitabine with maintenance treatment with ivosidenib. Having severe leukocytosis and right-sided leg edema with DVT raised concern about blast crisis and leukostasis. Patient was admitted to hospital and received. ceftriaxone and azithromycin for possible pneumonia. She underwent leukophoresis on the 4/6/2021, 4/7/2021. Patient received IV heparin gtt for DVT but later on was on hold given worsening thrombocytopenia. She was transferred from one hospital to another hospital. I do not think the development of DVT was due to COVID vaccine. But prior to COVID vaccine, patient was in AML remission.
72 2021-04-17 chest discomfort congestion in her chest; The congestion in her chest is, she knows it's there, it's tight,; cough; a... Read more
congestion in her chest; The congestion in her chest is, she knows it's there, it's tight,; cough; arm was sore; This is a spontaneous report from a contactable consumer (patient) reporting for herself. This is report 1 of 2. A 72-year-old consumer (female) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266, Expiry date: May2021) via an unspecified route of administration on 25-FEB-2021 at left arm around 11:30 -12:30 and patient received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8730/GR8730) via an unspecified route of administration on 25Mar2021 both as a single dose for COVID-19 immunization. Medical history and concomitant medication reported as diabetes and blood pressure medicine (From: Unspecified To: Ongoing), has since about 2015 or 2013 or something like that. She declines to provide her medication. She is not a serious diabetic. Sometimes she does not have to even take the diabetes medication because she keeps her A1C is so low she doesn't have to take the diabetes shots. She did not receive any other vaccines within four weeks prior to the vaccination. She didn't have any other real problems with the first dose of Pfizer COVID-19 Vaccine other than her arm getting sore. For her second Pfizer COVID-19 Vaccine she don't have to bother her arm. She had a little cough started sometime last week before she took the second Pfizer COVID-19 Vaccine. The cough doesn't happen all the time. She was coughing quite regular every 2-3 minutes before. She got the Diabetic Tussin cough syrup which has no sugar or alcohol. After taking that cough started quieting down. She was asking is it a regular cough or did the Pfizer COVID-19 Vaccine cause the cough. She's taking it once a day sometimes twice a day. It is nasty cause it's got nothing in it. Maybe she is not taking it enough, it says to take it every 4 hours, maybe she is not taking it enough, she does not know. She is taking it maybe once or twice daily, maybe she takes it more. She reports it's not a constant cough. She also has some congestion in her chest. The congestion in her chest it's tight, she just knows it's there. Her chest congestion is staying about the same. If she gets rid of the cough, she'll get rid of the chest congestion she guesses. Caller reported that people are not educating themselves on these shots, referring to the Pfizer COVID-19 Vaccine shots. They'll tell you it's gone kill you; that she does not believe because some people have died, they took the shot and they didn't get a chance to take the second shot and they passed away. And they are telling her not to get the vaccine because it's going to hurt her. She's going to put it in God's hands and take that Pfizer COVID-19 Vaccine to help prevent or at least have it in her system. She's 72 years old and concerned about herself. The outcome of the event arm sore is unknown, little cough with outcome recovering, congestion in her chest outcome not recovered. Follow up (29Mar2021): This is a Follow-up spontaneous report received from a contactable consumer reporting patient information, event information, concomitant medication. Follow-up attempts are needed. Information on lot/batch number was obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021347466 Pfizer
72 2021-04-17 fainting faint; tired; chills; mild diarrhea; This is a spontaneous report from a contactable consumer (patie... Read more
faint; tired; chills; mild diarrhea; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received bnt162b2 dose 1 intramuscular in right arm on 13Feb2021 16:00 PM (Lot number unknown) at single dose for COVID-19 immunization. The patient had known allergies to penicillin and shellfish. Other medical history was not provided. The patient's concomitant medications included atorvastatin, vitamin, fish oil, probiotic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient became faint, tired and had chills which caused mild diarrhea from 13Feb2021 05:00 PM. The patient did not receive treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient received the bnt162b2 dose 2 intramuscular in Right arm on 06Mar2021 01:15 AM (Lot number unknown) at single dose for COVID-19 immunization. The outcome of the event events was recovered. Information on the lot/batch number has been requested.
72 2021-04-17 chest discomfort, body temperature decreased, heart attack, heart rate increased, blood clot hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/cli... Read more
hoped she wasn't having a heart attack; Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195; Drenched in sweat/sweating/sweating like a dog in the middle of the night; Wasn't feeling well; Tightness in chest; Cough; Sinuses congested; Sore; Puffy, bubbled up arms, inflamed; Puffy, bubbled up arms, inflamed; Feverish/felt hotter than usual; Really, really tired/wiped out tired; so sleepy; Sore Arm/her arm started to hurt; Nauseous; Sore Throat/throat hurts; eyes half closed/eyes closing; Puffy Face; blood clot; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733, expiry date: unknown), via an unspecified route of administration, on 29Mar2021 11:45, as single dose, for COVID-19 immunisation. Medical history included ongoing latex allergy (developed welts where the straps met the skin) diagnosed 20-30 years ago; ongoing dye allergy (developed warm soreness to leg, tightness in the chest, could not breathe) diagnosed many years ago; sulphite allergy (diagnosed about 1975-1980; cannot eat processed foods, bleached foods, frozen pre-made foods; tries to eat only single item foods; last anaphylactic reaction after eating olive oil at a restaurant because it had sulphites in it; Mother was possibly allergic to sulphites; Son also allergic to sulphites); and blood pressure that runs low. The patient previously took epinephrine and experienced epinephrine allergy; ciprofloxacin (CIPRO) and experienced Cipro Allergy (eyes closed, got puffy, couldn't breathe); amoxicillin for abscessed tooth and had a reaction because of the sulphites in it; epinephrine (EPIPEN) and experienced epinephrine allergy (does not use it anymore); plantago ovata (METAMUCIL) which she then found out the orange one had sulphites. Historical vaccine included flu shot for immunization and she experienced 104-degree temperature and was sick as a dog and she went to the emergency room (she had flu shot maybe 3 times). Ongoing concomitant medication included multivitamins. The patient got her first dose of BNT162B2 on 29Mar2021 at 11:45. On the same day, once she got home, she became really, really tired/wiped out tired; was so sleepy; experienced sore arm/her arm started to hurt; was nauseous; had sore throat/throat hurt; eyes half closed/eyes closing and puffy face. On 30Mar2021, the patient experienced elevated pulse/her pulse got too high/pulse was 165 beats per minute/climbed up to 195. Her heart rate was 194 at some point for a couple of minutes then stayed at 165 for a long time. She hoped she wasn't having a heart attack. She had tightness in her chest, wasn't feeling good and was coughing. She stayed in her bed to wait out her symptoms. These lasted for 10 minutes (as reported). She started meditating hoping her heart rate would decrease and it did after about 15-20 minutes. The patient also felt feverish/felt hotter than usual. Before she took the vaccine on 29Mar2021, her temperature was at 96. She stated that her temperature usually runs low as 95-06 degrees. She also felt like her sinuses were congested; was sore; had puffy, bubbled up arms, inflamed. The patient hoped it was not a blood clot she developed. At the time of the report, the patient stated that her heart rate was 61 beats per minute, earlier it was in the 70s; and her temperature was at 96.3. Her second dose is scheduled on 19Apr2021 and mentioned that if these were her reactions with the first dose, she is questioning getting the second dose. The outcome of "blood clot", "hoped she wasn't having a heart attack", "Wasn't feeling well", "Tightness in chest", cough, and sinuses congested was unknown. The patient recovered from "Drenched in sweat/sweating/sweating like a dog in the middle of the night", and "Elevated Pulse/high pulse/pulse was 165 beats per minute/climbed up to 195" on 30Mar2021; and was recovering from "Sore Arm/her arm started to hurt", and "eyes half closed/eyes closing". The outcome of the remaining events was not recovered. Information on the lot/batch number has been obtained. Additional information is expected.
72 2021-04-18 pulmonary embolism Moderate bilateral pulmonary embolus - stable clinical status Patient was seen in outpatient clinic ... Read more
Moderate bilateral pulmonary embolus - stable clinical status Patient was seen in outpatient clinic with back pain and mild shortness of breath. She had normal vital signs. Due to history of DVT, stat CT chest was ordered. Patient was notify of result and Xarelto was started. She met criteria for outpatient treatment and will follow up in our clinic.
72 2021-04-18 cerebrovascular accident Suffered a stroke; blood clots in the brain; This is a spontaneous report from a contactable consume... Read more
Suffered a stroke; blood clots in the brain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 04Jan2021 14:00 at a single dose for COVID-19 immunisation. Medical history included heart valve replacement, thyroid issues and headache. Concomitant medications included medications in the last two weeks (unspecified). The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization. On 24Feb2021 12:00 PM, the patient suffered a stroke - blood clots in the brain. Had brain scans earlier in the year for headaches but nothing found. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient was hospitalized for the events for 7 days. Therapeutic measures were taken as a result of the events which included surgery to break and remove the clot. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. The facility where the vaccine was administered was in a Public Health Clinic facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovered on an unspecified date. Information about lot/batch number has been requested.
72 2021-04-20 loss of consciousness loses her voice; she just sat down in a chair, and everything went black for a second; second COVID-... Read more
loses her voice; she just sat down in a chair, and everything went black for a second; second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021; second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021; She hurt more, too, in her L4 & L5 vertebrae; not feeling well; body was aching/She hurt more, too, in her L4 & L5 vertebrae, and had pain throughout her whole body.; Headache; Chills; Her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose; Her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 24Mar2021 13:53 (at 72-years-old) as single dose for COVID-19 immunization. Medical history included ongoing Spinal leak (Diagnosed with a spinal leak about 1-1/2 years ago. She said she has had spinal leaks, on and off, since that time.), ongoing Oral lichen planus (Stated she was diagnosed with Oral Lichen Planus between 10-15 years ago), ongoing Rheumatoid arthritis (Stated she was diagnosed with Rheumatoid Arthritis at least 3 years before she was diagnosed with Oral Lichen Planus. She said she had been tested for food allergies & as long as she stayed away from gluten, chicken, tomatoes & some other things, she did not have a problem with her rheumatoid arthritis. She said gluten, in particular, triggered her rheumatoid arthritis.), Gluten (triggered her rheumatoid arthritis), fractured her L4 vertebrae in last summer 2020, sciatica from Feb2020 (pinched sciatic nerve since Feb2020), Bone density issue. Stated her family has a history of autoimmune diseases, like Lupus. Concomitant medications included diphenhydramine, paracetamol (EXTRA STRENGTH TYLENOL PM, NDC Number: 50580-937-19, Lot Number: SLA006, Expiration Date: Aug2024); ibuprofen (ADVIL, UPC Number: 305730154604, Lot Number: EG1007, Expiration Date: Jul2023); gabapentin ("ACI Health", Expiration Date of 05Mar2022). The patient previously took first dose of bnt162b2 (Lot number: EN6198) on 02Mar2021 (at 72-years-old) Intramuscular on left arm for covid-19 immunization but experience Left arm was sore, left arm soreness went away after 2-3 days. The patient previously took Flu vaccine but experienced Mouth sores. Reported she had both COVID-19 Vaccine doses. She said she got the typical side effects of a headache, chills, not feeling well, and her body was aching. She clarified those side effects started late the night of her second COVID-19 Vaccine shot (24Mar2021). She said those side effects were mild, and resolved in about 2 days. She said she didn't think much of those side effects, until the next day (25Mar2021), when the other side effects started (blacked out, lightheaded, equilibrium was off). She said her left arm was sore after her first COVID-19 Vaccine dose. She said she didn't treat her left arm soreness, and the left arm soreness went away after 2-3 days. Reported on 25Mar2021 at about 11:30AM, she blacked out. She said she just sat down in a chair, and everything went black for a second. She said she then got really lightheaded, and her equilibrium was off. Reported she had spinal leaks, on and off, for the past 1-1/2 years. She clarified that her doctors didn't think the spinal cord leaks would be contraindicated with the COVID-19 Vaccine. She said all her doctors said it was up to her if she wanted to get the COVID-19 Vaccine because she previously had problems with the flu vaccine. She clarified she had a flu vaccine about 15 years ago, and the day after the flu vaccine, she got mouth sores, and the mouth sores got worse. She said her local doctors didn't know how to treat her mouth sores, so she went to the clinic. She said the clinic doctors told her she had Oral Lichen Planus, and the Oral Lichen Planus was caused by the flu vaccine she had received. She stated she did not have any information (NDC, Lot, & Expiration Date) for the flu vaccine she received back then. She stated she has not had a flu vaccine since that time. Reported her spinal cord leaks caused equilibrium, and lightheadedness. She said she thought her second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021 11:30. She said her lightheadedness, and equilibrium being off was still going on. Reported she hurt more, too, in her L4 & L5 vertebrae, and had pain throughout her whole body. She clarified she fractured her back (specifically her L4 vertebrae) last summer (2020), and her L4 vertebrae had since healed. She said she had a pinched sciatic nerve since Feb2020. She clarified her L4 and L5 vertebrae move because she had 3 blood patches to treat her spinal cord leaks. She said when the blood patches were done a lot of force was used to stop the spinal leaks. She said the first blood patch caused her buttocks to really hurt. She said she had 2 more blood patches. She said she was not too sure about second blood patch, but with the 3rd blood patch, she was miserable. She said she had physical therapy weekly, and she may have to have her back fused. She said she had a bone density issue that apparently was mentioned in her medical records when she was in her 50s. She said she was never treated for her bone density issue until after she fractured her L4 vertebrae in 2020. No further details provided. Reported her last blood work was 3-4 months ago. No further details provided. Reported her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose (Mar2021). She clarified she started to get Oral Lichen Planus mouth sores a couple days after she received her second COVID-19 Vaccine. She said she can go months without having any issues, and then get the Oral Lichen Planus mouth sores. She said she took medication to manage her Oral Lichen Planus. She said with the medication, the Oral Lichen Planus mouth sores are gone within 24-48 hours. She said with her latest Oral Lichen Planus mouth sores, she put her medication on the mouth sores, and the mouth sores seemed to settle down, but the mouth sores didn't go away completely. She said the day before yesterday (03Apr2021), her Oral Lichen Planus mouth sores got worse again, and are staying that way, even with using the medication. Oral Lichen Planus Treatment: Stated she was applying Clobetasol Propionate Ointment UPS 0.05% to her mouth sores after she eats, or about 3-4 times a day. NDC Number: 51672-1259-6, Lot Number: 332450, Expiration Date: Aug2021. For other treatment she had medication she takes every day, and she continued to take the medication to help her symptoms. She said she had physical therapy twice a week for about 1-1/2 hours, as well as, doing physical therapy on her own. She clarified she does the physical therapy for her sciatica and vestibular issues, saying she was not steady on your feet. She said she does physical therapy about 4 hours a week. Reported her doctors told her she would not survive the Corona Virus if she were to get it because of her underlying health issues. No further details provided. Reported her doctors said there was no information reporting that the COVID-19 Vaccine was contraindicated in people with spinal cord leaks, and how the COVID-19 Vaccine would affect people with spinal cord leaks. She said she thought she may have been fighting things because the COVID-19 Vaccine was acting like the flu vaccine (when she first developed Oral Lichen Planus). She said she thought her symptoms after her second COVID-19 Vaccine dose may have had something to do with her spinal cord leak because she had similar symptoms (lightheadedness & equilibrium issues) with her spinal cord leak. She said with her spinal cord leak, she also had pain and loses her voice. No further details provided. The outcome of the events she just sat down in a chair, and everything went black for a second was recovered on 25Mar2021; headache was recovered in Mar2021; chills was recovered in Mar2021; not feeling well was recovered in Mar2021; body was aching/she hurt more, too, in her l4 & l5 vertebrae, and had pain throughout her whole body was recovered in Mar2021; loses her voice was unknown; while for other events was not recovered.
72 2021-04-24 arrhythmia, palpitations Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racin... Read more
Tired, can't sleep; Tired, can't sleep; Heart racing, described as irregular arrhythmia; Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding; Arm barely sore; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 72-years-old , via an unspecified route of administration, administered in Arm Left on 31Mar2021 11:40 am as single dose for covid-19 immunisation. Medical history included ongoing food allergy, she had anaphylactic shock from a food allergy (she was 40 at the time and she doesn't eat anything she is allergic to), sinus infection and then got horrible hives under her eyes. No Prior Vaccinations (within 4 weeks). Concomitant medication was eye drops every night. No additional vaccines administered on same date of the Pfizer Suspect. The patient previously took epipen had two episodes when she was 40. She is bad about carrying her EpiPen, she forgets it. She was allergic to Amoxicillin. At 11:40 am last Wednesday patient had the vaccine, and around 4 or 5 pm, her heart started pounding for 10 seconds, and it felt like forever. An hour later, her heart started pounding again. It happened twice an hour apart and the second time lasted longer. It described as hard pounding. It started at 4 or 5 pm and then for 4.5 hours there was nothing, but then her heart started racing. At around 4 or 5 pm her heart was pounding, than around 9:30 pm her heart started racing and beating fast, she could feel it. She lives in a rural community and her husband called the local fire station and asked if he could take her there, to the station, so that she could have her heart checked. She was hooked up to a monitor and the paramedics said that she had an irregular arrhythmia and needed to go to the hospital by ambulance. Her heart rate was 115 to 130 beats, then 140 beats, at the hospital. It was about 11pm when she was evaluated and then left in the ambulance, as she was 45 minutes from the hospital. The paramedics would have, the arrhythmia, on record and that 5 minutes before she got to the hospital, the paramedic said her heart rhythm was normal. She was not admitted to the hospital, but held in observation and left the hospital at 4:30 in the morning. She hasn't felt anything after that. it was only one time she thought her heart was going faster, after that, but it didn't happen again. It is currently no problem and even at the hospital, the heart racing stopped and it was normal. The doctor in the emergency room said she was totally normal. Her arm was barely sore, when touched, and noticed this when she was being helped to the bathroom in the emergency room, maybe later in the afternoon, it was not hurting. But she didn't have any other events. She was tired the next day on 01Apr2021. She was up all night in the emergency room. people say that one will be tired, as an effect, but she can't say that it is because of the vaccine, or if she only had 3 hours of sleep. She hasn't been sleeping but she can't attribute it to the vaccine. She can't attribute this to the vaccine, that she has been tired lately and not sleeping. Event outcome of irregular arrhythmia and Heart racing, described as irregular arrhythmia/Heart pounding, hard pounding was recovered on 31Mar2021, of Arm barely sore was recovered on 02Apr2021, of the remaining was unknown. Information about Batch/Lot number has been requested.
72 2021-04-25 chest pain, heart attack This 72 year old female received the Covid shot on 03/15/2021 and went to the ED on 4/3/2021 and... Read more
This 72 year old female received the Covid shot on 03/15/2021 and went to the ED on 4/3/2021 and was admitted on 4/3/2021 with abdominal pain, nausea, chest pain, NSTEMI and died on 04/24/2021 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
72 2021-04-26 blood pressure increased, heart rate increased, palpitations 107 °F fever; a bit of a cold the same night she got vaccinated; Blood Pressure Elevated; Cough; He... Read more
107 °F fever; a bit of a cold the same night she got vaccinated; Blood Pressure Elevated; Cough; Heart Rate Elevated; Felt palpitations; This is a spontaneous report from a contactable other health care professional. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 09Apr2021 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Thyroid Condition States was diagnosed about 23 years ago, ongoing High Blood Pressure Diagnosed 3-4 years ago. Concomitant medications included ongoing levothyroxine taken for thyroid condition; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) taken for hypertension. On an unspecified date, the stated she had a 107 °F fever, "a bit of a cold the same night she got vaccinated, took amoxicillin and is responding good." On 09Apr2021, the blood pressure elevated, cough, Heart Rate Elevated, Felt palpitations. The patient underwent lab tests and procedures which included blood pressure measurement: 140 some high blood pressure problems, sometimes it goes to 140, blood pressure measurement: 170 on an unspecified date blood pressure went up as high as 170, blood pressure measurement: 157/68 on an unspecified date her blood pressure is still going up at times 157/68, body temperature: 107 fahrenheit on an unspecified date 107 °F fever, heart rate: 102 on unspecified date Her heart rate was also 102 , heart rate: 82 on unspecified date Her heart rate is 82. The outcome was recovering. Relatedness of drug to reaction(s)/event(s): Reaction assessed : Blood Pressure Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result : Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Cough. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s). Reaction assessed : Heart Rate Elevated. Source of assessment : Primary Source Reporter. Method of assessment : Global Introspection; Sender's Comments: Based on the current available information after FU and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hyperpyrexia cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
72 2021-04-26 blood pressure decreased, heart attack, cardiac arrest With in one hour patient experienced severe Vomiting and Diarrhea. She had called her Doctors offic... Read more
With in one hour patient experienced severe Vomiting and Diarrhea. She had called her Doctors office. She saw a PA which told her to drink more water. She experienced Uncontrollable Diarrhea For 18 days. She was sent to Hospital by ambulance on Monday March 15, 2021. She was was treated with an IV and sent home discharged with Weakness. She continued to have Uncontrollable Diarrhea to were she was wearing Diapers. She fell from Weakness on March 16, 2021 to the point where she laid on the floor for an hour and half before she could drag herself up. She went to Hospital on March 18, 2021. Her blood pressure dropped and was admitted to ICU on the March 18th. She started suffering from a Heart attack and was taken back to have a stent put in her wrist to help with possible heart blockage. She went into cardiac arrest and passed away.
72 2021-04-26 pulmonary embolism had large bilateral PE; This is a spontaneous report from a contactable nurse. A 72-year-old female ... Read more
had large bilateral PE; This is a spontaneous report from a contactable nurse. A 72-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Jan2021 (lot number EL1283) on Left arm at single dose for COVID-19 immunization. Facility type vaccine was at urgent care center. Medical history included hypertension. Concomitant medications were not reported. The patient had large bilateral PE (pulmonary embolism) several weeks after vaccine on 18Feb2021. The event resulted in emergency room visit, physician office visit and Hospitalization for 2 days. Serious criteria Life-threatening also reported for the event. The event was treatment with anticoagulation. The outcome of the event was resolved in 2021.; Sender's Comments: A causal relationship between the event "had large bilateral PE" and suspect product BNT162B2 is possible based on the information provided and a temporal association in this 72-year-old female patient with hypertension. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
72 2021-04-28 cerebrovascular accident mild stroke; loss of taste and smell; loss of taste and smell; fatigue; headache; This is a spontane... Read more
mild stroke; loss of taste and smell; loss of taste and smell; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN8732) via an unspecified route of administration on 23Mar2021 at 08:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, and a-fib (atrial fibrillation), all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications ("other medications in two weeks") included carvedilol, hydrochlorothiazide and losartan, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 24Mar2021 the patient experienced loss of taste and smell, fatigue and headache and on 26Mar2021 the patient experienced mild stroke. All events resulted in an emergency room visit and resulted in hospitalization from 26Mar2021 to 29Mar2021. The clinical course was reported as follows: "Second dose on 23Mar2021, loss of taste and smell, fatigue, headache on 24Mar2021 and 25Mar2021. Went to (Hospital name) on Friday 26Mar2021 and diagnosed with a mild stroke. Stayed in hospital until Monday 29Mar2021. Prescribed a blood thinner (Eliqus) per already engaged cardiologist. As of 13Apr2021 still no taste or smell; gaining energy." Therapeutic measures were taken in response to the adverse events and included treatment with "medications to lower blood pressure and a blood thinner". The patient underwent a nasal swab COVID-19 test post vaccination on 26Mar2021 which was negative. The clinical outcomes of the events loss of taste and smell were not recovered; mild stroke, fatigue and headache were recovered/resolved on unspecified dates.
72 2021-04-30 loss of consciousness like I was going to pass out.; felt nauseous; This is a spontaneous report from a contactable consum... Read more
like I was going to pass out.; felt nauseous; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 05Mar2021 at 15:30 (Batch/Lot Number: EN6203), at the age of 72 years old, as single dose for Covid-19 immunisation. Medical history included suspected covid-19 from Mar2020 to an unknown date (I believe I had Covid. Had all kinds of symptoms for many months after). The patient has no allergies to medications, food, or other products. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. On 24Mar2021, 19 days after, the patient felt nauseous and like she was going to pass out. The patient underwent lab test which included Covid-19 test: unknown, in 2021. The patient did not receive any treatment for the events. Outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
72 2021-05-06 chest pain the day after the vaccine I had chest pains......never had them before......hope not to have them ag... Read more
the day after the vaccine I had chest pains......never had them before......hope not to have them again.....very scarey
72 2021-05-10 fast heart rate, atrial fibrillation Covid 19 vaccine exacerbated her chronic fatigue syndrome; Covid 19 vaccine exacerbated her chronic ... Read more
Covid 19 vaccine exacerbated her chronic fatigue syndrome; Covid 19 vaccine exacerbated her chronic fatigue syndrome; atrial fibrillation; tachycardia/ heartrate got was 222 beats per minute; missing heartbeats; chills; fever; fatigue; lethargic; felt crummy; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13Apr2021 15:00 (Batch/Lot number was not reported) at age of 72 years as single dose for covid-19 immunisation. Medical history included ongoing chronic fatigue syndrome at age 32 (she had been doing natural therapy and had gotten herself to a stable period but her chronic fatigue syndrome was still an issue sometimes), atrial fibrillation (had been admitted to the hospital because of it, she was not admitted to the hospital when she had atrial fibrillation after receiving her Covid 19 vaccine). The patient's concomitant medications were not reported. Historical vaccine included the first flu vaccine she every received sent her over the moon. Clarified she was in bed sick after receiving the flu vaccine. Patient was calling because she didn't do well with her first Pfizer Covid 19 vaccine. After the Covid 19 vaccine she experienced chills and fever on 13Apr2021 for a couple days. Then she had fatigue on 13Apr2021and that was a few days of her own chronic fatigue syndrome flaring up. She also had some problems with her heart like atrial fibrillation and tachycardia on 18Apr2021. She saw her cardiologist and he wanted her to do the dye stress test where she ran on the treadmill. The day her stress test was scheduled was the same day as her second Covid 19 vaccine. She was calling to find out if she can get the dye at her stress test and run on the treadmill and get the Covid 19 vaccine on the same day. Or does she need to put the stress test off for a couple weeks. She felt like the dye from the stress test and the Covid 19 vaccine might be too many chemicals in her body for one day. She felt like the Covid 19 vaccine exacerbated her chronic fatigue syndrome. She reported that something as simple as to much sugar or to much sun or exertion can also exacerbate her chronic fatigue syndrome. She was prepared in her thinking that the Covid 19 vaccine would be difficult for her because of her history with chronic fatigue syndrome. She had chills and a fever for a few days after the Covid 19 vaccine. She did not take her temperature to get a recorded number. She was lethargic and really felt crummy on 13Apr2021 for about the first 3 days. On day 4 she was better. Then the heart stuff started. Clarified, the atrial fibrillation and tachycardia started. She took medicine as needed for her atrial fibrillation and tachycardia. She had the atrial fibrillation and the tachycardia for about 3 days in a row. She reported she was stable now. She was able to monitor her heartrate on her watch. She then printed out her heart rate readings from her watch to take to her doctor. The highest her heartrate got was 222 beats per minute and that happened a couple times. Her watch only showed her heart rate as 150 beats per minute but when she printed the information it showed her true heart rate. She did see an electrophysiologist before she received her first dose of the Covid 19 vaccine. She was preparing herself for if anything was going to go wrong when she received the vaccine, she wanted to know what to do. She wanted to prepared in case the Covid 19 vaccine caused her any trouble. She was prescribed Diltiazem by her cardiologist to take as needed when she was having the tachycardia and atrial fibrillation. She was taking 15mg three times a day on the three days that she had the atrial fibrillation and tachycardia and it helped. She received her first dose of the Covid 19 vaccine on 13Apr2021 and according to her watch she started missing heartbeats on 14Apr2021. The atrial fibrillation and the really bad heart stuff started on 18Apr2021 and went on until 22Apr2021. She would say her heart issues started to resolve on the afternoon of the 22Apr2021. She was still missing heart beats according to her watch but nothing bad. She saw her cardiologist on Friday, 23Apr2021 and at that appointment she was in normal sinus rhythm. She has had some ups and downs since the 23Apr2021. Her second Covid 19 vaccine was scheduled for 04May2021 at 11:00AM. She did have a 3D echocardiogram and based on that, the doctor wanted to rule out any blocked arteries and that's why she's doing the stress test. AEs (atrial fibrillation and tachycardia) require a visit to Physician Office. Outcome of events chills, fever, lethargic, felt crummy was recovered on 17Apr2021, and the other events was unknown.
72 2021-05-11 low blood oxigenation Pneumonia due to COVID-19 virus ED to Hosp-Admission Discharged 4/14/2021 - 4/22/2021 (8 days) ... Read more
Pneumonia due to COVID-19 virus ED to Hosp-Admission Discharged 4/14/2021 - 4/22/2021 (8 days) Last attending ? Treatment team Maxillary fracture Principal problem Final Summary for Deceased Patient Admission Date: 4/14/2021 Discharge Date: 4/22/2021 Final Diagnosis Principal Problem: Maxillary fracture (CMS/HCC) Active Problems: Pneumonia due to COVID-19 virus Demand ischemia (CMS/HCC) Dyslipidemia Essential hypertension Acute kidney injury (CMS/HCC) Glomerulonephritis, IgA Lactic acidosis Septic shock (CMS/HCC) Cytomegalovirus (CMV) viremia (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Left femoral vein DVT (CMS/HCC) Malnutrition (CMS/HCC) Hypothermia DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Hypoxia [R09.02] Acute respiratory failure with hypoxia (CMS/HCC) [J96.01] Fall, initial encounter [W19.XXXA] COVID-19 [U07.1] COVID-19 virus infection [U07.1] Hospital Course Patient is a 72-year-old female with past medical history of hypertension, hyperlipidemia, recent hospitalization due to CMV viremia and an AKI and myelosuppression. Who presented to the emergency room after a fall in her house on 4/14. She had significant face pain and was hypoxic with an O2 saturation of 68% on room air on presentation. She was then found to be Covid positive. Initially admitted to the medical floor however required increasing amounts of oxygen and was ultimately transferred to the ICU on 4/16. She was maintained on nonrebreather oxygen until the evening of 4/21 when she was intubated and increasing vasopressor requirements. Given her worsening condition, her husband elected to palliatively extubate and pursue comfort care. Time of death was 10:02 AM on 4/22/2021. Disposition of the body: morgue
72 2021-05-13 chest pain, heart rate increased, inflammation of the pericardium, fast heart rate Pericarditis; Pneumonia; Tachycardia; Headache; Achy; Fatigue; Heart rate was higher; Pain in my bac... Read more
Pericarditis; Pneumonia; Tachycardia; Headache; Achy; Fatigue; Heart rate was higher; Pain in my back, in my shoulder; I was very ill, I was unable to do anything; Pain in my back, in my shoulder; pain in my chest; Sed Rate was 48; by 04Feb2021 and 10Mar2021 my White blood count went down from 16,600 to 11,400; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 72-years-old via an unspecified route of administration administered in arm left on 27Jan2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. Medical history included hypertension (blood pressure high) from an unknown date and unknown if ongoing, pacemaker from an unknown date. Concomitant medication included a 10 mg high blood pressure pill (unspecified). The patient reported that after her COVID shot on 27Jan2021, she had the headache, achy, fatigue on unspecified dates; but she know that her heart rate was higher, she was exercising. It was higher than it normally was and her pacemaker, she have a pacemaker and she happen to have a pacemaker check 4 days after her COVID shot which they monitor every 7 months and it was working and it was pacing 100 percent of the time which was much higher than it had been before and the week after the shot she started having pain in her back, in her shoulder and it was hard to breathe, it's hard when she breathe and by the next day she ended up in the emergency room where she was diagnosed with pneumonia, tachycardia and pericarditis all on unspecified dates. She further reported that she was still suffering from them. She have some other tests on the 04Feb2021in the ER, her hemoglobin was 14.6 and on 10Mar2021 it was 11.6 so, it gone down 3 points, by 04Feb2021 and 10Mar2021, her White blood count went down from 16,600 to 11,400 and her Sed rate count (ESR or sed rate) was 48 (clarification unknown). She was very glad that she had the vaccination and was not sad that she had it but she was very ill, she was unable to do anything but lie around for about 25 days from 27Jan2021 to 25Mar2021 so for 2 months, and she still have pain in her chest not as bad as she had, it's not like intense with every single breathe, it's only if she take deep breath. She had the second shot of the vaccine on 17Feb2021 and got sicker faster after the second shot. The patient underwent lab tests and procedures which included haemoglobin: 14.6 on 04Feb2021, haemoglobin: 11.6 on 10Mar2021, red blood cell sedimentation rate: 48 on an unspecified date, white blood cell count: 16,600 on 04Feb2021, white blood cell count: 11,400 on 10Mar2021 and heart rate: higher on an unspecified date. Therapeutic measures were taken which included treatment with prednisone, flecainide, antibiotic for pneumonia and some kind of morphine pill for pain (given in the emergency room). On 24Mar2021, she had a cardioversion to try to deal with the tachycardia and in order to do that she had to take Eliquis. The outcome of erythrocyte sedimentation rate increased and white blood cell high was unknown and for the other events was not recovered. Information on Batch number/Lot number has been requested.
72 2021-05-13 chest pain This is a spontaneous report from a contactable other HCP (healthcare professional), the patient. A ... Read more
This is a spontaneous report from a contactable other HCP (healthcare professional), the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: E11283) via an unspecified route of administration on 19Dec2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included "HTH GERD" and sulfa allergy, both from unspecified dates and unspecified if ongoing Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within two weeks of the vaccination) included pantoprazole sodium sesquihydrate (PROTONIX), losartan and anastrazole, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received demerol for an unspecified indication on an unspecified date and experienced allergy (reported as "known allergies: Eli sulfa demerol"). On 08Jan2021 at 12:00 the patient experienced severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain. All events were serious for hospitalization on an unspecified date, for 5 days. All events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The events required treatment with antibiotics for 6 weeks. The clinical outcomes of the events severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain were all recovered/resolved with sequel (recovered with lasting effects) on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available the reported events more likely represent intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
73 2021-01-06 pallor Strong nausea, vomiting and pallor.
73 2021-01-07 chest discomfort 12:15 Client verbalize tightness with inhalation below the right breast. Client was evaluated by on... Read more
12:15 Client verbalize tightness with inhalation below the right breast. Client was evaluated by onsite paramedics and release to go home at 12:27 pm.
73 2021-01-14 hypotension Patient felt lightheaded upon standing when her observation period was over. She also may have sto... Read more
Patient felt lightheaded upon standing when her observation period was over. She also may have stood up too quickly, per pt. She reports a low BP in general. A bottle of water was given to patient; after drinking, she felt better. Her BP was 112/90. Her HR was 68. Patient reassured and felt better. She was given another bottle of water and walked around a bit with no symptoms. Patient left stable.
73 2021-01-14 hypotension Patient felt lightheaded upon standing when her observation period was over. She also may have stoo... Read more
Patient felt lightheaded upon standing when her observation period was over. She also may have stood up too quickly, per pt. She reports a low BP in general. A bottle of water was given to patient; after drinking, she felt better. Her BP was 112/90. Her HR was 68. Patient reassured and felt better. She was given another bottle of water and walked around a bit with no symptoms. Patient left stable.
73 2021-01-20 palpitations At 10:47 am client complained of nervousness and heart palpation. Client was attended by onsite EMS... Read more
At 10:47 am client complained of nervousness and heart palpation. Client was attended by onsite EMS and released home after stating she felt better.
73 2021-01-20 pallor She was feeling dizzy and feeling lightheaded so we gave her a glass of water. In 20 minutes she st... Read more
She was feeling dizzy and feeling lightheaded so we gave her a glass of water. In 20 minutes she started getting her color back. However, because at one point she had her head over her knees and drooling, we called 911 and the ambulance took her to the hospital.
73 2021-01-24 hypertension STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME... Read more
STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME WORDS, DIFFICULTY SIGNING NAME, HIGH bp WAS ADMINISTERED EMERGENCY CLOT BUSTING DRUG IV AND THEN TRANSFERRED TO NEUROLOGY HOSPITAL. SYMPTOMS OF SLURRED SPEECH, DISAPPEARED NEXT DAY, WRITING HAND RETURNED TO NORMAL RAPIDLY AFTER IV. SLIGHT HEADACHE REMAINED FOR A COUPLE OF DAYS
73 2021-01-25 heart rate increased, atrial fibrillation, hypertension Three hours after the vaccination, my heart started beating very rapidly. I went to the Urgent Cent... Read more
Three hours after the vaccination, my heart started beating very rapidly. I went to the Urgent Center and my heart rate was 161 and my blood pressure 174/113. When they gave me an EKG, I was in aFib. I was sent by ambulance to Hospital where another EKG, an xRay and some blood tests were taken. I was kept overnight and released the next afternoon after my blood pressure and heart rate was lower.
73 2021-01-28 hypertension 12-minutes after vaccination, the patient reported feeling lightheaded and dizzy. Patient was noted ... Read more
12-minutes after vaccination, the patient reported feeling lightheaded and dizzy. Patient was noted to be anxious and hypertensive. EMS managed care on-site and patient refused transport to hospital. Noted to be feeling improved prior to leaving facility.
73 2021-01-29 blood pressure increased Increase in BP
73 2021-01-31 blood pressure decreased, arrhythmia 2 bouts of PAT. Had not had arrhythmia since 48 hours after MI 8/18. Episodes caused pulse rate of ... Read more
2 bouts of PAT. Had not had arrhythmia since 48 hours after MI 8/18. Episodes caused pulse rate of 150 with drop io in BP to 86/50 and slight SOB. First episode lasted 5 min, second 3 min appox 10 min apart. Seemed to respond to carotid massage. Reported to cardiologist. (I am retired RN)
73 2021-01-31 chest discomfort Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjectiv... Read more
Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjective Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness,chest tightness, sweating, and feeling flushed She denied hives, loss of sensation, SOB. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress and tongue swelling. ALLERGY REVIEW OF SYSTEMS Previous Reactions: PCN Objective Vitals Vitals: 01/29/21 1514 01/29/21 1521 01/29/21 1526 01/29/21 1539 BP: (!) 153/97 (!) 154/116 (!) 167/90 (!) 172/84 Pulse: 59 64 59 55 SpO2: 99% 94% 96% 99% Blood Sugar 97 collected at 1500 Physical Exam No Rashes or Hives noted. No facial swelling , no wheezes. HEENT Pharynx is clear without exduate. No facial or tongue swelling. Lungs CTA all wheeze No SOB. Neck is supple. No swelling is noted. pt is anxious and nervous. No sign of anaphalyxis No stridor, no swelling Assessment/Plan Treatment included: antihistamines Benadryl 25 mg, Pepcid 10 mg Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Mild reaction, improving. Pt refused any further medications or assessment at the ER. Her husband will pick her up.
73 2021-01-31 palpitations, arrhythmia Within 5 minutes after the shot on Wednesday my heart started hammering in my chest. The EMT's were... Read more
Within 5 minutes after the shot on Wednesday my heart started hammering in my chest. The EMT's were called over and checked my pulse and blood pressure, and the arrythmia ceased after a few minutes. They said unless I wanted them to take me to the hospital I was OK to leave after the waiting period was up. Yesterday, Sunday Januart 31, I had a 2nd repeat episode of arrythmia which lasted a few minutes then went away.
73 2021-02-01 platelet count decreased 10 days after shot platelets have now dropped from 245000 to 94000; This is a spontaneous report fro... Read more
10 days after shot platelets have now dropped from 245000 to 94000; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) first dose on 08Jan2021 08:00 at single dose for covid-19 immunisation. The patient's medical history included thrombocytopenia. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 18Jan2021 11:00, ten days after shot platelets have now dropped from 245000 to 94000. The patient was very concerned platelets will drop below 30000 and will require hospitalization. The patient wanted guidance on what protocol to follow to avoid a further drop in platelets. No treatment was given to the event. The event resulted in emergency room visit physician office visit. The outcome of the event was not recovered. The patient underwent nasal swab on 18Jan2021, and the result was negative. Information on the lot/batch number has been requested.
73 2021-02-01 chest discomfort Low grade headache starting immediately after shot - continuing through present; Lethargy and sleepi... Read more
Low grade headache starting immediately after shot - continuing through present; Lethargy and sleepiness starting 1/30 and continuing to present; Deep chest cough and tightness in chest starting 2/2/21
73 2021-02-01 chest pain bad headache; a lot of muscle aches and pain; body aches from her toes to top of her head; arthritis... Read more
bad headache; a lot of muscle aches and pain; body aches from her toes to top of her head; arthritis that was acting up because it was cold; arthritis that was acting up because it was cold; chest hurts, left center of chest sharp pains; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via intramuscular route of administration on 13Jan2021 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included blood pressure and arthritis. Concomitant medications included unspecified blood pressure medications and some "probiotic type thing". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021, Thursday night, the patient had a lot of muscle aches and pain and has body aches from her toes to top of her head which were persisting. She thought it might be her arthritis that was acting up because it was cold but states it is more than that. Her chest also hurts, not constantly, towards the left center of her chest, what were like sharp pains but it was not normal. She is still having the chest pain, states it is not anything she can clock by time, it goes and comes back, only lasts a very short time, it hurts about a minute or two and then goes away. Last night (18Jan2021), she also developed a bad headache that went away when she slept but now that she is awake it is coming back. At the time of report, the outcome of the events not recovered. Information about lot/batch has been requested.
73 2021-02-02 loss of consciousness Had shot at 4:26pm Ate a light dinner(lentil soup and omelette) Woke up around 2:30 am felling naus... Read more
Had shot at 4:26pm Ate a light dinner(lentil soup and omelette) Woke up around 2:30 am felling nauseas and had diarhea and chills which continued through the night and following day. Very weak and passed out briefly when feeding my dogs.Ate a bland diet and drank plenty of water for the next few days. Felt better on Saturday January 30th
73 2021-02-03 hypertension, fainting As soon as I got the shot I felt ?strange? . all over. We waited a bit and then the nurse took my B... Read more
As soon as I got the shot I felt ?strange? . all over. We waited a bit and then the nurse took my BP. It was sky high. 210/180 They took it a couple of times and even changed machines. Then the took me in a wheelchair to the ER. On the way I could not answer some questions or my answers were slow. According to my husband I slumped a bit. And answered questions in my native tongue. In the room they did all kinds of tests. BP was still high, but came down . After a few hours my ?fog? in my head cleared and I felt ? normal ? again. They let me go around 11 pm. The doctor said it was NOT the vaccine, but I disagree with her. I felt good till I got the shot. She says I had a syncope vasovagal. But that occurs with low BP. I had high BP.
73 2021-02-03 chest discomfort Chest tightness/heaviness, fatigue, "rubber arms", temp 100.6,
73 2021-02-03 pallor, chest pain Client presented for 1st dose Pfizer Covid vaccination. 45 minutes after receiving vaccination clien... Read more
Client presented for 1st dose Pfizer Covid vaccination. 45 minutes after receiving vaccination client complained of Intermittent chest pain in Left Upper Chest. Pulse regular, strong rate of 68. Resp 20, regular. BP138/90. 911 called. Pt now complaint of jaw pain on left side and throat soreness. Client was pale with no sweating. Fidgeting in seat. At 10:48 am EMS arrived. Client immediately transported to Hospital.
73 2021-02-03 heart rate increased Heartbeat was elevated to 93, where it is normally 70 or 72/heartbeat intermittently going faster wh... Read more
Heartbeat was elevated to 93, where it is normally 70 or 72/heartbeat intermittently going faster when going up the stairs; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249; Expiration date was not reported) on 15Jan2021 at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 18Jan2021, the patient's heartbeat was elevated at 93 where it was normally 70 or 72. The patient' fast heartbeat was intermittently going faster when going up the stairs, and it was unusual for her. The outcome of the event, elevated heartbeat, was unknown.
73 2021-02-03 palpitations SHORTLY AFTER RECEIVING VACCINE, PT STARTED COMPLAINING OF PALPIATIONS AND LIGHT HEADNESS. PT TOOK G... Read more
SHORTLY AFTER RECEIVING VACCINE, PT STARTED COMPLAINING OF PALPIATIONS AND LIGHT HEADNESS. PT TOOK GLUCAGON TABLET SHE HAD BECAUSE SHE THOUGHT HER SUGAR WAS LOW. PT SYMPTOMS DID NOT IMPROVE. PT HAD HISTORY OF AFIB SO SHE WAS TRANSFERRED TO ER
73 2021-02-03 heart rate increased, oxygen saturation decreased the thermometer that marked 100°F orally (she says that the fever was higher in the night); States ... Read more
the thermometer that marked 100°F orally (she says that the fever was higher in the night); States she is shrinking. Weight varies; cough; 86 of oxygen saturation/O2 saturation was anywhere between 86-88; pulse was 133/rapid pulse, it was 133/rapid heartbeat; her breathing was above 94; shooting pain/stabbing pain at the injection site/extremely excruciating stabbing pains in her arm with the shot; shivers; headache/splitting headache; freezing; slight breathing difficulty; slight body aches; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), via an unspecified route of administration on 15Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included high blood pressure diagnosed 15 years ago, maybe; High cholesterol diagnosed 20 years ago, she doesn't know, reflux diagnosed 20 years ago, maybe more, prediabetes and allergy induced asthma which she carries an inhaler, and she has used it maybe three times a year. Patient reported that she was tested and they don't know for sure, but she reported that she may have allergy induced asthma as she has to take, carries an inhaler, and she has used it maybe three times a year, in the fall when leaves are falling down, the leaves get moldy, and she was driving in her car, or walking in a wooded area, she gets tightness, takes her inhaler and was fine, that's the extent, no other circumstances; fall or she had where a plant was blooming outdoors, she gets tightness, and she took her inhaler, and was good for the next year, so sitting in the environment and nothing further materializes, if she takes the inhaler three or two times a year, considering what other people have, she thought this was insignificant. There were no concomitant medications. The patient reported that she got vaccinated this Friday and had nothing but a sore arm afterwards, on 16Jan2021 and was fine all day, evening, all day Saturday. She just had soreness at the site, she had no redness at the site of injection, but the weird part: she doesn't think anyone would believe, 33 hours later, at midnight, she was still up, on her way to bed, and all of a sudden she experienced extremely excruciating stabbing pains in her arm with the shot, it was stabbing, excruciating, and immediately at the same time, she had shivers/shivered and had a splitting headache, was freezing and had to put socks on, and had noticed very slight difficulty breathing, and since it was midnight, she didn't want to wake up her husband, she dozed off, and was up at 0530. She had body aches, slight, it was the least, but the stabbing stopped in her arm. She slept from 12:30 to 05:30, and the shivering and aches stopped, but the headache was still on, so she took a pill for the headache. She took the thermometer that marked 100F orally; she stated that the fever was higher in the night and she assumed with the shivering, she had a greater fever than 100. Also, the oximeter indicated 133 pulse and 86 of oxygen saturation. By 10:00, it all had resolved. She has an oximeter, and since she still had the feeling of difficulty breathing, she put it on, but her pulse was 133, that was when she was feeling better. It was reported that all symptoms were gone except for rapid pulse, it was 133 and the slight breathing, and her 02 saturation was anywhere between 86-88, it varied, and by 10:00, all issues resolved, her heartbeat was down to normal, her breathing was above 94, or whatever, everything was fine, and has been fine since then. Maybe she had fatigue on Saturday and Sunday, on Sunday was like after the flu, after you finish, you have fatigue and was a little out of it, this was on Sunday. On an unspecified date, the patient stated that she was shrinking and weight varies. Patient stated that the only thing she does have, says she has a cough, but because she needs a drink, she was not sick and she gets to drink water. She felt like the reaction she had was in the limit of a severe allergic reaction due to the rapid heartbeat and her difficulty breathing. She would like to know if there was information about these side effects reported so she can determine if she was going to have the second dose of the vaccine. Outcome of events states she was shrinking, weight varies and cough was unknown; and outcome of the rest of events was recovered on an unspecified date.
73 2021-02-04 hypertension Left hand numbness approximately 15 min after vaccine on thr left deltoid. Pt was really anxious how... Read more
Left hand numbness approximately 15 min after vaccine on thr left deltoid. Pt was really anxious however the hand numbness improved after 20 mins of rest and relaxation. Initially pt was hypertensive however after resting BP improved
73 2021-02-04 low blood platelet count, platelet count decreased platelets dropped from 244,000 to 94,000/idiopathic thrombocytopenic purpura (ITP) for 5 years; plat... Read more
platelets dropped from 244,000 to 94,000/idiopathic thrombocytopenic purpura (ITP) for 5 years; platelets dropped from 244,000 to 94,000/idiopathic thrombocytopenic purpura (ITP) for 5 years; This is a spontaneous report from a contactable consumer (patient's spouse). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284 and expiry date: unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included high blood pressure and idiopathic thrombocytopenic purpura (ITP) for 5 years at a very severe level 4 years ago to the point she was hospitalized for 10 days and her platelets were almost count zero. Concomitant medication included amlodipine. It was reported that despite patient's condition, she has received multiple vaccines, mostly flu in the last 4 years, and had no problems. 11 days after the 1st dose, patient's platelets dropped from 244,000 to 94,000 on 18Jan2021. Patient consulted the hematologist and was prescribed with 20 mg of Prednisone. Then, after 14 days, his wife's platelets rose back up to 248,000 on 20Jan2021. Patient was scheduled to receive the 2nd dose of the vaccine a week from the time of report. Reporter to know if patient should still get the 2nd dose, and if there have been studies for people with ITP and the use of the vaccine. Patient had a rapid Covid test on Monday (18Jan2021) that came back negative and antibodies test on Monday afternoon. Outcome of the event was recovered.
73 2021-02-05 lightheadedness, hypertension Patient presented to the ED shortly after receiving her COVID vaccine with hypertension, altered men... Read more
Patient presented to the ED shortly after receiving her COVID vaccine with hypertension, altered mental status, and a near syncopal episode upon arrival at the ED. Patient also reported some throat tightness and nausea. Patient received the first does of the Pfizer COVID vaccine about one hour PTA. Patient began having hypertension noted to be in the 180-215 systolics and patient reports baseline of 120s systolic. Patient was brought directly from the vaccine clinic to the ED. Upon arrival at the ED, patient experienced a syncopal episode and eventually came out of this but was confused. It was reported in the notes that patient was slightly dehydrated which could have contributed to her symptoms. Once the patient recovered from this episode and hypertension was resolved, patient was discharged home to follow up with PCP.
73 2021-02-05 heart rate increased Temperature 101.3, severe headache, chills, fever, diarrhea, body aches, unable to move left arm, hi... Read more
Temperature 101.3, severe headache, chills, fever, diarrhea, body aches, unable to move left arm, high heart rate, difficulty breathing
73 2021-02-06 heart rate increased Within 15 minutes started feeling nauseous which has continued, varying in intensity, as I write thi... Read more
Within 15 minutes started feeling nauseous which has continued, varying in intensity, as I write this. Additionally today, suddenly I started feeling hot and weak. I checked my oxygen level which was fine at 98, but my pulse was fast at 115 when it is normally in the low to mid 70s and I was just cooking. When I took my blood pressure, it was 142 over 125 a blood pressure than is normal for me. I took a table of Inderal 10mg and within an hour my blood pressure was normal at 117 over 86. My pulse was also 73.. So for now I?m ok.
73 2021-02-07 heart rate increased Headache, muscle ache, joint ache, raised heart rate, difficulty breathing
73 2021-02-07 heart rate increased No reaction until 10pm. Injection site became sore and tender, Had chills during the night. Follo... Read more
No reaction until 10pm. Injection site became sore and tender, Had chills during the night. Following morning was running 102 degree temperature, heart rate was 107 and blood pressure was 90/60. Took two 650 mg tylenol and temperature was back to normal within 5 or 6 hours. Heartrate never got below 102 until late afternoon and blood pressure was still low at bedtime. Uneventful night and all was normal the following morning. No reaction since.
73 2021-02-07 blood pressure increased Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weir... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after reciving vaccination patient stated they "felt weird", reported nausea and shortness of breath, and were found to have a blood pressue of 200/96 mmHg despite taking blood pressure medications that day. Patient was transported to the emergency department during which they had a brief episode of unresponsiveness and were non-interactive. On initial exam in the emergency department patient symptoms were improving: speech, sensation, and cranial nerves are intact, normal strength in all extemities, lungs are clear, and there is movement in all extremities. No rash, wheezing, or respiratory distress noted. Repeat vitals within normal ranges except blood pressure 151/87. Patient administered medication for nausea. Symptoms resolved and patient discharged to home stable.
73 2021-02-07 heart rate increased, palpitations Ten minutes after receiving her vaccination she developed heart racing and pounding that was so seve... Read more
Ten minutes after receiving her vaccination she developed heart racing and pounding that was so severe she thought her heart would burst. It lasted for about five minutes, stopped for half a minute and then went on again for another 10-15 minutes. She was monitored by a nurse on site but does not know her vital signs. She did not have any chest pain, cough, wheezing, shortness of breath or hives, just a strong rapid heartbeat. No symptoms since then.
73 2021-02-07 blood pressure increased, heart rate increased she has probably shrunk in height; 5am on 21Jan2021, for the whole day i had a fast heart rate, 125b... Read more
she has probably shrunk in height; 5am on 21Jan2021, for the whole day i had a fast heart rate, 125bpm; blurry eyes; dizziness; Her blood pressure was also up; In the morning of the 20Jan2021 I was weak; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 19Jan2021 10:02 at a single dose for Covid-19 immunization. Medical history included ongoing Seasonal Allergies (probably started in the last 4-5 years; reoccurs every year from about Oct through Mar), ongoing high blood pressure since like 2006 or 2004, ongoing Iliac artery stent placed started couple of years ago, anxiety from 2010 and ongoing (her cardiologist put her on Xanax around 2010-ongoing). Concomitant medication included ongoing alprazolam (XANAX) since 2010 for anxiety. She gets the flu shot every year and has never had a problem with the flu shot. She got her last flu shot in Oct2020, no adverse events with that or other flu shots historically. On the second dose of Pneumococcal vaccine, it swelled her arm up from the injection site all the way down to her wrist; she went to the urgent care for that. They gave her some medicine and eventually the adverse event went away. She experienced some side effects following that injection. The patient reported that in the morning of the 20Jan2021, she was weak and just kind of rested. She did not have any other side effects until 21Jan2021. At 5am on 21Jan2021, for the whole day she had a fast heart rate, 125bpm, she woke up with her heart rate up, fast heartbeat, then down to 110 and then just toggled a little bit, she had blurry eyes so she could not really focus her eyes, weakness and dizziness. These events continued all throughout 21Jan2021 but her heart rate came down, it was running in the 90s and she was weak all day. Her blood pressure was also up on 21Jan2021. She thinks the blurry eyes, with her eyes being squirrely was related to her heart rate being up and blood pressure being up. She feels like she recovered completely from these events by this morning 22Jan2021. She feels good, strong and her eyes are clear today, felt better than yesterday but not 100%. She has probably shrunk in height, her last known height was 5' 9. She called to ask if she should or should not get the second dose as scheduled for 12Feb2021 in response to the side effects. Outcome of the event 'she has probably shrunk in height' was unknown while the rest of the events was recovered on 22Jan2021. No follow-up activities are needed. No further information is expected.
73 2021-02-08 chest pain, pulmonary embolism Two days after receiving the vaccine, on Jan 28th, I noticed pain in my right lower back area. It ... Read more
Two days after receiving the vaccine, on Jan 28th, I noticed pain in my right lower back area. It went away so I didn?t pay much attention to it. On Jan 29th, I woke up to stabbing pains in my right chest which continued to night of Jan 30th. Morning of Jan 31st, I was very short of breath and could hardly get around. I went to the ER in evening of Jan 31st. I was admitted due to two pulmonary embolisms in my lungs. Doctors were convinced I had Covid 19. However, three tests came up negative. I was put on a Heparin drip and then eventually on Eliquis. I have always been healthy up to this point and never had any clotting issues. I now am on Eliquis for at least six months (have to have a follow-on echocardiogram due to issues on right side of my heart.). I am convinced the vaccine triggered the clots.
73 2021-02-10 fainting, cerebrovascular accident, atrial fibrillation 1/21/2021, 48 hours after 1st dose, collapsed at home. Possibly triggered A Fib and went to ER with ... Read more
1/21/2021, 48 hours after 1st dose, collapsed at home. Possibly triggered A Fib and went to ER with BP 180/110. CVA verified by MRI of brain. Drs suggested that Pradaxa was not strong enough to prevent stroke when A Fib was triggered. Anticoagulant changed to Eliquis.
73 2021-02-10 chest discomfort Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited requi... Read more
Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited required 15 min. w/o reaction. Pt remained for husband's 15 minute wait. During this time, patient felt dizzy and nauseousl and generally weak at 1150. Nourishments provided without relief. Rapid response called at 1155. Team arrived assessed patient. VS179/81 82 pulse, O2 - 96%. Dr. from Urgent Care came to check patient. Told to observe patient and repeat VS, patient ok per Dr. VS repeated at 1215 - 185/92, pulse 84, O2 sat 98%. Patient with c/o pressure to chest, chills and hives. Patient remained stable, husband present. 911 called. EMS Station 28 B shift arrived at 1225 and assumed care of patient. 1245 Ambulance arrived Unit 217 assumed care of patient.
73 2021-02-10 blood pressure increased, lightheadedness She felt like she was passing out; Dizziness; Felt tingling of her tongue; Blood pressure was rising... Read more
She felt like she was passing out; Dizziness; Felt tingling of her tongue; Blood pressure was rising; She had tongue itching; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. This 73-year-old female consumer reported that she received 1st dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine; lot number FL1284) on 10Jan2021 1:00pm at left arm for COVID-19 immunization. Medical history included allergic to latex. Concomitant drugs included Atenolol for Blood pressure high from 2011, Furosemide from 2011 as Diuretic, Alprazolam from 2011 for Sleeping and anxiety, Simvastatin from 2011, all were ongoing. The patient experienced a reaction after the first dose on 10Jan2021 that she became dizzy and felt tingling of her tongue. Every 15 minutes they checked her blood pressure for an hour. Her blood pressure was going up slightly. She was monitored by fire rescue and her blood pressure was rising but not dangerously high. The fire rescue also checked her blood sugar (normal result) and other lab values and decided she did not need emergency room care and instructed her to take Benadryl when she got home. They felt she had a mild reaction. The patient stated the dizziness came in waves and she felt as if she was going to faint. The dizziness went in waves where she felt like she was passing out. The tingling on her tongue felt similar to the allergic reactions she has had in the past to latex but without swelling. She did not have tongue swelling. She had tongue itching. It was like having a reaction to the latex gloves when you go to the dentist. Her symptoms only lasted for two hours. After a total of 2.5 hours she had no symptoms. Dizziness, tingling, and elevated blood pressure initially that went away after taking Benadryl. She was scheduled to receive second dose on 31Jan2021. The events was resolved on 10Jan2021.
73 2021-02-14 hypertension Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood press... Read more
Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood pressure 193/94; shakiness; This is a spontaneous report from a contactable consumer (patient) reported for that a 73-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) , via an unspecified route of administration on 30Jan2021 14:30 at single dose at right arm for covid-19 immunisation. Medical history included blood pressure. Concomitant medication included pantoprazole, metoprolol, atorvastatin, metformin. The patient previously took Cefdinir and experienced allergy. The patient experienced dizziness with very high blood pressure 193/94, also shakiness, major headache on 30Jan2021 16:30. Adverse event result doctor or other healthcare professional office/clinic visit. The patient had EKG. Therapeutic measures were taken as a result of events included unspecified medication. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
73 2021-02-16 hypertension Approximately 36 hours after injection I became dizzy, could not sleep due to constant dizziness, o... Read more
Approximately 36 hours after injection I became dizzy, could not sleep due to constant dizziness, off-balance and found it difficult to rise from a sitting/laying position without being overcome by dizzy spells. Also felt slight tightness in my head. I begin to take my blood pressure which was well over what was normal for me. BP ranged from highest of 155/84 to 145/78. Blood pressure begin to lower as I begin to take my Blood Pressure medication doubling the dose from 5mg to 10mg Amlodipine. I also take the medication at night, versus my normal routine to take medication during the day. Not sure if this was just a coincident or precipitated by the vaccine.
73 2021-02-16 excessive bleeding Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joi... Read more
Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joint and muscular aches. Then progressed to persistent productive cough. No fever during this time. These symptoms lasted until 2/15/2021.
73 2021-02-17 palpitations hypokalemia; heart started pounding hard/diagnosed with heart palpitations and hypokalemia; This is ... Read more
hypokalemia; heart started pounding hard/diagnosed with heart palpitations and hypokalemia; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9262), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunization. Medical history included preexisting cardiac issues, she has heart arrhythmia, PAC's and PVC's (all ongoing). The patient's concomitant medications were not reported. On 01Feb2021, later that night (about 12 hours after vaccination), patient's heart started pounding hard. She stated that she has preexisting cardiac issues, she has heart arrhythmia and also has PAC's and PVC's. This is what she used to experience years ago before she was treated with medication. During event on 01Feb2021, EMT that came did EKG at the house, they were concerned about what was seen and patient was taken to Emergency Department and was given some medication to slow her heart rate down. Her EKG was "very erratic" and she was given Cardizem which resolved the issue quickly and was also given some Potassium chloride. Troponins and labs drawn on 01Feb2021. The patient was diagnosed with heart palpitations and hypokalemia. She received new cardiac home medications to take and referral to see Cardiologist next week. The patient was wondering if these were side effects from vaccine. Outcome of the events was unknown. The patient was hospitalized for the events.
73 2021-02-18 fainting Exactly 12 hours after the shot, I experienced a severe wave of nausea, dizziness, faintness, and bo... Read more
Exactly 12 hours after the shot, I experienced a severe wave of nausea, dizziness, faintness, and body sweats that lasted 15 minutes. It gradually subsided.
73 2021-02-18 hypotension, heart rate increased, heart rate irregular The day after my second Covid shot, while just standing still and with nothing to precipitate it, ha... Read more
The day after my second Covid shot, while just standing still and with nothing to precipitate it, had about 3 minutes of very rapid (~167) heartbeat with very strong heart movement in my chest. My heart rate is normally in the 60's, blood pressure low, no heart or health problems, and nothing like this has ever happened before. Within a few minutes, I felt fine and have not changed my regular exercise or anything else.
73 2021-02-21 cerebrovascular accident Acute thalamic cerebrovascular event
73 2021-02-22 loss of consciousness I had passed out hitting a table bumped head and back.; very dry mouth; felt very light headed; Thou... Read more
I had passed out hitting a table bumped head and back.; very dry mouth; felt very light headed; Thought maybe I may have been dehydrated; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at Left arm on 06Feb2021 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included High blood pressure. Concomitant medications included losartan, atorvastatin calcium (LIPITOR) and vitamins. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient woke up 1:30 am 07Feb2021very dry mouth, used restroom, felt very lightheaded, went back to room, next thing she heard was glass breaking. She had passed out hitting a table bumped head and back. Her boyfriend was with she helped she up. Said her legs went out from under her. Thought maybe she may have been dehydrated though she had drunk water throughout the day and before bedtime. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Feb2021.
73 2021-02-23 atrial fibrillation Feeling sick, AFIB occurrences, had a fever on 2nd day of 100.8, left shoulder hurt from shot and ju... Read more
Feeling sick, AFIB occurrences, had a fever on 2nd day of 100.8, left shoulder hurt from shot and just felt very bad all over!
73 2021-02-23 chest discomfort pt felt vague tingling in her head and then it went down to her feet. Initially on the R then resolv... Read more
pt felt vague tingling in her head and then it went down to her feet. Initially on the R then resolved then on the left then resolved. She also felt like her lungs were feeling weird. This gradually improved over the course of an hour.
73 2021-02-24 heart rate increased Approx 5 hours following Pfizer injection her heart beat was rapid and the right half of her tongue ... Read more
Approx 5 hours following Pfizer injection her heart beat was rapid and the right half of her tongue was swollen and red. No other symptoms, resolved without treatment 3 hours later. She notified her physician who recommended not taking the 2nd dose.
73 2021-02-24 fainting On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, ch... Read more
On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, chills, ear ache, pain level 8. Felt sick all over, like having the flu and then whole body ached, not just GI track. Left arm injection site was red, sore to touch, swollen (slightly). Doctor couldn't get vaccination needle into arm muscle the first time and so had to try a second time. Intense cramping of GI track started up again 8:45AM on Feb. 13th. By 4PM Feb. 15th fever 102F, chills, felt freezing cold and had to wrap myself in a heating blanket. Pain level 10, especially in pancreas. Fever broke around 2:30AM Feb. 16th and later when I was up at 8AM I felt very weak, faint, pancreas ached. Pancreatic pain lasted another 3 days. Pancreatic pain stayed around level 5. On Feb. 17th took ibuprophen. Pain level reduced to 1. This was the only time that I took pain medication between Feb. 10th and 17th, because I am conservative about using Ibuprophen, Tylenol, and have a high threshold for pain.
73 2021-02-24 excessive bleeding Progress Notes Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 ... Read more
Progress Notes Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 Date: 2/25/2021 Subjective is a 73 y.o. female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L arm/hand numbness . She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH: none per pt. Not on any medication. She has not been back to her pcp for "several years". No known hx of htn. She does have a bp cuff at home. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/25/21 1118 02/25/21 1136 BP: (!) 172/84 124/82 Pulse: 96 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. No sensory deficit. Motor: Motor function is intact. No weakness. Coordination: Coordination is intact. Coordination normal. Gait: Gait normal. Comments: +5/5 strength to upper and lower extremities. Equal facial movement. Psychiatric: Mood and Affect: Mood is anxious (slightly). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Exam is stable/unremarkable. VS improved after monitoring. Pt monitored for 20 minutes. She feels well. More like anxiety than local reaction. Pt aware of what to watch for. Education on monitoring bp at home and recommended that she follow up with pcp sometime next week to get up to date on her physical and follow up on bp records she will have done at home. Electronically Signed 2/25/2021 11:33 AM
73 2021-02-24 heart rate increased Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely t... Read more
Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely tired and sore arm that day. Day 2 - tired easily, no stamina. Dizzy and nauseous after showering at3:30 pm. By 10:30, both hands were red and itched. Sometime in the night woke with a very sharp, painful headache. Did not last. No real problem again until Saturday. Nausea at 11:20 am. Sunday I sat all day doing taxes - no symptoms noted. Monday after walking - rapid heart rate and very tired after what is normal activity. By 4:30 I was tingling all over my body. Tuesday night my ankles are swollen for the first time in years. Only happened that nigh. Wednesday morning, the tingling is very strong in my calves. and I had a sharp pain in the area of my Achilles tendon. I believe that the vaccine has exacerbated the neuropathy (undiagnosed) of the bottom of my feet. Today I am reporting because I fell for no reason getting out of a chair, and the tingling is in my legs, arms, shoulders. I had not heard until today that the vaccine could affect the nervous system. The effects are the worst they have been and it has been one week since I had the vaccine. Should I get the second shot? Due March 11,2021.
73 2021-02-24 blood pressure increased, heart rate decreased swelling of face and forehead, hot flashes. tremors pulse rate low, elvevated blood pressure
73 2021-02-25 nosebleed Patient was tired and slept for two days after vaccine. Then had nausea and general "blah" feeling ... Read more
Patient was tired and slept for two days after vaccine. Then had nausea and general "blah" feeling for the next 2 1/2 weeks and had nose bleeds. On Day 4 she did vomit. After second shot, she complained of constipation and aching on over. She vomited twice.
73 2021-02-26 hypertension Itching from head to toe; high blood pressure; flushed and warm
73 2021-02-27 low blood oxigenation, coughing up blood RECEIVED 1ST DOSE OF PFIZER COVID19 VACCINE ON 02/21/21. REPORTED TO ER ON 02/28/21 WITH SOA AND HEM... Read more
RECEIVED 1ST DOSE OF PFIZER COVID19 VACCINE ON 02/21/21. REPORTED TO ER ON 02/28/21 WITH SOA AND HEMOPTYSIS. DIAGNOSED WITH ATYPICAL PNEUMONIA, SHORTNESS OF BREATH, HYPOXIA, AND ELEVATED BNP. PLAN IS TO ADMIT TO HOSPITAL.
73 2021-02-27 chest discomfort, heart attack Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Ch... Read more
Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: DEATH-Severe, Systemic: Heart Attack-Severe
73 2021-02-28 heart rate irregular irregular heart beat; congestion in the chest; dizzy/the dizziness she was having and feeling now af... Read more
irregular heart beat; congestion in the chest; dizzy/the dizziness she was having and feeling now after getting the vaccine was definitely more noticeable; This is a spontaneous report from a contactable consumer (the patient). A 73-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left deltoid/ left upper arm in the shoulder on 26Jan2021 around 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: stroke about 4-5 years ago in June, dizziness, blood pressure. The patient also had difficulty writing stuff down; besides having a number issue, she had issues writing numbers down. Concomitant medication included apixaban (ELIQUIS) from an unspecified date and ongoing as a blood thinner. The patient stated she was on ten different medications. These medications were added after the stroke. Before the stroke she was not on any medication. The patient did not have any vaccines administered on same date of the Pfizer COVID vaccine. The patient got the pneumonia vaccine (unspecified), but thinks it was longer than 4 weeks before. She did not remember, but she believed it had been a month and a half to 2 months (at the age of 73-years-old) since getting the pneumonia vaccine for immunization. The patient had the COVID shot on Tuesday of this week (26Jan2021), and she didn't seem to have much of a reaction other than what they expected except at 21:00 that night, she got pretty dizzy. She was still dizzy now. It was enough for her to have to walk with a cane in order to try and keep herself leveled. She could not move quickly. She did not know why she had this reaction. She called her doctor the next day, and he did not understand why. She mentioned she was reading material and saw this could be a severe side effect/situation. The doctor mentioned they were trying to find out if it was related to the blood pressure. She wanted to know if this is part of the side effect, dizziness? When the patient was attempting to provide the zip code, she stated her mind was going blank and could not remember the zip code. She later found something with it written on it and provided those details. She explained she had a stroke when trying to provide her current age. She stated numbers are hard for her. She stated she would be 74 in March, and questioned how old that would make her now, she later confirmed as 73. She read information today about the COVID vaccine, and she saw that one should be cautious about the vaccine if have a bleeding disorder, and she commented she was on a blood thinner. She went to the doctor last week and mentioned she was having dizziness. She clarified she had dizziness before getting the COVID-19 vaccine. When she went to the doctor, they thought it was due to blood pressure as the problem. They changed her blood pressure medication by placing on a higher dose. Then she started having more dizziness, and the dose was taken back down to the dose she was on before. She also added, she has an irregular heartbeat (unspecified date). She went to the doctor because of congestion in the chest (unspecified date); that was why she went to the doctor. The doctor asked about dizziness and she said she was having a little. However, the dizziness she was having and feeling now after getting the vaccine was definitely more noticeable. The clinical outcome of dizzy was recovering (as reported). The outcome of the other events was unknown. Information on Lot/Batch number has been requested.
73 2021-03-02 chest discomfort I am an asthmatic. Fine until 25 mins. after vaccine then tightness in chest that lasted about 45-6... Read more
I am an asthmatic. Fine until 25 mins. after vaccine then tightness in chest that lasted about 45-60 mins. Next day asthma had started.; I am an asthmatic. Fine until 25 mins. after vaccine then tightness in chest that lasted about 45-60 mins. Next day asthma had started.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: LL3248, expiry date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:00 at single dose for COVID-19 immunization. Medical history included allergies, chronic asthma, immune deficiency, high blood pressure, allergic to injections and infusions. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 25Jan2021 09:00, the patient stated that she was an asthmatic. She was fine until 25 mins. After vaccine, she then experienced tightness in chest that lasted about 45-60 mins. On the next day, asthma had started. She had the vaccine on Monday, and called her physician and requested to come to be checked which she did. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. Therapeutic measure was taken for the events that included Symbicort inhaler. Clinical outcome of the events was recovering.
73 2021-03-02 coughing up blood When I cough it was blood in that cough couple of times; Left leg swell up from my feet to all the w... Read more
When I cough it was blood in that cough couple of times; Left leg swell up from my feet to all the way up; When I woke up, I didn't know what time, what date, nothing; I was all confused; Feeling achy/ body ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL347, via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization at a health department because she was at high risk and she was 73. Medical history was not reported. Concomitant medications included unspecified medications. The patient had an injection done 2 weeks, not this last Friday, the Friday before that. They had to make her wait for half an hour before she left and she was okay. Then Saturday (23Jan2021), she started feeling achy but to she was okay. Then Sunday (24Jan2021), she had a very bad experience, she went and start watching TV and she fell asleep. When she woke up, she didn't know what time, what date, nothing. And she looked at the time on her TV and it said 6:45, she didn't know if it was am or pm. And it was dark outside and she didn't know if it was Monday or Sunday. She was all confused, she called someone to make sure what day and time and all and still she was still confused. And then she had to call her aunt and then she told her no it's Sunday and it's night time and so on. Then she got better. Then during the week she didn't have that much body ache, she expected that because that was in that papers. Then today is Sunday, Friday morning (29Jan2021) she got up and she coughed, when she coughed it was blood in that cough couple of times. Then her daughter came over and took her to the hospital (hospitalization details were not clarified). She had lab work the day they took her in the emergency room. At the hospital, they did all kind of tests, on top of that her leg, her left leg swelled up from her feet to all the way up, all the way up. They thought that it could have been some blood clot. And they took test and all and nothing, everything was okay. They couldn't find out why her whole leg was swollen. On top of that, they did chest x-ray and they did something else she can't remember, another test. And they took all kind of blood work and all. And they did to see if she had the virus, the COVID. And yesterday they called her from the hospital and they said that she didn't have the virus. And she asked them about the blood work and they told her if there was anything more than they would call her. So, she thinks all this came from that injection. She called because this was not guaranteed if this was from injection. When confirmed that COVID test was negative and blood work report was not out, she stated they haven't called her that meant her blood work was okay. The swollen leg has been gone down and blood once in a while she sees a little bit. They gave her 2 prescriptions, one was antibiotic and one is steroid. Due date for the next shot is 12Feb2021. The outcome of the events was recovering.
73 2021-03-03 palpitations Heart skipping and racing for apx. 2 hours after vaccination. Headache Low grade fever Body ac... Read more
Heart skipping and racing for apx. 2 hours after vaccination. Headache Low grade fever Body aches. Pain in all bone including ankles, fingers, and toes and arches
73 2021-03-07 palpitations, chest pain Pt reports to emergency department with complaints of chest pain and palpitations
73 2021-03-08 fast heart rate 73 yo F with renal mass was given her second Covid-19 vaccine IM in her right deltoid (lot# EN6206) ... Read more
73 yo F with renal mass was given her second Covid-19 vaccine IM in her right deltoid (lot# EN6206) on 3/4 at 1312. In the final minutes of this patient's 15 minute observation period, patient was noticed to have pulled her mask down and was looking at the observer as if she wanted to say something. Observer asked pt if she was ok. Patient nodded yes. A minute later, the patient dropped her purse and mumbled something. Patient's arm went up and patient became stiff and started seizing. Observer immediately called for help. Vitals, glucose and oxygen was placed on patient. EMS was called. Provider notified and went to patient who was sitting upright in chair actively having bilateral generalized
73 2021-03-08 heart flutter After receiving her vaccine client stated that she felt her heart fluttering. Vital signs obtained ... Read more
After receiving her vaccine client stated that she felt her heart fluttering. Vital signs obtained by Paramedics. BP 133/80, HR 64, O2 sat 100%. Client states she feels better. Discharged home by Paramedics.
73 2021-03-08 chest discomfort Chills, fever 101, Body aches, fatigue, Headache, nausea, swollen glands, SOB. started on 2/27 gradu... Read more
Chills, fever 101, Body aches, fatigue, Headache, nausea, swollen glands, SOB. started on 2/27 gradually improved and then a week later on 3/6/21 experienced body aches, chills , fever, chest tightness, headache which has resolved by 3/8/21..
73 2021-03-08 pulmonary embolism, fast heart rate, fibrin d dimer increased, low blood oxigenation Patient developed left sided pleuritic chest pain and dyspnea on 3/8 in the evening. She presented t... Read more
Patient developed left sided pleuritic chest pain and dyspnea on 3/8 in the evening. She presented to the ED 3/9 and was found to have a segmental left lower lobe pulmonary embolism (left lateral basilar segment) with associated LLL pulmonary infarction. She had tachycardia to low 110s, mild hypoxia to 89% on room air with no evidence of pneumonia or typical COVID infiltrates. She had no known COVID exposure. She had one prior pulmonary embolism in 1999 treated for 6 months with coumadin, and was subsequently found in 2000 to be heterozygous for Factor V Leiden. She is being admitted to the hospital for treatment of pulmonary embolism.
73 2021-03-09 heart rate increased Feeling of elevated heart rate, tired. BP 148/77, HR 98, O2sat 96. Denies chest pain, shortness of b... Read more
Feeling of elevated heart rate, tired. BP 148/77, HR 98, O2sat 96. Denies chest pain, shortness of breath, headache, dizziness. Palpitations resolved. Discharged in stable condition.
73 2021-03-09 ischemic chest pain Pain in my heart. Lasted 15 minutes. Took zanax and it went away. Also very bad trembling in my ha... Read more
Pain in my heart. Lasted 15 minutes. Took zanax and it went away. Also very bad trembling in my hands. Worse than usual.
73 2021-03-10 chest discomfort Vague chest tightness and tickle in her throat. .Improved with albuterol treatment. Hx of nausea w... Read more
Vague chest tightness and tickle in her throat. .Improved with albuterol treatment. Hx of nausea with PEG - no anaphylaxis with PEG.
73 2021-03-10 chest discomfort patient experienced tightness in chest and difficulty breathing, requested staff call 911 for squad.... Read more
patient experienced tightness in chest and difficulty breathing, requested staff call 911 for squad. Did not want to have personal EPI pen administered. EMS arrived 10 minutes after onset and was taken to ER. Rec'd call from pt. at vaccine site on 3/11/21 (day after vaccine administration) stating she was given EPI 3x in ambulance and transferred to ICU.
73 2021-03-11 blood pressure increased The day after receiving the vaccine, in the evening, the patient noticed her blood pressure was elev... Read more
The day after receiving the vaccine, in the evening, the patient noticed her blood pressure was elevated, she had muscle fatigue (both arms and both legs felt very "heavy"), and she felt as though she might faint but has yet to have a syncopal episode.
73 2021-03-11 chest discomfort Tingling in chest. Chest tight. VSS. Observed and symptoms resolved within 20 minutes. Released hom... Read more
Tingling in chest. Chest tight. VSS. Observed and symptoms resolved within 20 minutes. Released home
73 2021-03-11 heart rate increased numbness to right arm following injection that has subsided but has left pain in the deltoid and rig... Read more
numbness to right arm following injection that has subsided but has left pain in the deltoid and right wrist. also noted elevated heart rate after leaving the clinic. refuses to go to pcp due to risk of COVID
73 2021-03-12 hypotension Nausea, Sudden vomiting, extremely low blood pressure, and then started having a seizure... no previ... Read more
Nausea, Sudden vomiting, extremely low blood pressure, and then started having a seizure... no previous seizures or seizure disorders.
73 2021-03-13 low blood oxigenation Presented with fever and hypoxia - determined to be SIRS. No infectious source found. Other symptom... Read more
Presented with fever and hypoxia - determined to be SIRS. No infectious source found. Other symptoms included confusion, lethargy, aches, headache and fever.
73 2021-03-13 chest pain, low blood oxigenation Shortness of Breath, Orthopnea, chest pain, hypoxia Hospitalized as inpatient at Hospital *Electr... Read more
Shortness of Breath, Orthopnea, chest pain, hypoxia Hospitalized as inpatient at Hospital *Electronic form was not allowing form to give this information in section 21
73 2021-03-14 chest pain L arm/hand numbness; blood pressure abnormality; chest pain; respiratory distress; This is a spontan... Read more
L arm/hand numbness; blood pressure abnormality; chest pain; respiratory distress; This is a spontaneous report from a non-contactable other-HCP. This other HCP reported for a 73-Years-Old (same age at vaccination) female patient that she received the first dose of bnt162b2 (BNT162B2, Lot number EN6205), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medication was none. She had not been back to her pcp for "several years". No known history of HTN. She did have a blood pressure cuff at home. During her 15-minute waiting period after the injection on an unspecified date, the patient began to experience L arm/hand numbness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, rapid progression of symptoms and respiratory distress. Treatment included: no therapy. Follow up response was excellent. Patient discharge: stable to go home and follow up with PCP. Outcome of events was unknown. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on the information provided, and on a close drug-event temporal association, the Company assessed there was a reasonable possibility that the reported serious events were related to the suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
73 2021-03-16 heart rate increased 11 hours after my shot I was lying in bed trying to sleep. I noticed that my pulse rate was very fa... Read more
11 hours after my shot I was lying in bed trying to sleep. I noticed that my pulse rate was very fast. I measured it using a stop watch. It was 105 / minute. My normal is around 60. I had no other symptoms. I took Alprazolem 5 mg and after 20 minutes my pulse slowed down. After an hour it went to 75. I fell asleep and was fine in the morning.
73 2021-03-16 fast heart rate Fever, Chills, Vomiting, Weakness, Tired, Rapid Heartrate
73 2021-03-16 palpitations Light headed Hard to focus Heart pounding and racing to the point I thought I was going to pass out.... Read more
Light headed Hard to focus Heart pounding and racing to the point I thought I was going to pass out. It lasted two hours I did not feel normal for 4 days
73 2021-03-17 anaemia, pulmonary embolism Extremely tired for the next month, and then was hospitalized with 2 blood clots in lungs and severe... Read more
Extremely tired for the next month, and then was hospitalized with 2 blood clots in lungs and severe anemia (cause not determined yet, as to whether not making platelets or losing blood). Had two blood transfusions and iron transfusion.
73 2021-03-17 chest pain Pt. stated she started feeling a burning sensation 5 minutes after getting vaccinated, the burning s... Read more
Pt. stated she started feeling a burning sensation 5 minutes after getting vaccinated, the burning sensation moved to her chest and then to her legs and it went away on its own. At 10:47 am pt. stated she is feeling OK and wants to go home.
73 2021-03-18 chest pain Injection 2: day one: slight fever, chills, extreme muscle pain in both arms, legs and feet, head... Read more
Injection 2: day one: slight fever, chills, extreme muscle pain in both arms, legs and feet, headache, chest pain. First day. Injection 1: day one thru day three. Same as injection one. Headache was severe all three days.
73 2021-03-18 blood pressure increased Swelling of right hand including sore joints in wrist and fingers. This resolved by 3/1/2021. Hot ... Read more
Swelling of right hand including sore joints in wrist and fingers. This resolved by 3/1/2021. Hot flashes including drenching sweat , red neck and face and raised blood pressure. This occurred randomly. It was an almost daily event until 3/5/2021. This then reduced to 1 event every 2-3 days until the present. Last occurred on 3/18/2021.
73 2021-03-18 transient ischaemic attack TIA; I felt really lousy; This is a spontaneous report from a contactable consumer (patient). A 73-y... Read more
TIA; I felt really lousy; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), dose 2 at the age of 73-year-old, via an unspecified route of administration on 26Feb2021 as single dose for COVID-19 immunisation. Medical history included high blood pressure (don't have really high blood pressure but the doctor has her on blood pressure medicine, have no diabetes or whatever, and had allergies. Concomitant medication included amlodipine besylate 5 mg, taken every morning. She takes most of her medicines in the morning and had taken that stuff at about 5 o'clock or so early in the morning. The patient was previously vaccinated with the first dose of BNT162B2 on 05Feb2021 at the age of 73-year-old and hand no problem. The patient stated that when she had the first COVID vaccination she had no problem and then Friday she went to get the second one, it was 3 weeks later, when she had first one she stated that she had allergies, so they had her wait 15 minutes, no problem. When she went for the second one, thankfully someone drove her that was outside the 'game court' location. When they gave it they said, she pull up and will let her know after she pull up and will decide if she has to wait 15 minutes or 30 minutes and they asked her if she had allergies, and she said yes, they said pull over here and she has to wait 30 minutes and all she know was, it's probably 2 minutes from the time she got the vaccine until she got to the place to wait. She would say 15 minutes after she got it on 26Feb2021, she felt really lousy and told her friend, they 'said' she was having a Trans Ischemic Attack (TIA), and took me to the hospital and everything. An ambulance was called on 26Feb2021 at around 8 o'clock that morning, right after she had the vaccine and carried her straight in the hospital. She was discharged the next day 27Feb2021 at about 7 PM. The patient had a CT scan of her brain, MRI of her brain, and then cardial, something with reference to her heart, she forgot, all with unknown results. The body weight right now was about 150 pounds. The outcome of the events was unknown.
73 2021-03-19 heart flutter, pulse abnormal, heart rate irregular, blood pressure increased 5 min post shot had tingling around lips lasted 3-5 minutes . 8 hrs after shot - at rest - heart fl... Read more
5 min post shot had tingling around lips lasted 3-5 minutes . 8 hrs after shot - at rest - heart fluttering - Bounding pulses - restlessness - felt 1-2 irregular beats per minute - heart rate My Normal at 90-100. Lasted 3 hours Still continues periodically thru the day / Even at rest - restlessness continues/ BP elevated at doctors office yesterday 3/18/2021. EKG in office report says abnormal. SVT and Other changes. Haltor monitor and echocardiogram ordered And first available scheduled for 3./25/2021. Scheduled cardiologist for 4/12.2021.
73 2021-03-19 palpitations, hypertension High blood pressure (190/70) Painful headache due to high blood pressure Heart palpitations Hives on... Read more
High blood pressure (190/70) Painful headache due to high blood pressure Heart palpitations Hives on left arm above elbow
73 2021-03-19 heart rate increased INCREASED HEAR RATE NERVOUSNESS TROUBLE BREATHING
73 2021-03-20 fast heart rate tachycardia lasted 10-15 mins; This is a spontaneous report from a contactable physician. A 73-years... Read more
tachycardia lasted 10-15 mins; This is a spontaneous report from a contactable physician. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), dose 1st, parenteral on 15Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient first dose of the Pfizer covid vaccine on the 15Jan2021, right after the injection, patient experienced tachycardia lasted 10-15 mins, Patient informed the doctor about this on 19Jan2021. No other symptoms of anaphylactic reaction. The reporter enquired if any isolated tachycardia event with covid vaccine and if it was safe to give second covid shot. The outcome of the event was unknown.
73 2021-03-21 haemoglobin decreased, low blood platelet count, platelet count decreased History of present illness: patientt is a 73 y.o. year old female with a history of hypothyroidism, ... Read more
History of present illness: patientt is a 73 y.o. year old female with a history of hypothyroidism, hypertension, history of breast cancer status post bilateral mastectomies who presented with complaints of bruising, petechial rash and gum bleeds. She noticed that when she was brushing her teeth this morning, her gums were bleeding and found a pea size hematoma in the bottom of her lip. Denies recent injury or trauma. Denies fevers chills nausea vomiting chest pain shortness of breath cough weakness dizziness lightheadedness. Denies hematuria or blood in stools or dark stools. Patient reports she received her first dose of Covid vaccine on March 2. She noticed a large bruise in her injection site this morning. Denies pain. She reports that her lower extremity started itching last week and she began scratching and knows it is small red dots diffusely distributed in her bilateral lower extremities. Denies starting any new medications. Denies history of HIV or hep C. She reports starting a new topical medication given to her by a dermatologist for dry skin but does not know the name. Denies history of blood disorders. 3/18: Patient diagnosed with idiopathic thrombocytopenia and admitted to medical floor. History of present illness as above. Plt <2; WBC 9.2; Hgb/Hct 13.2/38 3/19: Oncology provider consulted and recommended oral prednisone 100 mg daily, transfusing for any evidence of significant bleeding and considering IVIG if no improvement in platelets after 2 days. After further discussion plan was changed to dexamethasone 40 mg dailys x 4 days and rechecking CBC, transfusing platelets if <2 with a goal of >10. Labs showed plt <2, transfused 1 units, plt increased to 9, transfused additional unit. Plt <2, <2, transfused 1 unit plt, increased to 9, transfused additional unit of plt. WBC 94.6, 10.1, 13.4 (no s/s infection, monitored); Hgb/Hct 13.1/38, 12.8/37, 11.7/33 (decreased throughout day). 3/20: Provider consulted hematology who recommended rechecking platelets in 24 hours and considering IVIG on 3/21. Continued dexamethasone. Platelets increased to 11 after additional plt transfusion on 3/19. WBC 15 (no s/s infection, monitored); Hgb/Hct 11.3/32. 3/21: Platelets found to be <2 with morning labs. Transfused 1 unit of platelets, IVIG ordered by hematologist, and dexamethasone was continued. Plt <2, transfused 1 unit plt, plt increased to 21. WBC 14.2, 17.5 (no s/s infection, monitored); Hgb/Hct 11.3/34, 13.2/38 3/22: Patient feels more comfortable this morning denying any new bleeding symptoms. ITP refractory to treatment with prenisone, high-dose dexamethasone and is status post 1 dose of IVIG. Patient to receive her last dose of dexamethasone today and reassess tomorrow. Additional dose of IVIG planned for 3/22. Plt 2 in the am, increased to 43 in the afternoon. WBC 11.5, 13.7 (no s/s infection, monitored); Hgb/Hct 11.2/33, 12.8/37 Patient is still currently admitted.
73 2021-03-21 fainting Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm.... Read more
Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm. At 2:am next morning, March 17, sudden severe nausea and diarrhea, severe headache, hot flashes and sweats continued for 2 hours. Intermittent syncope twice.
73 2021-03-22 low blood platelet count ITP
73 2021-03-23 hypertension I had the shot given this morning around 10:15 about 3:30 PM I cold tell my blood pressure was up so... Read more
I had the shot given this morning around 10:15 about 3:30 PM I cold tell my blood pressure was up so started monitoring 159/86 took at 4 PM 174/89 then at 430 171/102, CNP my family "Dr." had wrote a script for 7 Clonidine 0.1 mg pills for in case of emergency of my BP going to 170 as it had once in her office. I took the 1 pill and called to her. Laid down and rested no tv, no music and within an hour it was back down first 146/76 then hour later 134/62.
73 2021-03-23 blood pressure fluctuation Spike in blood pressure and numbness/tingling down arm within minutes after the injection. The follo... Read more
Spike in blood pressure and numbness/tingling down arm within minutes after the injection. The following morning, swelling on face and jaw as well as inside and around the mouth, including the tongue. Took Benadryl to relieve symptoms.
73 2021-03-24 heart attack Heart attack; she might have a little bit of heart cell damage; tired; This is a spontaneous report ... Read more
Heart attack; she might have a little bit of heart cell damage; tired; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN6207, Expiration date: Jul2021, NDC number was unknown), via an unspecified route of administration, in right deltoid on 10Mar2021 14:10 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history relevant to adverse event was not provided. The patient received historical vaccine of first dose bnt162b2 (Lot number: EL9267, Expiration date: May2021) right deltoid on 12Feb2021 for covid-19 immunisation. Patient did not receive prior Vaccinations (within 4 weeks). Caller is a retired Registered Nurse who states she felt it was important to report, that she had a heart attack 70 hours after receiving the Covid vaccine on 13Mar2021. Her doctor informed her she probably should report it. Caller states she's not 100 % sure it's the Covid vaccine. Informs she has no other cardiac issues, health issues or problems with medications, stating they narrowed it down. Patient was taken by ambulance and then to the Emergency Room. States she was admitted to the hospital and had testing done on heart, stress test echo, on heparin IV drip, aspirin. Hospitalized for 4 days. Patient states supposedly she will have a complete recovery, right now she is just tired. Was told she might have a little bit of heart cell damage on an unspecified date in Mar2021, but not anything really significantly. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. As per the reporter for the heart attack seriousness criteria reported as Life threatening and Caused/prolonged hospitalization. patient was in hospital for Heart attack from 13Mar2021 to 16Mar2021. As per the reporter drug result reporter as related. The patient underwent lab tests and procedures which included testing done on heart and stress test echo with unknown results in 2021. Therapeutic measures were taken as a result of heart attack. The outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile, there is possibility of causal association between the reported events Heart attack,Heart injury and the suspect vaccine BNT162B2 cannot be Excluded.Also there is limited information in the case provided,Consider also possible contributory effects from patient's medical history and surgical history.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
73 2021-03-24 chest discomfort one day of fatigue, then 2 1/2 weeks later sore muscles, chills, headache, tight chest. Fever develo... Read more
one day of fatigue, then 2 1/2 weeks later sore muscles, chills, headache, tight chest. Fever developed. Subsiding now at 3 1/2 weeks.
73 2021-03-25 heart rate increased Increased heart rate at time of shot and increased resting heart rate and increased heart rate dur... Read more
Increased heart rate at time of shot and increased resting heart rate and increased heart rate during daily activities going forward since shot resting heart rate before shot was 68-72 now 84-89 and upon regular activities 98 -110 or more depending on activities. Went to cardiologist and was told not in afib at the time of visit.. I don?t want second shot because I fear that this first one effected my heart adversely.
73 2021-03-25 loss of consciousness, fainting Patient fainted, was losing consciousness, she complained she was cold
73 2021-03-25 loss of consciousness, fainting Patient fainted, coming in and out of consciousness, complained that she feels cold
73 2021-03-25 hypertension Shortness of breath, tiredness, anxiety. BPs 145/65 (pulse 68), 121/63 (pulse 66). O2 sats 94% to 95... Read more
Shortness of breath, tiredness, anxiety. BPs 145/65 (pulse 68), 121/63 (pulse 66). O2 sats 94% to 95%. Had a rough morning and was a bit anxious. Let the patient vent about her day - SOB resolved.
73 2021-03-26 chest discomfort, loss of consciousness After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 day... Read more
After 12 hrs. neuropathy in feet and torso, shortness of breath, chest tightness continued for 3 days went to urgent care checked out OK but symptoms persist to this day. On 3/13 severe dizziness and vomiting and blacking out and went to ER. Admitted overnight. Pulmonologist prescribed course of Prednisone on 3/15 and ending on 3/25. Some relief for chest tightness Neuropathy has gotten steadily worse with inclusion of face and lower leg. On 4th day began some ringing in ears which is to this day louder. Have fatiugue, sleep issues, trouble focusing my brain and eyes. Everything is worse today. Can't hold my head up. Will someone please help me
73 2021-03-26 heart attack, palpitations Heart Attack: taken by ambulance to hospital ER: symptoms were weakness, pounding, racing heart, un... Read more
Heart Attack: taken by ambulance to hospital ER: symptoms were weakness, pounding, racing heart, uncontrollable shaking
73 2021-03-26 fainting, lightheadedness, excessive bleeding, very slow heart rate Pfizer COVID-19 EUA Vaccine Pt received first COVID vaccine 2/25/21. Tested positive for COVID late... Read more
Pfizer COVID-19 EUA Vaccine Pt received first COVID vaccine 2/25/21. Tested positive for COVID late February. Reported to ED 3/5/21 with near syncope. Patient was seen emergency department laying in bed. The patient had a noticeable scalp laceration to posterior parietal area. After being symptomatic with COVID-19 for a few days, the patient reports getting up at 5:00 a.m. to use the bathroom, feeling lightheaded, then ended up on the floor, she reports sitting on the floor and then hit her head at some point, but was not entirely sure of this timeline. She states she ended up moving to the living room when she noticed that her head was bleeding a lot and her fiance called 911. She reports a history of syncopal episode in 2001 when she had influenza and apparently the story was much the same as this time, but she actually lost consciousness in 2001. Admitted to observation. 3/7: 73-year-old female recent COVID-19 infection admitted on 03/05/2021 for an episode of syncope probably secondary to bradycardia versus volume depletion. Paramedic on arrival at home reported bradycardia with heart rate in the 30s but has been normal since admission. The CT angiogram of the chest done at the emergency room showed bilateral infiltrates compatible with recent COVID-19 infection. No PE. However patient has no respiratory symptoms and O2 saturation is perfectly normal. Urinalysis was suggestive of infection and subsequent culture was positive for E coli and it is pansensitive. She was admitted to hospital for overnight observation. She was commenced on IV Rocephin and azithromycin. The EP cardiologist was consulted and she recommended and echocardiogram and it revealed mild global hypokinesis with LVEF of 45-50% but patient denied any prior history of cardiac problem. On re-evaluation this morning the vital signs remains normal. Patient has not had any episode of bradycardia since she presented to the emergency room. She will be discharged home follow up with the EP cardiologist for further evaluation. Patient does not need outpatient oral antibiotics as IV Rocephin for 3 days should be adequate for uncomplicated UTI.
73 2021-03-28 fainting, hypertension Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high bl... Read more
Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high blood pressure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 02Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included hypertension and PCN allergies (penicillin allergy). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccine in four weeks. Concomitant medication included unspecified medication. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on Jan2021 15:15 as a single dose for covid-19 immunization. On 25Feb2021 06:00 PM, the patient was very tired, low energy (it has been almost 3 weeks), had one fainting episode though the patient doesn't know if it was related, and problems with high blood pressure. The fainting episode is reported, the other problems have been ongoing since second shot. The events required emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure was high on 25Feb2021 and nasal swab (sars-cov-2 test) was negative on 22Feb2021. The outcome of the events was recovering. Information on the lot/batch number for first dose has been requested.
73 2021-03-28 pulmonary embolism bilateral pulmonary emboli; ER ultrasound of legs (no clots); CT scan showed PEs; administered 2 sh... Read more
bilateral pulmonary emboli; ER ultrasound of legs (no clots); CT scan showed PEs; administered 2 shots Lovenox; Rx 10 mg Eliquis 2x/day for 1 week, then 5 mg 2x/day.
73 2021-03-28 blood pressure increased within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itc... Read more
within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itch; blood pressure: 178/90; within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itch; This is a spontaneous report from a contactable other health professional (patient). A 73-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 73-years-old, administered in Arm Left on 25Jan2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included one kidney, left was removed due to cancer, no residual cancer, allergic to juniper. The patient was not pregnant. Concomitant medication included ezetimibe (ZETIA), escitalopram oxalate (LEXAPRO), pravastatin (PRAVASTATIN), and probiotics; all taken for an unspecified indication, start and stop date were not reported. Patient reported that, "Within 8-10 minutes of shot, I began to sweat under my arms, my chest and back and head began to itch. EMT took my blood pressure: 178/90, oxygen level was good. They called the EMT Ambulance, and transported me to the medical center > they treated me with IV Benadryl and steroids and I went home within two hours, with no further issues." The events started on 25Jan2021 12:00 PM. The adverse events resulted in Emergency room/department or urgent care, Hospitalization (0 days). The patient received IV Benadryl, steroids and prescription for Medrol for events. The patient underwent lab tests and procedures which included blood pressure measurement: 178/90 on 25Jan2021, oxygen saturation: good on 25Jan2021. The patient recovered on 25Jan2021 14:00. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination. Facility type vaccine was Health Clinic/Facility. At the advice of her allergist she declined to get the 2nd dose of the Pfizer vaccine. Her questions is should she take a the J&J vaccine and wanted to know if Pfizer could give guidance on the matter. Information about lot/batch number has been requested.; Sender's Comments: Based temporal association, the reported events in relation to suspected drug BNT 162b2 cannot be totally excluded. Case will be reassessed pending new information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
73 2021-03-29 heart rate increased, oxygen saturation decreased Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurt... Read more
Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurts; This is a spontaneous report from a contactable consumer via medical information team.A 73-years-old female patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number :unknown) via an unspecified route of in Arm Right on 04Feb2021 07.00 as single dose for covid-19 immunisation. Medical history included asthma from 1971 , oesophageal spasm from 1981, diverticulitis ,concussion syndrome, anaphylactic shock .She has had anaphylactic shocks 4 times in her life. Concomitant medication included fluticasone propionate/ salmeterol xinafoate (ADVAIR) taken for asthma, fluticasone propionate/salmeterol (WIXELA INHUB) taken for asthma. On 04Feb2021 the patient stated couldn't get out of bed. On 09Feb2021 the patient experienced oxygen level decreased, heart rate increased. In Feb2021 patient experienced tired , dizziness and joints hurts.It was reported that She didn't have any anaphylactic shock after the COVID-19 vaccine. She had no reaction. After receiving the vaccine, she sat there with her husband for half an hour. In fact, nothing was wrong with her for 2 hours after receiving the vaccine. Then all of a sudden later on that day, she couldn't get out of bed. It was like she was sleeping, but wasn't sleeping. This lasted from Thursday around 11 a.m. until Monday, that kind of thing. She went to the doctor that Tuesday because she had her physical already scheduled .When she went to the doctor, it was determined her heartrate was 120. Her heartrate sitting or resting is usually in the 80's. Then, her heartrate was 120's four days after the vaccine. She didn't realize a racing heartrate was one of the severe effects of the vaccine. She didn't feel her heart was racing. Her doctor instructed her to drink Gatorade and Pedialyte and she is still tired after doing all of that. Her doctor said she should have the shot, even though her blood heartrate went up 40. Her oxygen level is usually at 98 although she does have asthma, and her level was at 90. It was lower, under 98. She explains she had an EKG done at the doctors.She stated she was extremely dizzy in the beginning when she did get up and take a shower. Every day, her husband helped her get in the shower and take a shower. She received her first EKG when she went to the doctor on Tuesday 09Feb2021. The only thing wrong was her heart rate was 120. Her heart rate is usually high anyway usually 80 and sometimes 90. Thee has only been one time in the last 25 years, her heart rate went to 126. On 15Feb2021 EKG which showed HR as 106, oxygen was 96. The patient did not received prior vaccinations within 4 weeks. The outcome of the events dizziness was recovering, outcome of the event joints hurts was not recovered and outcome of the events were unknown
73 2021-03-30 palpitations roof of mouth felt numb; heart raced, then felt palpitations; strong headache; face flushed; exhaust... Read more
roof of mouth felt numb; heart raced, then felt palpitations; strong headache; face flushed; exhaustion for 36 hours; This is a spontaneous report from a contactable consumer (patient reported herself). A 73-year-old non-pregnant female patient received BNT162B2 (COVID 19, Formulation: Solution for injection, Lot number: EL9269) via an unspecified route of administration on 06Feb2021 11:00 AM at single dose for Covid-19 immunization. The patient's medical history included coronary artery disease (CAD), arthritis and known allergies/allergies. Concomitant medications were not reported. Other medications in two weeks: Yes. Facility type vaccine: facility. On 06Feb2021 11:00 AM, the patient experienced roof of mouth felt numb, heart raced, then felt palpitations, strong headache across eyes and forehead, face flushed and exhaustion for 36 hours. Covid was not tested prior or post vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date.
73 2021-04-01 cerebral haemorrhage Patient presented to the ER with a severe headache on 3/30. CT found subdural hematoma as well as i... Read more
Patient presented to the ER with a severe headache on 3/30. CT found subdural hematoma as well as intra-axial hemorrhage in the left axial lobe. The patient was life flighted from our facility.
73 2021-04-02 pulmonary embolism Pt. presented to ED on 5 Mar, day after vaccine with SOB and CT showed PE. Discharged from hospital... Read more
Pt. presented to ED on 5 Mar, day after vaccine with SOB and CT showed PE. Discharged from hospital on 6 March
73 2021-04-02 blood clot Two blood clots in my right calf that travelled up to my lungs; Shortness of breath; Pain in my righ... Read more
Two blood clots in my right calf that travelled up to my lungs; Shortness of breath; Pain in my right calf; Had difficulty just walking; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in left arm on 12Feb2021 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included heart (as reported) and known allergies to penicillin. There concomitant medications were not reported. On 15Feb2021 18:30 the patient experienced two blood clots in my right calf that travelled up to my lungs, shortness of breath, pain in my right calf, had difficulty just walking. It was reported that two nights after receiving the vaccine, she suffered shortness of breath and pain in her right calf. She tried to relax the next day, but had difficulty just walking. She went to a walk in medical facility. They sent her to the ER. After testing they found that she had two blood clots in her right calf that travelled up to my lungs. The event two blood clots in my right calf that travelled up to my lungs was considered as serious (hospitalization) and other event were considered as serious (hospitalization). The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included blood test on 15Feb2021 with showed two blood clots in my right calf that travelled up to my lungs and sars-cov-2 test with negative results on Feb2021.Therapeutic measures were taken as a result of two blood clots in my right calf that travelled up to my lungs, shortness of breath, pain in my right calf and had difficulty just walking. AE treatment included blood thinner. The outcome of the events was recovering. No other vaccine was given to patient in four weeks and two weeks. No Covid prior vaccination. If Covid tested post vaccination: Yes. Patient was covid tested post vaccination in Feb2021 with negative results. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Facility type vaccine was Public Health Clinic facility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
73 2021-04-05 cerebrovascular accident One week following the first dose of Pfizer, my Mom was not able to say her words on the morning of ... Read more
One week following the first dose of Pfizer, my Mom was not able to say her words on the morning of 3/22/2021 and was admitted to Hospital with the admitting diagnosis of a cerebral vascular accident. My mother was treated with TPA and spent 3 nights hospitalized in the ICU for a stroke. An MRI confirmed she had a left frontal lobe CVA. She was discharged to home on 3/25/2021.
73 2021-04-06 chest discomfort Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vo... Read more
Neuropathy; Shortness of breath; chest tightness; ringing in ears; fatigue; brain fog; dizziness; vomiting; vision changes; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:00 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, glaucoma, Manages cholesterol, controlled high BP and iodine contrast. The patient's concomitant medications were not reported. The patient experienced neuropathy, shortness of breath, chest tightness , ringing in ears, fatigue, brain fog, dizziness, vomiting and vision changes on 10Mar2021 03:00. The patient was hospitalized for all of the events for 2 days on an unspecified date. The patient underwent lab tests and procedures which included Nasal Swab: negative on 13Mar2021. The patient was not pregnant. Outcome of the events was not recovered.
73 2021-04-07 cerebrovascular accident, pulmonary embolism Stroke, pulmonary embolism
73 2021-04-09 ischemic chest pain pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoul... Read more
pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoulder; pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm; tooth ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6198, via an unspecified route of administration administered in right arm (shoulder) on 03Mar2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure abnormal, thyroid problems, fall (fell a couple of years ago), and trouble with her shoulder (prior to getting the vaccine). She reported that she did have some trouble with her shoulder prior to getting the vaccine. She fell a couple of years ago and the doctor's x-rayed it and thought it was pulling away from the bone. They didn't have to do surgery. She was completely over that and it had resolved before getting the vaccine. Patient has no additional vaccines administered on same date of the Pfizer suspect. Patient has no prior vaccinations within 4 weeks. Concomitant medications included metformin hydrochloride, sitagliptin (JANUMET) taken for diabetes from an unspecified start date and ongoing (been taking it a long time over 20 years); glipizide taken for diabetes, start and stop date were not reported (been taking it a long time over 20 years); losartan taken for blood pressure from an unspecified start date and ongoing (been on it about 10 years, her blood pressure is in between and it doesn't bother her a lot, it is not really high or low); and thiamazole (METHIMAZOLE) taken for thyroid problem from an unspecified start date and ongoing (been on it about ten years). Patient was calling because she had her first Pfizer shot about three weeks ago. About three days after on 06Mar2021, she developed pain in the right shoulder where she got the shot. It has been bothering her up until this time. She also had a pain over her heart area. The pain over her heart area occurred when she was breathing it. That has gone away. She had her second shot today and she was trying to explain to the doctor what happen to the right shoulder. He said the shot had to be in the other shoulder and he put it in the left shoulder in the bone. It hit the bone. She hollered because it hurt so bad. He said no one ever jumped like that before. She jumped because it hurt. She still has the pain in the right shoulder, but she doesn't feel anything in the left where she got it today. She clarified Pfizer shot as COVID19 vaccine. The pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm in Mar2021. She got first and second dose. She got the first dose of COVID19 vaccine on 03Mar2021. Pain in the right shoulder: it felt like her toothache has something to do with the pain in the shoulder. The toothache came on a little later (Mar2021) than the pain in the shoulder. The tooth ache is still ongoing, but it has improved. Pain over heart area: It started at the same time as with the pain in the right shoulder. The pain over the heart stopped about a week ago. She thinks she has recovered completely. She didn't have anything done for the heart pain. She got the second dose today, 25Mar2021, lot number: ER8733, Expiry date: unknown. The outcome of the events 'pain over her heart area and pain in the right shoulder travels down the right arm/it goes down the shoulder and down the arm' was recovered, event tooth ache was recovering, and events 'pain in the right shoulder where she got the shot (vaccination site pain) and pain in the right shoulder' was not recovered.
73 2021-04-12 blood clot Blood clot in left leg
73 2021-04-12 pulmonary embolism, oxygen saturation decreased Started experiencing wheezing and shortness of breath and reduction of oxygen level below 90 prior t... Read more
Started experiencing wheezing and shortness of breath and reduction of oxygen level below 90 prior to entering the ER on Sunday, March 21, 2021. Noticed particular shortness of breath Saturday before entering ER. Oxygen levels ran between 92 and as low as 87 that Saturday afternoon and Sunday morning. Also had severe stomach pain which was determined to be caused by gall bladder stone.
73 2021-04-12 ischaemic stroke ischemic stroke; vision changes; When looking up her vision was blurry & unclear; fuzzy; This is a s... Read more
ischemic stroke; vision changes; When looking up her vision was blurry & unclear; fuzzy; This is a spontaneous report from a contactable consumer (Patient) reporting on herself. A 73-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Lot no: ER0734) on unspecified route of administration on right arm (at the age of 73-year-old) as SINGLE DOSE on 28Mar2021 (between 14:30-15:00) for covid-19 immunization. There were no prior vaccinations within 4 weeks reported. The patient's relevant medical history included ischemic stroke, breast cancer, lymphedema in left arm and tendonitis in her right arm. The patient's concomitant medications were not reported. On 29Mar2021, the patient experienced vision changes. Upon follow-up (30Mar2021); When looking up her vision was blurry & unclear and the symptoms lasted for around one-two hours. On 29Mar2021, the patient looked at the clock on top (about 10' away), all the numbers were fuzzy. The patient said the numbers on the clock were 1 in height & she couldn't read them & her vision was very fuzzy. The fuzzy vision lasted approximately between 1-1/2 to 2 hours. It was reported that the patient vision recovered completely 1-1/2 to 2 hours afterwards. On an unknown date, the patient had ischemic stroke. The outcome of the events ischemic stroke, vision changes and vision blurred was unknown Follow up was needed, further information has been requested.
73 2021-04-12 blood glucose increased twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also ... Read more
twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived.
73 2021-04-13 pulmonary embolism, deep vein blood clot Had DVT (left leg) and PE, never had that before and 18mos prior had ultrasound of leg veins showing... Read more
Had DVT (left leg) and PE, never had that before and 18mos prior had ultrasound of leg veins showing no problems,
73 2021-04-13 cardio-respiratory arrest, loss of consciousness Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint... Read more
Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis.
73 2021-04-14 heart attack Eight days after receiving the second vaccine, I had a heart attack. The reason is unknown as I have... Read more
Eight days after receiving the second vaccine, I had a heart attack. The reason is unknown as I have none of the markers: high blood pressure, high cholesterol, obesity.
73 2021-04-15 deep vein blood clot Patients husband states patient had a DVT and went to hospital. Patient's husband was told for us ... Read more
Patients husband states patient had a DVT and went to hospital. Patient's husband was told for us to report this to VAERs due to her having recent covid vaccine. I do not have specific information regarding length of stay, etc. Pt has recovered.
73 2021-04-16 cerebrovascular accident Patient had a possible stroke, or possible head bleed from her fall yesterday. Documented s/s of CV... Read more
Patient had a possible stroke, or possible head bleed from her fall yesterday. Documented s/s of CVA prior to immunization. Pt has left-sided lower extremity functional limitations. left arm extremity weakness. left leg extremity weakness. Admitted to hospital from 1/14 - 1/18 Diagnosis CVA
73 2021-04-16 pulmonary embolism Pulmonary embolisms. Shortness of breath starting about 36 hours after injection. Treated with oxy... Read more
Pulmonary embolisms. Shortness of breath starting about 36 hours after injection. Treated with oxygen, Eliquis and Metropolol
73 2021-04-17 cerebrovascular accident Could understand words but could not answer back; Her symptoms came out as if she was having a strok... Read more
Could understand words but could not answer back; Her symptoms came out as if she was having a stroke.; Bad headache/migraine; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6207, expiry date: Jul2021), via an unspecified route of administration, administered in left arm on 19Mar2021 10:45 at single dose for COVID-19 immunization. The patient's medical history included diabetes from Jun2001 and ongoing. The patient's concomitant medication included metformin taken for diabetes from Jun2001 and ongoing. The patient previously received flu shot from immunization (she had the flu shot 20 years ago had bad reaction to). Facility where the most recent COVID-19 vaccine was administered was at the hospital. The vaccine was not administered at military facility. The patient received the vaccine on 19Mar2021 and she felt fine that Friday. On 20Mar2021 (Saturday), she started having a bad headache and took Aleve. She took Aleve 3 times 4 hours apart because she still had a bad headache. She started losing the ability to bring out words. She stated that her headache was gone. On 21Mar2021 (around 4 o clock), her husband was in the kitchen and asked her a question but could not understand her and asked again. She could not say the words but she could spell them. Her husband asked her another question, she tried to talk but she could not answer back. At that point her husband said they were going to the hospital. She was admitted for 3 days from 21Mar2021 to 23Mar2021. The doctor told her she was having a migraine because it had lasted for 2 days. She also spoke with her primary care provider, who looked it up and said this could be a side effect. She was told the migraine may take away the ability to talk. Her headache has been gone but continues to feel very tired (extremely tired since 19Mar2021). Her symptoms came out as if she was having a stroke on an unspecified date. The event 'could not understand words but could not answer back' required an emergency room visit.The patient underwent lab tests and procedures which included CAT scan, MRI, and contrast test, all with negative result on 22Mar2021. The outcome of the event 'could understand words but could not answer back' was recovered on 22Mar2021, the event 'bad headache/migraine' was recovered on 21Mar2021, not recovered for extremely tired, and unknown for the event 'stroke'.
73 2021-04-18 vaginal haemorrhage wiped herself there was blood on the toilet paper and "quite a bit in my pajamas".; cramps; distress... Read more
wiped herself there was blood on the toilet paper and "quite a bit in my pajamas".; cramps; distressed; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8730 and expiration date Jul2021) via unknown route on 01Apr2021at 16:00 at single dose for COVID-19 immunisation. Patient reported that she was allergic to bee stings so her doctor told her she should wait 30 minutes after getting the vaccine to observe for any reaction instead of the 15 minutes. The patient concomitant medications were Zydus, USP 75 mg Venlafaxine HCl (EFFEXOR XR). Patient was fine and left, when she got to her car she took 2 Tylenol and went to the grocery store and did some errands. 4 hours later, patient took 2 more Tylenol. Patient reported that this morning (02Apr2021) she got up from bed to go to the bathroom and noticed that when she wiped herself there was blood on the toilet paper and "quite a bit in my pajamas". Patient reported she was experiencing cramps. Patient believes she's having her period. Patient sounded distressed, reported that she hasn't had a period in years and now she is anxious and scared. Is really scared and wanted so seek medical advice. Unable to contact personal doctor, Declined ISI, cold transferred to PMI due to hold time. Will fax AE for side effects. Patient reported that yesterday she also started a new dose of her Effexor which was increased from 37mg to 75mg which she takes for anxiety and depression, she took the first increased dose yesterday evening and doesn't know if that is what caused this or the Covid shot. Her second dose is scheduled for 29Apr2021. Patient reported that she called her General Practitioner who was not in the office today and her GYN who hasn't yet called her back but she reports that the nurse instructed her to go to the walk in clinic for evaluation, but the caller reports she don't want to go because of the Covid. She spoke with someone before speaking to this agent saying they read her a bunch of information but it was not clear if she spoke with safety or customer service. Obtained the lot number for her first vaccine dose with exp. Patient stated 'I'm a nervous wreck" asking, if the symptom she was experiencing is from her Covid vaccine. Patient asked if her second shot supposed to be more than 21 days from the first. The case was reported as non-serious. Upon callback, she stated she has had a really bad day and spent all afternoon at the walk in clinic. She found out her symptoms were not related to the vaccine and said she could not talk anymore because she was driving. Callback made but caller said she could not talk and did not request a callback. The outcome of the events was unknown. Additional Information is requested.
73 2021-04-19 platelet count decreased, heart attack, haemoglobin decreased, loss of consciousness The patient is a 73yr old female with multiple comorbidities including but not limiting to ESRD on ... Read more
The patient is a 73yr old female with multiple comorbidities including but not limiting to ESRD on dialysis, DM, COPD on home oxygen, OSA not compliant with CPAP at home, pulmonary hypertension, tachy-brady syndrome s/p pacemaker in March 2021, with multiple admissions (?6) this year already, admitted with septic shock, NSTEMI on 4/13/2021. She underwent R foot debridement and amputation on 4/16/2021. ID team treated with Vanco/Cefepime. On 4/18 afternoon, she developed PEA and coded for about 25min. Since ROSC, she never regained consciousness. This morning, at the beginning of my shift at 7am, she's on bicarb drip, maxed Levophed 100, Epi 100 drips and full vent. However, she was getting paced and BP stayed in 40s. I discussed with ICU pharmacist and gave her stress dose Solu-cortef. Checked serum cortisol level, turned out to be appropriate later. Lactic acid 22 and bicarb was only 2 despite being on Bicarb drip. I called Shauna/daughter to inform her about guarded prognosis (imminent death) and asked to bring husband to come see her asap. Before family arrived, she developed another PEA and code blue was called. She was given Epi, bicarb pushes and CPR started immediately. Code blue was unsuccessful. At 8:13am, she was pronounced dead. I called daughter again to notify her of patient's death. Family arrived around 10am. I met both daughter and husband at bedside and offered emotional support. Chaplain was consulted. Disposition - critically ill patient with multi-organ failure, septic shock from R foot osteomyelitis, ESRD on dialysis, DM, COPD on home oxygen, OSA not compliant with CPAP at home, pulmonary hypertension, tachy-brady syndrome s/p pacemaker in March 2021 - Patient coded and did not survive
73 2021-04-24 nosebleed, blood clot Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mou... Read more
Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Face felt tight, first vaccine.; Mouth and nose dry, first vaccine.; Mouth and nose dry, first vaccine.; Sore arm, first vaccine.; This is a spontaneous report received from a contactable consumer(patient). A 73-year-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 73-years-old, via an unspecified route of administration, administered in Arm Left (in the back of the arm) on 20Jan2021 (maybe at 11:10 am) (Lot Number: EL3246; Expiration Date: Apr2021) as single dose for covid-19 immunisation. Medical history included ongoing Postural vertigo maybe 10 years ago for a day. No family medical history relevant to AE. The patient's concomitant medications were not reported. Patient got the Shingles vaccine years ago and the next day, she had a sore arm and tingles, up and down her arm. She didn't feel food for 7 days and felt achy. It was the first Shingles shot. No prior Vaccinations (within 4 weeks). The patient experienced blood and clots came out of nose and mouth on 21Jan2021 (the same time that she woke up) with outcome of recovered on 21Jan2021. She blew her nose and leaned over and noticed a drop of blood on the rug and grabbed a Kleenex. She blew her nose, easy, and all of a sudden blood and clots came out of her nose and mouth. It lasted for about 8 minutes. Sore arm on 20Jan2021 (started in the evening) with outcome of recovered on 21Jan2021. Face felt tight on 21Jan2021 (around 8:30 or 9:00 am) with outcome of recovered on 21Jan2021. Mouth and nose dry on 21Jan2021 (in the morning) with outcome of recovered on 21Jan2021.
73 2021-04-24 palpitations Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; ... Read more
Extreme fatigue; decreased energy; needed to sleep most of the day; difficulty maintaining balance; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 09Mar2021 12:00 (received at the age of 73-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included asthenia and known allergies to Sulfa drugs, NSAIDS. The patient was not pregnant. She did not have covid prior vaccination. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; and vitamins. The patient experienced extreme fatigue (fatigue) (disability, life threatening), decreased energy (asthenia) (disability, life threatening), needed to sleep most of the day (hypersomnia) (disability, life threatening), difficulty maintaining balance (balance disorder) (disability, life threatening), heart palpitations (palpitations) (disability, life threatening), all on 11Mar2021 04:00. These conditions started 2-3 days after the first vaccine (as reported). The adverse events resulted in Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient did not receive any treatment for the adverse events. Outcome of the events was recovered on an unspecified date in 2021. The patient was not tested for covid post vaccination.
73 2021-04-24 blood pressure increased, cerebrovascular accident had a stroke; instantly had a pounding headache; blood pressure was elevated; This is a spontaneous ... Read more
had a stroke; instantly had a pounding headache; blood pressure was elevated; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 25Mar2021, she received the first COVID-19 vaccine and instantly had a pounding headache. She went to her doctor who said her blood pressure was elevated and was going to do more testing. She and her sister went away thinking she just needed to relax but then had a stroke in the hotel that same day and was in the hospital for 3 days (until 28Mar2021). She has never had high blood pressure and no history of headaches. The doctor in the hospital thought that this could be related to the vaccine since she had no high blood pressure or headaches before. She asked the doctors if she should get the second one and they all said they don't know enough about the vaccine to give her guidance. Outcome of the events were unknown. Information about the Lot/batch number has been requested.
73 2021-04-27 deep vein blood clot This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration (injection), administered in the right arm on 12Feb2021 at 13:00 (batch/lot number: EL9267) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from 1991 and ongoing (diagnosed 30 years ago; doctor said that he didn't know if she has RA because she's taken all of those infusions and it may just be severe osteoarthritis), ongoing thyroid (disorder), thyroid was removed, knee replacement left leg from 2020 (she had knee replacement last year on her left knee), Achilles tendon tear - reported that she had to have surgery last to repair her right Achilles tendon as it tore, cholesterol (abnormal) from 1991 and ongoing (diagnosed with cholesterol problems 30 years ago), ongoing depression (diagnosed with depression a couple years ago), ongoing sleep problems (experienced sleep problems for a long time), blood pressure (abnormal) from 2013 and ongoing (diagnosed with blood pressure problems 8 years ago), physical therapy, lymphedema, and unable to recall exact dates. There was no family medical history. No prior vaccinations (within 4 weeks). Concomitant medications included amitriptyline taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); folic acid taken for arthritis from an unspecified start date and ongoing (she has been taking this medication for years and years); levothyroxine taken for thyroid, start and stop date were not reported (she has been taking this medication for years and years); chlordiazepoxide (LIBRIUM) taken for sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); losartan taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); meloxicam taken for arthritis from an unspecified start date and ongoing (began taking for 10 or 15 years after switching from celecoxib); metoprolol taken for blood pressure from an unspecified start date and ongoing (she has been taking this medication for years and years); omeprazole taken for stomach from an unspecified start date and ongoing (helps her stomach with all of the medications she has to take); pravastatin taken for cholesterol from an unspecified start date and ongoing (she has been taking this medication for years and years); desvenlafaxine succinate (PRISTIQ) taken for depression from an unspecified start date and ongoing (she started taking over a year ago, a year and a half or maybe two years ago); levothyroxine sodium (SYNTHROID) taken since thyroid was removed from an unspecified start date and ongoing (she has been taking since 15 years ago, for a long time); temazepam taken to help her sleep from an unspecified start date and ongoing (she has been taking this medication for years and years); cholecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date and ongoing (she has been taking this medication for years and years). The patient previously took BNT162B2 first dose on 21Jan2021 via injection in the right arm (lot number: EL3047 or EL3247; expiration date unknown) for COVID-19 immunization; and celecoxib (CELEBREX). The patient experienced extensive deep vein thrombosis on 06Apr2021; leg pain and feet swollen/ leg was like a balloon/ leg started to swell on 05Apr2021; throat hurts and tired on an unspecified date. The patient was calling about the Pfizer Covid-19 vaccine. She reported that she and her husband received both doses of the Pfizer Covid-19 vaccine. She received her first dose of the Covid-19 vaccine on 21Jan2021 and her second dose on 12Feb2021. She reported that she has had no complications before such as blood clots or problems with her blood or anything. She reported that on Monday, 05Apr2021, her leg started to swell. She reported that on the following day, 06Apr2021, her leg was so swollen that she couldn't put it down. She reported that she went to the emergency room on 06Apr2021 and was found to have an extremely extensive deep vein thrombosis. She reported that she was calling to complete a safety report. She stated that she doesn't want a deep vein thrombosis to happen to anyone else if her thrombus was from the Covid-19 vaccine. She reported that she and her husband thought they were so lucky as they had no side effects whatsoever following the Covid-19 vaccine doses. She reported that she was not saying that the deep vein thrombosis was from the Covid-19 vaccine but she has never had any blood or clotting problems in her life. Throat hurts: She reported that she thinks that when she was intubated, that whoever intubated her caught her tongue and cut it. She reported that she and her son and husband had been seeing news stories about the (Company name) vaccine. She reported that she has friends that were waiting for the (Company name) vaccine. She reported that her son wanted to send a text message so that others could be aware of the problems they might have. Leg pain: She reported that she went to the dentist on 05Apr2021 and was fine. She reported that when she got home from the dentist, her husband asked if she wanted to the take dog for walk. She reported that she put a leash on her dog and walked to the end of her driveway and said to her husband that she couldn't walk because her leg hurt so much. She reported that she had 2 surgeries last year, a knee replacement in her left leg and an Achilles tendon repair in her right leg. She reported that when she was released from physical therapy that the therapist told the caller that she might have lymphedema. She reported that the physical therapist directed her to go to a clinic that had no doctor where the clinic staff wanted her to buy a (dollar)10,000 piece of equipment to pump up her legs in the morning and at night. She reported that she came home from the clinic and called the podiatrist that repaired her Achilles tendon. She reported that she went to see the podiatrist that day and that the podiatrist ordered an ultrasound. She reported that a vascular surgeon called her regarding the ultrasound and stated that there was nothing wrong with the veins in her legs. She reported that the surgeon stated that they could tell there was nothing wrong with the her because her feet weren't swollen and instructed her to follow up in 9 months. She reported that on 05Apr2021, she went back into her house after experiencing the leg pain. She reported that her feet were not swollen and she was not that concerned. She reported that she thought maybe she was just tired and laid down. She reported that when she woke up the next morning, 06Apr2021, that her feet were like balloons. She reported that her son called a friend of his who was an orthopod. She reported that her son's friend instructed her son to take her to the emergency room, recommending that they bypass a certain hospital. She reported that she went to the emergency room on 06Apr2021. She reported that the emergency room staff did an ultrasound as soon as the caller arrived. She reported that the emergency room staff called the vascular surgeon. She reported that the vascular surgeon stated that if he had been in the caller's hospital room 5 minutes earlier that the would have done the surgery then, but that he had to lay her on her stomach to perform the surgery and she had eaten some cookies and drank diet soda. She reported that on the following day, 07Apr2021, the vascular surgeon put a scope in her vein and pulled out the clot. She reported that the physician was extremely concerned because the clots were very extensive. Leg pain: She reported that the leg pain was still ongoing. She reported that it hurts when she walks. She reported that she doesn't know if the leg pain has gotten worse. She reported that her leg pain on 06Apr2021 was excruciating and off the charts. Feet swollen: She reported that the swelling in her feet has maybe gotten slightly better. She reported that her feet were wrapped tightly with ace bandages. Leg swollen like a balloon: She reported that her leg was still swollen but it's gotten better, maybe about 90%. Extensive deep vein thrombosis: She reported that the deep vein thrombosis was removed on 07Apr2021 from her left leg. She reported that she was at end of her life and she had trips planned. She reported that she had a trip planned recently to go to Las Vegas with her daughter. She reported that her daughter was not able to take the trip, and stated she didn't know what would have happened if she had experienced the blood clot while in Las Vegas. She reported that she received both doses of the Covid-19 vaccine in her right arm, as she was in the car and her husband was driving. First dose: Date: 21Jan2021; Lot Number: She reported the lot number as EL3047, then stated that the handwriting was hard to read and that the lot number was either EL3247 or EL3047. She stated when reporting on her history that she has no concept of time and was unable to recall exact dates. She reported that while in the emergency room and during admission, the hospital staff did labs, but she has no idea what the results were. Vaccination facility type was drive through clinic at (clinic name). Vaccine administered at military facility: No. The adverse events leg pain, swelling in feet and leg, extensive deep vein thrombosis required a visit to the emergency room. Did not require a visit to the physician's office. The patient was hospitalized for 6 days for extensive deep vein thrombosis from 06Apr2021 to 12Apr2021. The patient underwent lab tests and procedures which included CT scan of chest: normal on an unspecified date, ultrasound: there was nothing wrong with the veins in her legs on an unspecified date, ultrasound: unknown results on an unspecified date. The outcome was not recovered for the event leg pain; recovering for the event feet swollen/ leg was like a balloon/ leg started to swell; and unknown for the rest of the events.; Sender's Comments: Reported events are assessed as intercurrent medical conditions probably associated to patients underlying conditions and are therefore unlikely related to BNT162B2.
73 2021-04-28 hypotension didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; ... Read more
didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; blood pressure 82/50; skin tenting; dizziness/orthostatic dizziness/dizzy; Nausea vomiting; Nausea vomiting; chills and cold sweats; chills and cold sweats/all sweaty, cold; felt blah; sore arm after 2nd dose; This is a spontaneous report from a contactable nurse reporting for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received BNT162B2 on 16Mar2021 (at the age of 73-years-old) for COVID-19 immunisation and experienced Sore arm and feeling blah. Clinical course was as follows: She spent 50 years in neurology and neuroscience, she was a crazy RN that did neurology right out of school, she was recommended for that specialty. She is not sure if she had a reaction to the vaccine or if it is just her. Her 2nd dose was last Wednesday, 07Apr2021. She had a sore arm and felt blah. Just like after the 1st shot. On Saturday night (10Apr2021) at 0200, she was awakened with chills, cold sweat, dizziness, nausea and vomiting. She was sick as a dog for 2 days and didn't eat or drink much of anything. She went to the doctor who sent her to an infusion center. She is down to 5' 2" and weighed too much. She has not been able to lose weight for a couple years. She gained 40 pounds when she turned 50 years old. After the shot, she had a sore arm and felt blah like she did after the first dose, but she thought everyone felt that way. She missed a day of gym class because of her really sore arm. This got better like after a flu shot, it was nothing. This time she had a really sore arm and felt blah after the shot but then on Saturday morning this whole thing started happening. She woke up very restless, was all sweaty, cold, dizzy and was too miserable to try and take her blood pressure. Her blood pressure tends to run low. Her symptoms of the sore arm resolved at 06:00 Saturday (08Apr2021). She had nausea and vomiting and couldn't eat or drink. That lasted through Monday morning. She had some back pain with this, but she has back pain normally as she is a little old lady. She had a scheduled Oncology appointment Monday, as did her husband. She experienced orthostatic dizziness. She woke up plain dizzy. Her doctor gave her a liter of fluids and it helped her. This was something that needed to be addressed. It was serious. It was all serious. She had nothing left to vomit. She is an old lady with Breast Cancer. Her creatinine level of 1.10 which dropped her GFR of 52, she calculated the GFR using a computer program. This is what lead to the doctor giving her a liter of fluid. She had an appointment scheduled and her doctor sent her to the infusion centers for a liter of D5NS. She was sent home afterwards and encouraged to drink fluids. She also had a CBC and chemistry panel with her blood work. She was worried because her skin was tenting badly, and she couldn't keep anything down. She was probably dehydrated. Her blood pressure at the doctor's office was 82/50. She didn't care that her skin was tenting. She has been drinking a lot of fluids as advised after her liter of fluids at the infusion center. She is interested in researching the MRNA process because it is used it in other things. The way the vaccine was developed, it should have dissipated after 48 hours. She likes to research everything. She and her husband experienced a year from Hell starting in August of last year. All events are considered serious. The patient underwent lab tests and procedures which included blood creatinine: 1.10 and blood pressure measurement: 82/50 on 12Apr2021, blood test, full blood count and investigation with unknown results and glomerular filtration rate: 52 on an unspecified date. The outcome of the events chills and cold sweat was recovered on 12Apr2021, skin tenting and orthostatic dizziness was recovered on 13Apr2021, vomiting and nausea was recovered on 14Apr2021, pain in arm was recovered on 10Apr2021, feeling abnormal was recovered on an unspecified date, while of the rest was unknown.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
73 2021-05-02 cardiac arrest This 73 year old black female received the Covid shot on 2/27/21 and went to the ED on 4/29/... Read more
This 73 year old black female received the Covid shot on 2/27/21 and went to the ED on 4/29/21 and was admitted on 4/29/21 with respiratory distress, cardiac arrest and other symptoms and died on 5/1/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
73 2021-05-02 cardiac arrest This 73 year old female received the Covid shot on 2/27/21 and went to the ED on 4/29/21 ... Read more
This 73 year old female received the Covid shot on 2/27/21 and went to the ED on 4/29/21 and was admitted on 4/29/21 with respiratory distress, cardiac arrest and other symptoms and died on 5/1/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
73 2021-05-04 palpitations one localized rash described as red with white lump; heart palpitations; Left breast hurt; Red rash;... Read more
one localized rash described as red with white lump; heart palpitations; Left breast hurt; Red rash; tingling of the left breast; Foggy different feeling; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received first dose of BNT162B2 (Pfizer COVID19, Solution for injection, Lot number EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at 15:00 for Covid-19 immunisation. The patients medical history included Breast cancer, thyroid cancer, blood pressure and palpitations. The patient had allergic to Z-pak. The concomitant medication includes Synthroid 150mcg 1 tablet by mouth once a day for thyroid cancer. Relevant Family medical history included Shingles shot, she took one a long time ago, like 10 years ago, it gave her ringing in the ear. She had no other vaccines on the same day on in the 4 weeks prior to the first dose. On 12Feb2021, the patient experienced Foggy different feeling, on 13Feb2021 at 16:00, tingling of the left breast, on 14Feb2021 experienced Left breast hurt, heart palpitations and localized rash described as red with white lumps. She had no ER visit. The outcome of the event foggy different feeling, left breast hurt, and white lumps was recovered, whereas of red rash and heart palpitations it was recovering and for tingling of the left breast it was recovered with sequelae. The patient underwent lab test which included blood work whose results were unknown and TSH with results 0.57. She wanted to know if those AEs are from the vaccine and if she is ok to get the second shot. She felt lightheaded for 20 minutes, in the left breast is where she had cancer and it was in situ in the duct, it had not spread for which she received 8 weeks of radiation. She went to bed and noticed that her breast was hurting in the night, but she was too tired to get up at that point, when woke up and took a shower she lifted the left breast and saw a massive, bigger than pancake, rash. It was on the bottom of the breast and it ran down to the stomach, it also had white lumps on it, this just frightened her. There was severe redness before, but that has started to fade, it was still dark brown right now, like she can see outline, but it was going away. Before when there was redness, she could press the spot and it would turn white, it would be red again. When read the instruction that came it says there could be a side effect of a rash, but it would be all over the body not localized. She does not know if the vaccine was responsible for it. Then just quickly she started having heart palpitations on Sunday, just a few, but on Monday it was like a 100 of them. She called doctor, at this point that she also has a history of thyroid cancer in 1982, they removed 2/3rds of her thyroid and since then she has been on Synthroid. When her thyroid was not working properly, she had a TSH done. She got lab work done just to see if it was the thyroid. The doctor said it could be from the shot. The Heart Palpitations were fading, she stopped taking Synthroid for 1 day and it went from 100 palpitations to 50, to like 6-7 now. The heart palpitations were going away and that was after stopping the Synthroid for 1 day. The Light headedness only lasted for 20 minutes but started 5 minutes after getting the shot. She clarified that it was not lightheadedness she means to say that she was a little foggy and had a different feeling. The tingling in the Left Breast began, it was for a couple hours, she thought it was different. Normally she doesn't have that. She has had 6 breast operations, so she has very little feeling in that breast normally. Her left breast began to hurt when she was sleeping, she was too tired to get up and look, she rolled over felt something was wrong. This was at 2-3AM on and it subsided when she took shower and patted all around, she dried it and kept an eye on it, the pain started to go away easily. She did notice that she started to feel a little bit of an itch, but that went away quickly too. She had the rash and lumps, it was during the shower she lifted the breast and saw it. She has a picture to provide. It is Not ongoing, it has started to fade, it is still dark reddish brown, but she can tell it was going away. The heart palpitations started late at 4 or 5 in the evening, she has not had that for years. She knows at one-point TSH was high, but they like to keep it low like this in which the 1/3 of thyroid stays dormant, this is intentional because if it gets too high.
73 2021-05-07 atrial fibrillation This is a spontaneous report from a contactable consumer (patient's daughter). A 73-year-old female ... Read more
This is a spontaneous report from a contactable consumer (patient's daughter). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) first dose on 28Feb2021 and second dose on 21Mar2021 (both at the age of 73-years-old) via unspecified routes of administration at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced atrial fibrillation after the first and second dose, both occurred two days after injection (on 02Mar2021 and 23Mar2021, respectively). The event lasted for approximately 12 hours with each episode. Outcome of the event was recovered in Mar2021. Information on the lot/batch number has been requested.
73 2021-05-10 pulmonary embolism I26.99 - Pulmonary embolism, bilateral (CMS/HCC)
73 2021-05-10 inflammation of the heart muscle Myocarditis
73 2021-05-10 platelet count decreased, low blood platelet count Patient reported feelings of malaise, SOB, and non-specific symptoms on 4/22. Patient sought medical... Read more
Patient reported feelings of malaise, SOB, and non-specific symptoms on 4/22. Patient sought medical care for symptoms on 05/08/2021. Patient was noted to have multiple large ecchymosis scattered over upper and lower extremities bilaterally; Plt. count came back at 7k, and patient was diagnosed with ITP (no prior history of ITP).
74 2021-01-06 chest discomfort Headache, dizziness, chest tightness, scratchy throat; No treatments provided in clinic. Patient mon... Read more
Headache, dizziness, chest tightness, scratchy throat; No treatments provided in clinic. Patient monitored until EMS arrived. Patient care handed over to EMS.
74 2021-01-14 chest pain sharp pain in chest
74 2021-01-18 blood pressure decreased At approximately 4pm on Jan 11, 2021, I began to have hard chills and fever that reached 104.9. I wa... Read more
At approximately 4pm on Jan 11, 2021, I began to have hard chills and fever that reached 104.9. I was admitted to ICU at the Hospital. My blood pressure dropped to dangerous levels. I was diagnosed with sepsis and the doctors determined it was caused by the vaccine.
74 2021-01-20 fainting, loss of consciousness Patient had a syncopal episode immediately after injection of the vaccine. Patient had brief LOC in ... Read more
Patient had a syncopal episode immediately after injection of the vaccine. Patient had brief LOC in her vehicle. Had a strong pulse and normal respirations. She opened her eyes and could follow commands approximately 2minutes later but had persistent altered mental status for 15-30min afterward. She was transported to the Emergency Department where she was monitored for approximately 1hr. Vital signs were notable only for baseline hypertension but otherwise normal pulse and oxygenation. She was back to baseline within about 30minutes and discharged from the ED after about 1hr.
74 2021-01-26 blood pressure decreased fever; severe chills/could not get warm; her breathing was deep; drop in blood pressure; mild swelli... Read more
fever; severe chills/could not get warm; her breathing was deep; drop in blood pressure; mild swelling/Swelling of Left Arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration in the left arm on 11Jan2021 10:00 at a single dose for COVID-19 vaccine (because she's 74 and high risk). Medical history included hypertension. Concomitant medication included irbesartan oral (by mouth) from an unspecified date (maybe 3 years ago) and ongoing at 300 mg once daily (150mg, 2 tablets once a day in the morning) for hypertension as blood pressure medication. The patient received the first dose of vaccine on Monday (11Jan2021) morning (AM) at 10 at the county (public) health department. She had no problem at all until yesterday Tuesday, she experienced mild swelling; the swelling happened in the upper left arm (swelling of left arm) which started on 12Jan2021, this was also the same side that she got her vaccine on, the left arm. On 13Jan2021 she woke up at 4AM [also reported as thirty (30) hours after the shot] in which she started to have severe chills (horrendous chills), could not get warm under the blanket for an hour and a half. It lasted a long time. Her severe chills did stop, she used an electric (heated) blanket. This morning on 13Jan2021 at 8:30, she woke up with the fever, which she was able to reduce with acetaminophen (did take two acetaminophen). Her fever was also gone. She was a little concerned because she thought her breathing was deep too on 13Jan2021. She did some relaxing breathing which helped. It lasted a long time. The patient also experienced a drop in blood pressure on 13Jan2021. Her blood pressure has been running the past few days at 133/80 on 11Jan2021. Today (13Jan2021), she took her blood pressure and it was at 93/50. It went to 87/56 after drinking some salty soup on 13Jan2021 (the bottom number in the blood pressure was going up a little, and the top number was going down a little). Her blood pressure has been normal 133/70 on Jan2021, but this morning it was 90/50 on 13Jan2021. Her blood pressure has been running normal the last couple of days like 133/90 on Jan2021. She was shocked it was lower. She knew they talk about dizziness and weakness, but she didn't experience that. She was concerned about that sudden drop in blood pressure. She did some research and started eating some salty soup and stuff (has been drinking salty soup). Her bottom number went up to 53 on Jan2021. She was concerned about that drop there. She was wondering if that was a side effect of the vaccine (result of the vaccine). She asked if drop in blood pressure was a concern. She had no positive test for Covid before the vaccine. She never had any tested, she's been pretty isolated. She had no antibody test. She has had no issues with vaccine in the past. Therapeutic measures were taken as a result of severe chills/could not get warm, fever, her breathing was deep, and drop in blood pressure. The outcome of swelling of left arm/mild swelling and drop in blood pressure was not recovered; of severe chills/could not get warm was recovered on 13Jan2021 05:30 and fever was recovered on 13Jan2021; and of her breathing was deep was recovering.
74 2021-01-27 palpitations Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday m... Read more
Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday morning
74 2021-01-28 hypertension 15 minutes after receiving injection, I began feeling very warm and it felt like I had a lump on the... Read more
15 minutes after receiving injection, I began feeling very warm and it felt like I had a lump on the right side of my throat. I was monitored in the ER, seen by the doctor and given 25 mg of Benadryl. My BP was high. I was discharged after approximately an hour and a half after incident. THESE WERE MILD SYMPTOMS. I was told to take Benadryl for the next 48 hours, which I did.
74 2021-01-28 fainting DIZZINESS, SYNCOPE
74 2021-01-31 palpitations, blood pressure increased Two hours after the vaccine I had heart palpitations, my lips were tingling and I felt fatigue and a... Read more
Two hours after the vaccine I had heart palpitations, my lips were tingling and I felt fatigue and appetite loss. This lasted about 30 minutes. 36 hours after vaccine I experienced headache, swollen tender left lymph node above collarbone and elevated BP 167/90. This improved after taking Advil.
74 2021-01-31 hypertension exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; so... Read more
exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; sore left eye; blood pressure very high and hard to control; shingles; This is a spontaneous report from a contactable consumer. A 74-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 08Jan2021 13:30 at single dose for covid-19 immunisation. Vaccine location was left arm. No other vaccine was received in four weeks. Medical history included hypertension, neuropathy peripheral, asthma/allergies, headache, allergy to medications, food. Concomitant medications included azelastine, fluticasone propionate (FLONASE), metoprolol, gabapentin, levothyroxine sodium (LEVOTHYROXINE). The patient experienced shingles on 08Jan2021 (immediately after she got the shot), exhausted on 09Jan2021 03:30, slept most of day/night on 09Jan2021 03:30, pain in scalp, pimples, bumps on 09Jan2021 03:30, sore left eye on 09Jan2021 03:30, blood pressure very high and hard to control on 09Jan2021 03:30. Patient was treated with Valacyclovir, lisinipril, metropolis, aquafor. The outcome of shingles was unknown. The outcome of exhausted, slept most of day/night, pain in scalp, pimples, bumps, sore left eye, blood pressure very high and hard to control was not recovered.
74 2021-02-01 troponin increased, chest pain Altered mental status; Chest pain; Elevated troponin; Generalized weakness
74 2021-02-02 blood pressure increased Flushing and sweating - signs of diaphoresis 10-15 minutes after the vaccine dose. FS 119 per patien... Read more
Flushing and sweating - signs of diaphoresis 10-15 minutes after the vaccine dose. FS 119 per patient. BP 154/85 (baseline, 120's/60's), pulse 64. Given juice, rested, felt better after 15 minutes.
74 2021-02-04 atrial fibrillation Atrial Fibrillation began 7 hours after vaccine administered, lasted for 3 hours and then returned t... Read more
Atrial Fibrillation began 7 hours after vaccine administered, lasted for 3 hours and then returned to normal rythm.
74 2021-02-04 chest discomfort Pfizer-BioNTech COVID-19 Vaccine EUA drive thru vaccination clinic - Patient with complex medical h... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA drive thru vaccination clinic - Patient with complex medical history including multiple allergies experienced reaction within minutes of receiving dose #1. Premedicated with benadryl and sublingual allergy med. Reaction include tingling and numbness with thickness of tongue, difficulty swallowing and chest tightness. She has NTG but has never had to use. 911 called and patient brought to ED. Seen and discharged after patient felt better.
74 2021-02-04 hypertension Within 15-minutes of vaccination, the patient reported feeling lightheaded and nauseous. Patient was... Read more
Within 15-minutes of vaccination, the patient reported feeling lightheaded and nauseous. Patient was found to hypertensive (170/88) compared to baseline hypotension. Patient was evaluated for 20-minutes and her vitals and mentation returned to normal. The patient refused transport and was able to ambulate to her daughter's car.
74 2021-02-06 hypertension 30 minutes after injection started noticing numbness and tingling in left arm. It also went to left ... Read more
30 minutes after injection started noticing numbness and tingling in left arm. It also went to left side of my face. Felt like Novocain after a dentist visit. Also had high blood pressure. 232/100
74 2021-02-07 heart rate increased At 3:30 am after receiving the vaccine the day before at about 11 am, woke up with chills, low-grade... Read more
At 3:30 am after receiving the vaccine the day before at about 11 am, woke up with chills, low-grade fever (99.4 when normal temperature is in low 97s). Also had a fairly bad headache, a fast heartbeat of up to 111, hips and legs ached, and felt a bit nauseated. At about 9 am took 1 extra-strenghth Tylenol, with little help. At 1 pm took 2nd Tylenol and all symptoms were pretty much gone by 3 pm in the afternoon.
74 2021-02-08 anaemia, fainting, ischemic chest pain My mom only had site soreness after her covid vaccine on 1/21 which resolved within a couple days. H... Read more
My mom only had site soreness after her covid vaccine on 1/21 which resolved within a couple days. However, she died in the early morning hours of 1/25, she was fine the day before, no sign of injury. We found her collapsed on the ground and although we tried cpr she was already dead. She had gone to the hospital on 12/28 for shortness of breath, angina and symptomatic anemia, her ekg was unchanged and blood work normal except for anemia. The cardiologist did not think a cardiac cath was needed. Her shortness of breath improved with a blood transfusion and a dose of lasix (no heart failure).
74 2021-02-08 blood pressure increased Received Pfizer vaccine on 2-3-2021, checked blood pressure on Saturday 2-6-2021, she noticed her bl... Read more
Received Pfizer vaccine on 2-3-2021, checked blood pressure on Saturday 2-6-2021, she noticed her blood pressure was a bit elevated. Later 2/8/2021 went to ER due to home systolic BP in 200s, no other symptoms reported. Discharged from ER same day, reports was told by hospital staff possibly from recent vaccine. Did not have labs or other testing while at ER she states. Today 2/9/2021 blood pressure improving 150s systolic, pending to restart her blood pressure medication.
74 2021-02-09 heart rate increased Heart beat is high/I am having my heart beat is fast and usually it's low, I just feel weird; Sore o... Read more
Heart beat is high/I am having my heart beat is fast and usually it's low, I just feel weird; Sore on the arm; This is a spontaneous report from a contactable consumer reporting for self. This 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included acid reflux, stomach relaxer, IBS (irritable bowel syndrome). Concomitant medications included hyoscyamine sulfate for stomach relaxer, omeprazole (PRILOSEC), Vitamin D2, omeprazole for acid reflux. On 23Jan2021, the patient experienced heart beat was high, she was having heart beat was fast and usually it's low, she just feel weird, and also experienced sore on the arm. No treatment received. Lab data included Height: 5ft 5 inches and weight: 140 pounds on unspecified date. The outcome of events was not recovered. Information about lot/batch number has been requested.
74 2021-02-10 fainting Pt. had left observation site after observed for 30 minutes. Pt. reported swollen eyelids, "thick" t... Read more
Pt. had left observation site after observed for 30 minutes. Pt. reported swollen eyelids, "thick" tongue, and tingling lips. Pt. triaged by EMT, and received 50 mg IM Benadryl. Pt. observed for 30 minutes. Upon getting up after observation, pt. had syncopal event. Pt. refused ED transport. Pt. observed for another 15 minutes, symptoms resolved. Pt. went home.
74 2021-02-11 chest discomfort angioedema, lip paresthesia, tongue swelling, dry eyes, chest tightness
74 2021-02-12 fast heart rate, blood pressure decreased Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccin... Read more
Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccine. Itching started that evening. Next day went to PCP who ordered 3 doses of prednisone 20mg and benadryl 25mg every 6 hours PRN. Day 2, rash/welts increased as well as itching. Evening of day 2, rash to legs progressed to purpura, temp of 102.7, chills and extreme pain to bilateral hips which prompted taking to ED and being admitted to progressive care unit.
74 2021-02-14 blood pressure increased After receiving the vaccine, she complained of an allergic reaction. The onsite EMS was requested. ... Read more
After receiving the vaccine, she complained of an allergic reaction. The onsite EMS was requested. Her vitials were BP 172/84 HR 76 O2 99% on room air. Patient refused additional evaluation and released home against medical advise
74 2021-02-16 atrial fibrillation Atrial fibrillation; This is a spontaneous report from a contactable consumer (reported for herself)... Read more
Atrial fibrillation; This is a spontaneous report from a contactable consumer (reported for herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318; expiry date: not known), via an unspecified route of administration in the left arm on 01Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included deep vein thrombosis (DVT) and allergies to sulfa drugs. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient previously took amoxicillin, clavulanate potassium (AUGMENTIN) and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced atrial fibrillation on 01Feb2021 17:45. No treatment received for this event. The outcome of the event was recovered on an unspecified date in Feb2021.
74 2021-02-16 loss of consciousness Passed out and fell to the floor before daylight; Passed out and fell to the floor before daylight; ... Read more
Passed out and fell to the floor before daylight; Passed out and fell to the floor before daylight; Dizziness; This is a spontaneous report from a contactable consumer (patient's spouse). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265) on 01Feb2021 at 13:15 at single dose intramuscular COVID-19 immunization. Relevant medical history included Alzheimer's disease diagnosed about 5-6 years ago, seizure (diagnosed 40 years ago) and ongoing high blood pressure. Concomitant medications were not reported. On 02Feb2021 patient passed out and fell before daylight morning, it may be around 06:00-07:00 (as reported). Patient's spouse informed that got up early and was already up when she called him to tell him she had fallen. She sleeps a lot anyway, so she was just put back to bed. Reporter didn't known exactly when she was up again. It was also informed that several of the medications that she took have side effects like dizziness (as reported). At the time of the reporting event outcome was unknown.
74 2021-02-17 heart rate abnormal Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kid... Read more
Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kidney failure and allergic reaction; Allergic Reaction; still wasn't feeling normal; Could not keep head up and was in bed; breathless; extreme fatigue; exhausted and weak; Heart was banging fiercely; Totally dehydrated; Urinating a great deal more; Chills, shakes and felt terrible; Chills, shakes and felt terrible; sicker every single day/sick/felt terrible; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on the left arm on 18Jan2021 14:30 at a single dose for prevention for COVID. Medical history included hip replacement on 04Jan2021 and fibromyalgia (When her children were younger, she was told she had Fibromyalgia). Family history includes diabetes (father late onset) and very rare cancer (mother). There were no concomitant medications. It was reported that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and got sick the next day (19Jan2021). She also mentioned that she got sicker every single day. Then after 8-9 days, she said she started to feel better, but still wasn't feeling normal. She said she had extreme fatigue, was breathless, and felt exhausted and weak on an unspecified date. She said she was supposed to receive the 2nd dose of the vaccine this Monday (unspecified date), but because of her side effects, she was told that she can come back to receive the 2nd dose after 6 weeks. She wants to know if this is acceptable. The patient reported that on 19Jan2021, she woke up in the middle of the night with chills, shakes, and felt terrible. She cancelled her plans for Tuesday (as reported). On Wednesday, she forced herself to get up and went out for lunch and came home. She could not keep her head up and went back to bed and that lasted several days. It got worse before it got better. She ended up being hospitalized for 4 days (25Jan2021 to 29Jan2021). It appeared to be she was in Kidney Failure and experienced allergic reaction on 25Jan2021 and her white blood cell count was elevated (unspecified date). She went to the ER and they kept her 6-8 hours and discharged her on a Friday and by Monday, she was admitted to the hospital. The first ER visit, she was there for 6-8 hours and they sent her home. They gave her IV fluids and took a lot of tests. The patient's first ER visit was on 22Jan2021, and was kept for 6-8 hours and released. She was given IV fluids and they did a lot of tests. She went to see her doctor and sent her to the emergency room. They took her blood, EKG and everything seemed ok. Creat was 1.0 and by Monday it was 1.6 and then on Friday it was 1.9 (unspecified dates). She was admitted to hospital on Monday and they gave her IV fluids and did kidney test and admitted her as soon as she could get a room. She never had a problem before with her kidneys. They did bacteria test and they were normal. The patient called her doctor on 24Jan2021, because she was nauseous, dizzy, and room was spinning and she felt worse. She went to his office on Monday morning and he put her right in the hospital (unspecified date). She got worse and now it is improved. Heart was banging fiercely on 22Jan2021 20:00. They took an Echocardiogram. She has never had a cardiac problem and could not find anything wrong with her heart. The patient started feeling a bit better. She was sick as can be through Sunday. By Tuesday (unspecified date), she was a little better and today is a little better. She is urinating a great deal more because of fluids, but later said it started the day after she got it. She had to get an aide to take care of her. The patient experienced totally dehydrated on 22Jan2021 14:00 and urinating a great deal more on 19Jan2021 03:00. Therapeutic measures were taken as a result of kidney failure, allergic reaction and white blood cell count was elevated. The outcome of the events sicker every single day/sick, chills, shakes and felt terrible was not recovered; event could not keep head up and was in bed recovered with sequel; events nausea, dizziness and room spinning, heart was banging fiercely, totally dehydrated, urinating a great deal more was recovering; while unknown for the rest of the events.
74 2021-02-17 excessive bleeding Noticed light spotting; This is a spontaneous report from a contactable consumer reporting for herse... Read more
Noticed light spotting; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number E19769 and expiry date unknown) on 06Feb2021 15:30 at single dose via an unspecified route of administration into her left arm for COVID-19 immunization. There were relevant medical history and no concomitant medications. The patient had not had COVID prior to the vaccination, COVID not tested post the vaccination. The patient was not pregnant. She noticed light spotting on 07Feb2021 at 21:45. No seriousness criterion provided. No treatment was received. The outcome of event was unknown.
74 2021-02-18 blood pressure increased Adverse effects began immediately on 02/16/2021 after the 1st Pfizer Covid shot at 3.45p. They incl... Read more
Adverse effects began immediately on 02/16/2021 after the 1st Pfizer Covid shot at 3.45p. They included flushing & face really hot & much higher than normal BP. My BP, usually low, 95/67 pulse 61 that morning rose precipitately to 142 in the parking lot via a nurse who tested me. It subsided to 125 within 30 mins. BUT the next morning, W the 17th, it again rose precipitately from 99/65 pulse 74 at 9am to 141/88 pulse dropped to 66, at 10a, it was 150/88 pulse was 73, at 10.30a it was 156/93 pulse 80 and I called the nurse. Again BP rose to 160/84. I tested my right arm where I rec.d the shot, it was still sore. I suggested going to Urgent Care, the nurse advised the ER. I went to ER & by then my BP lowered to 140 & within an hour I left. I notified my doctor bvia a voice mail to her PA and an email today. Im feeling fine today Feb. 19, 2021 & felt fine yesterday Thursday, Feb 18, 2021. With the unusually high BP I felt shaky. This high of a BP is something Ive never experienced before in my life. It was frightening. My only other near death experience was in 1970 at a Hospital getting a broken tooth repaired bc of a car accident. They gave me an injection of Demerol & I immediately went into shock, perhaps anaphylactic, was given Epinephrine I believe & survived the ordeal & he was able to repair the cracked tooth. I was advised to never have Demerol again. It is such a vivid memory I checked with my doctor prior as I was very concerned about the PEG in the Demerol injection & also in the Pfizer vaccine. She advised that I was at a very low risk for adverse reactions from the Pfizer shot. I preferred Moderna after reading it had 1/2 of the Pfizer adverse reactions reported. I was not so lucky.
74 2021-02-18 blood pressure increased Attended vaccine clinic with friend. After receiving vaccine and moving to observation area, pt repo... Read more
Attended vaccine clinic with friend. After receiving vaccine and moving to observation area, pt reports noticing? her mouth feels numb and tingly?. Pt has history to surgery for non-cancerous tumor on skull that involved the nerves in the early 2000s resulting in facial asymmetry and some swelling and redness around her left nares. Face inspected and her friend reports that it looks normal for her. Facial asymmetry continues but when assessing face, her friend reports the asymmetry is her norm. VSS BP 166/108, HR-68, Resp 14. She reports that BP goes up. She has no side effects with the first dose but reports feeling ?extremely anxious about coming to get this vaccine?. Arm and leg strength are equal bilaterally. Pt drank water and says she is feeling better by 2:42. She reports no longer feeling tingly but her lips are still numb> 2:52 symptoms resolved with no additional symptoms reported. 3:01 no further s/s reported. Reviewed s/s of reactions vs side effects. Agrees to notify PCP of response after vaccine and also agrees to call 911 with any s/s reaction upon leaving Facility.
74 2021-02-21 heart rate decreased Lip swelling, low heart rate, dizziness. Took patient to the ER for evaluation.
74 2021-02-22 chest pain Patient finished her 15 minutes wait and made her way the vehicle. Shortly after reaching the vehic... Read more
Patient finished her 15 minutes wait and made her way the vehicle. Shortly after reaching the vehicle was feeling short of breath. Rapid response team from hospital came out and transported her to the emergency room. Most current nursing note as of 20 minutes ago, "pt complains of chest pains sob difficulty swallowing and weakness. pt is AA+Ox 4 and has a room air sat of 98% rr of 22, hr of 71."
74 2021-02-23 palpitations 12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sle... Read more
12 hours after injection, I got nauseated, flushed, low grade temperature, racing heart, did not sleep entire night.
74 2021-02-23 blood pressure decreased Extreme drop in blood pressure: Vaccine at 3:30 PM first drop @ 5:15 Pm to 84/51 HR 93; @ 5:50 PM 8... Read more
Extreme drop in blood pressure: Vaccine at 3:30 PM first drop @ 5:15 Pm to 84/51 HR 93; @ 5:50 PM 80/41 HR95; 7:00 PM 128/60 HR 50; 3:40 AM 85/46 HR 58-Irregular. This continued -the up 7 down till this writing (2/24 @ 9:30 AM). Also body aches, chills, barely able to move. No headache this time. Almost forgot - vomiting from 8:00 PM (2/23) till midnight (approx). I have vision difficulty from time of vaccination till now. I think that is all. General not feel goods!
74 2021-02-23 hypotension Kidney infection; Wheezing in chest; her blood pressure is so low right now they can't even transfer... Read more
Kidney infection; Wheezing in chest; her blood pressure is so low right now they can't even transfer her to the hospital that can actually perform the surgery she needs; became very weak and didn't tell anyone/too weak to get up; mother was swollen from head to toe with edema; mother was swollen from head to toe with edema; fell using her walker on Wednesday/fell again; Laceration of face; having issues with her kidneys and has progressively declined since; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history using her walker. Concomitant medications were not reported. The consumer reported that her mother had the COVID-19 Vaccine on 21Jan2021. She was now hospitalized and was due to have the second vaccine on 11Feb2021 and stated that her mother was completely unstable for the second vaccine. After receiving the COVID-19 vaccine, medically, she seemed fine. Then, she progressively has gotten worse. First EMS was called. This was about less than a week later after receiving the vaccine. Then, she was admitted into the hospital with a kidney infection and she has progressively declined. She has no idea if it was related to the COVID-19 vaccine or not. She initially called regarding the second COVID-19 vaccine. She didn't know what would happen if her mother didn't show up for her second vaccine. She didn't know if she would get on the "never going to get the vaccine" list or what as her mother was just so unstable. On an unspecified date, her blood pressure was so low right now they can't even transfer her to the hospital that can perform the surgery she needs. The reporter stated that she has no idea if this was COVID related or what. She began having problems less than a week later after receiving the COVID-19 vaccine, she mentioned Wednesday. On 27Jan2021, her mother began having issues with her kidneys and has progressively declined since. Consumer stated her mother was swollen from head to toe with edema on an unspecified date and that was how this all kind of started. Her mother became very weak and didn't tell anyone. She fell using her walker on Wednesday and the EMS was called. Her mother told the EMS she wasn't hurt but was just too weak to get up and EMS got her up. Her primary care doctor sent her for an x-ray, and she had some wheezing in her chest. She was given an antibiotic for that. The patient fell again, and the EMS was called and had some face lacerations and stuff, so she was taken to the hospital. Consumer confirmed her mother was admitted into the hospital and was first diagnosed with a kidney infection and it has progressively gotten worse. Outcome of event kidney infection was not recovered; and outcome of the rest of events was unknown. Information on lot/Batch number has been requested.
74 2021-02-23 atrial fibrillation Patient presented to hospital with increasing SOB, dyspnea on 2/22/21 (vaccine dose on 2/9/21). Pat... Read more
Patient presented to hospital with increasing SOB, dyspnea on 2/22/21 (vaccine dose on 2/9/21). Patient is still currently admitted to monitor respiratory status and has been diagnosed with unilateral diaphragmatic paralysis.
74 2021-02-24 heart flutter 0843a patient c/o chest flutter, no SOB or any other symptoms. BP 130/78 oxygen 97% HR 100, seen by ... Read more
0843a patient c/o chest flutter, no SOB or any other symptoms. BP 130/78 oxygen 97% HR 100, seen by EMS and at pt's side. No new interventions provided. Monitored patient an additional 15 minutes . At 0905, patient feeling slightly better BP 134/74, HR 101 and down to 94, oxygen level 93 to 94%, . Patient feels ok to go home, released by EMS and assisted to son's car.
74 2021-02-24 chest discomfort Around 5 minutes after 2nd vaccination, patient states she is dizzy, shaky and feeling like she is g... Read more
Around 5 minutes after 2nd vaccination, patient states she is dizzy, shaky and feeling like she is going to pass out. Provided water, cold towel and being monitored by nurse. Denies any shortness of breath or difficulty breathing. States symptoms persist for the next 30 minutes while refusing to go to ED. Daughter arrives and instructs patient to ED. Escorted to ED with the patient still complaining of persistent dizziness, lightheadedness, and brief chest tightness which subsided within 5 minutes.
74 2021-02-24 chest discomfort Heaviness across the chest and harder to get deep breath when needed. Lasted throughout the evening... Read more
Heaviness across the chest and harder to get deep breath when needed. Lasted throughout the evening and night but was OK the next morning.
74 2021-02-24 hypertension flushed in face, high blood pressure,
74 2021-02-25 blood glucose increased blood sugar level is over 400; This is a spontaneous report from a contactable consumer who reported... Read more
blood sugar level is over 400; This is a spontaneous report from a contactable consumer who reported for herself. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN5318) on 09Feb2021 at 15:00 (at 74 years) at single dose in left arm for covid-19 immunisation. Medical history included type 2 diabetes mellitus, high blood pressure. Concomitant medication included metformin and diphenhydramine hydrochloride (LURISPAN). Patient was not pregnant.The patient previously took epinephrine and had drug allergy. The patient blood sugar level was over 400 on 10Feb2021. No treatment given for the event. The final outcome of the event was not recovered.
74 2021-02-26 nosebleed 15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drain... Read more
15 minutes after injection, clear nasal drainage. 30 minutes after injection, more clear nasal drainage and slightly bloody nostril. Tired in evening of injection, slight soreness right are. Next day, up performing usual home kitchen activities, reading, making and drinking coffee. Then SUDDENLY at exactly 23 hours after the injection, began experiencing extreme difficulty breathing, unable to speak in full sentences. Called Primary Providers Office and was directed to go to an emergency room ASAP.
74 2021-02-26 hypertension, blood pressure fluctuation Extreme high blood pressure 201/100 , goes from extreme to normal in an hour continuously.
74 2021-02-26 palpitations PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS ... Read more
PALPATATIONS, SWEATY HANDS, BODY TINGLING. PALPATATIONS RESOLVED PATIENT STILL FELT COLD AND CHILLS STARTED. SHE WAS SENT TO THE ED FOR EVAULATION.
74 2021-02-28 cardiac arrest Pt presented to hospital via ambulance with cardiac arrest after a CC of SOB. Pts sister who spoke ... Read more
Pt presented to hospital via ambulance with cardiac arrest after a CC of SOB. Pts sister who spoke with her two days ago stated she was in normal state of health and just got her 2nd dose of the covid vaccine. Unknown which manufacturer.
74 2021-02-28 chest pain Reports x 1 week s/p vaccine on 2/20/2021. C/O sharp left sided chest pain, cough, wheezing and gen... Read more
Reports x 1 week s/p vaccine on 2/20/2021. C/O sharp left sided chest pain, cough, wheezing and generalized weakness
74 2021-02-28 palpitations, chest discomfort, heart rate increased rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitatio... Read more
rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitations; quivering in chest and palpitations; lightheadedness; tired; anxious; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on 22Jan2021 at 15:30 at a single dose on left arm for COVID-19 immunisation. Medical history included triglycerides high, obesity, blood clotting issues, thyroid disorder and blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, rosuvastatin calcium, aspirin (acetylsalicylic acid) and vitamin D3. The patient experienced rapid heartbeat, headache, quivering in chest and palpitations, lightheadedness, pain in her arm at the injection site, tired on 23Jan2021 and anxious on 22Jan2021. The patient stated that on Saturday (23Jan2021), she noticed pain in her arm at the injection site, a headache, and feeling of like she was quivering in her chest. She was also experiencing palpitations, lightheadedness, and periods of rapid heartbeat. On Monday, the symptoms were a little less but yesterday and today she has had a lot of palpitations, quivery feelings in her chest and rapid strong heart beats. On Saturday, she took an aspirin for headache. On Sunday, she had just a mild headache and by Monday (25Jan2021) it was gone. She wanted to know if these are normal reactions and if she should call the doctor, or what she should do about them. The patient underwent lab tests and procedures which included blood triglycerides: high and body mass index: high on Jan2021; heart rate: rapid on 23Jan2021. Therapeutic measures were taken as a result of headache. The outcome of the events pain in her arm at the injection site and headache was recovered on 25Jan2021, while of the rest was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116966 same reporter/drug, similar events, different patient
74 2021-03-01 hypertension Blood pressure feels really high; This is a spontaneous report from a contactable consumer (patient)... Read more
Blood pressure feels really high; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 16Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 virus in the past year (2020) from which her husband died last year (2020), receiving occupation therapy (OT) at home, and stroke (in the past). The patient's concomitant medications were not reported. The patient received her first Pfizer COVID-19 vaccine dose on 16Jan2021 and is scheduled to receive her next COVID-19 vaccine booster on 06Feb2021. The last time the patient had her COVID-19 virus antibody blood work was on 11Jan2021, and her COVID-19 virus antibodies were down to 1.9 from 8 (on an unspecified date). The patient's COVID-19 virus antibodies have been progressively going down since she was first being tested for them. The patient received a call today that her occupational therapist tested positive for the COVID-19 virus. Both her occupational therapist and she were wearing masks when working together. The patient received the call today because she was exposed to the occupational therapist. The patient asked if she can still take the COVID-19 vaccine booster that she is scheduled for on Saturday (06Feb2021). The patient really wanted to get the COVID-19 vaccine booster on 06Feb2021. The patient was going to be speaking with a trained healthcare professional when she is transferred to Pfizer medical information. Anyone the patient has spoken to about getting her second COVID-19 vaccine has not been willing to answer her questions. The patient's blood pressure feels really high now (02Feb2021), and she has had a stroke in the past. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
74 2021-03-01 blood glucose increased, platelet count decreased With first shot, mild itching all over. One Day. With second shot on 2/16- itching, took Benedyl an... Read more
With first shot, mild itching all over. One Day. With second shot on 2/16- itching, took Benedyl and tylenol. On 21st sore all over, knees, back, shoulders, difficulty rising from seated position. It was as if all my joints were inflamed. Had strange bruise of left thigh, Dificulty walking. Took warm bath, muscle rub, ibuprofin, Pain continued on 10.,muscle spasms. When to ungent Care 2/27. Test Netrophils 61.7,lymphs 30.0, monos 6.0, eos,2.1 baso 0.2, AnC 2.99;Lymphs 1.45, monos 0.29, eos auto 0.10,BASO,001, WBC 4.8, RBC 4.70. HGB 12.7 HCT 39.8, MCV 84.7,MCHC 31.9.RDW<BLOOOD, 14.0,PLT'S AUTO,NA 141, K 4.1,CL 103, CO2 29. CREAT 0.86, GFR 77, BUN 15 , GLUC 112, ESR 23
74 2021-03-01 palpitations, blood pressure increased about 4 hours after the shot I realized my heart was racing and my throat felt ticklish. I also noti... Read more
about 4 hours after the shot I realized my heart was racing and my throat felt ticklish. I also noticed that the insides of both forearms were a bluish mottled color. Then I started uncontrollable shivering that lasted about 90 minutes. We went to the ER within 15 minutes of symptoms starting.
74 2021-03-01 palpitations, atrial fibrillation sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass ou... Read more
sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization. Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00. The patient outcome of the events was recovering.
74 2021-03-02 inflammation of the pericardium Acute pericarditis; Atrial arrhythmia; This is a spontaneous report from a contactable consumer (pat... Read more
Acute pericarditis; Atrial arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on left arm, on 17Feb2021 10:45 (at the age of 74-year-old, not pregnant), at single dose, for Covid 19 (COVID-19 immunization). Medical history included allergies to alpha antibiotics. No COVID prior vaccination. Concomitant medications included atorvastatin, and bupropion. No other vaccine in four weeks. The patient previously took codeine and experienced allergies. The patient experienced acute pericarditis and atrial arrhythmia, both on 20Feb2021 15:00. Events resulted in emergency room/department or urgent care, and hospitalization (for 1 day). The patient underwent lab tests included COVID test (Nasal Swab/COVID 19 PCR) post vaccination on 21Feb2021, result was negative. Therapeutic measures were taken as a result of events and included treatment with multiple. The outcome of the events was recovering.
74 2021-03-02 blood glucose increased Complete Cranial Nerve 3 Palsy, left side Symptoms: Diplopia, Ptosis
74 2021-03-02 pallor Tingly, nausea; pallor
74 2021-03-02 chest pain, atrial fibrillation chest pains; fever over a 100°F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report... Read more
chest pains; fever over a 100°F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose on 25Jan2021 and experienced health issues in Jan2021 as AFib, diabetic, COPD, stomach issues, and reported to "have a lot of issues". The primary doctor thought it's better for her to get the dose than get COVID-19. Patient also reported that about 20 minutes after the first dose on 25Jan2021, patient had chest pains, from one side clear across the other side and took a Nitro, and patient had fever over a 100 degree F for 24 hours. The outcome of the events was unknown. Information on about lot/batch number has been requested.
74 2021-03-02 fibrin d dimer increased, chest discomfort fever, chills, HA, vomiting, diarrhea, chest tightness, SOB, nonproductive cough; received 1000 mg a... Read more
fever, chills, HA, vomiting, diarrhea, chest tightness, SOB, nonproductive cough; received 1000 mg acetaminophen, GI cocktail, liter ND, liter LR, zofran on discharged, mild tacyhpnea with accessory muscle usage (minimal); abdominal tenderness in epigastric area,
74 2021-03-02 chest pain my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not bre... Read more
my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not breath; had the feeling of being squeezed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on 15Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 25Jan2021 and experienced AFib, diabetic, COPD, stomach issues, chest pains and fever. About 20 minutes after the first dose, I had chest pains, from one side clear across the other side. She took a nitro, and had fever over a 100°F for 24 hours on Jan2021. She received second dose on 15Feb2021 and experienced they had her get an EKG. Patient felt squeezed, she could not breath on Feb2021. Her oxygen level and blood pressure were both fine on Feb2021. She had the feeling of being squeezed on Feb2021. Her chest started hurting at 3:50 a.m. (16Feb2021) this morning, stomach hurts like doing flip flops inside her. She did not have anything that would aggravate it. The outcome of the events was unknown. The events was reported as non-serious. Information on the batch/lot number has been requested.
74 2021-03-02 heart rate increased queasy stomach hot flash rapid pulse metalic taste
74 2021-03-03 lightheadedness 10:00 patient received second pfizer vaccine 10:40 reported feeling a flushing sensation x 1 approx... Read more
10:00 patient received second pfizer vaccine 10:40 reported feeling a flushing sensation x 1 approx 10:30, provided bottled water to drink, denies any difficulty breathing, throat swelling, or tongue swelling 11:00 finished bottle of water feeling fine left vaccine clinic accompanied by her husband 11:30 returned to vaccine clinic c/o thick tongue and difficulty swallowing, denies difficulty breathing. Sent to ED. ED note states that patient presented after "near syncopal episode" after developing lightheadedness and flushing after vaccination. Similar episode an hour later (prompting return to medical center). Denied chest pain or shortness of breath on presentation to ED. Described difficulty swallowing and "thick tongue" leading to her presenting back to clinic, but asymptomatic when arrived to ED. Oropharynx free of any swelling. EKG done but only showed sinus bradycardia. Patient observed multiple hours then discharged without any medical intervention taken.
74 2021-03-03 low platelet count, anaemia 4 weeks severe out of control pains , myalgias, arthralgias, weight loss, thrombocytopenia, anemia, ... Read more
4 weeks severe out of control pains , myalgias, arthralgias, weight loss, thrombocytopenia, anemia, elevated inflammatory markers. currently improving on prednisone.
74 2021-03-03 palpitations heart palpitations/ palpitations; patient decided on her own to take Levoxyl sublingually / started ... Read more
heart palpitations/ palpitations; patient decided on her own to take Levoxyl sublingually / started taking a little more/ started increasing the thyroid medication; This is a spontaneous report from a contactable consumer (patient) received via the Medical Information Team and the Pfizer-sponsored Program. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number: EL1283 and expiry date unknown), via an unspecified route of administration on 20Jan2021 (at 74 years old) at a SINGLE DOSE for COVID-19 immunization, "for fun, for fear"; and levothyroxine sodium (LEVOXYL Tablet), orally from 12Nov2020 to an unspecified date and sublingually at the beginning of Jan2021 (also reported as 20Jan2021) to an unspecified date at 0.25 mg, daily (she would take half of the tablet in the morning and half at night) for hypothyroidism. The patient's medical history included hypothryroidism from an unknown date. Patient's height used to be five foot three with weight: between 140 to 150 pounds, usually around 145 pounds. Concomitant medications included Magnesium Malate at 1000mg and at 200mg (lot number: X002OISTE1 and expiration date: Aug2023). She got Magnesium the heart doctor told her to get. She stopped taking it on 22Jan2021, two days after the first episode on the 20Jan2021. Patient previously had problems with another thyroid drug, it was a natural thyroid medication called NP THYROID and she had palpitations on that one. The drug was not as standardized because it is natural thyroid. She started it in 2019 and took for a year and half. She was on a higher dose, 30mg originally and dropped down to 15mg or .25gram because it was "too much." The pharmacy sent a notice out that a dosage was too high in May or Jun. Then in Sep the dosage was too low. She asked pharmacy about the lot number and they said they didn't put it on there. She got it from (Pharmacy name withheld). RX number: 1677890-07298. Manufacturer: (Company name withheld). The dose amount had dropped, and she wasn't getting enough of the drug and her TSH had gone very high. That was causing the palpitations. Then she was switched to levothyroxine sodium. On 20Jan2021, patient experienced heart palpitations. It was reported that at the beginning of Jan2021 (also reported as 20Jan2021), patient decided on her own to take levothyroxine sodium sublingually and she experienced heart palpitations. Patient confirmed that this was not prescribed to be taken sublingually. Patient asked if taking levothyroxine sodium sublingually increase its potency. Also, on 20Jan2021, she received the first dose of the Pfizer Covid vaccine. Her thyroid levels taken this past Friday (29Jan2021) were normal. Patient asked if taking the Covid vaccine with levothyroxine sodium cause palpitations. She wanted to know if there is data on taking levothyroxine sodium sublingually. She wanted to know if it has more of an effect and wondered if taking levothyroxine sodium sublingually might have effected it. She doubts if Pfizer has studied it sublingually, but would that have increased the potency of the levothyroxine sodium? Maybe she got more than she was getting before. On 20Jan2021 she received Pfizer's COVID19 Vaccine. She started having palpitations that night and she was not sure if the vaccine had anything to do with it. The palpitations are ongoing. Some days they get worse and other days they are ok. She thought she was low on levothyroxine sodium, so she started taking a little more. She knew she was supposed to call the doctor. The day after she got palpitations, she started increasing the thyroid medication and it didn't seem to help. Over- the- counter Zinc, Magnesium, and Potassium helped. Zinc seemed to have most effect at trying to reduce them. It was reported that patient took Zinc 30 Orotate (lot number: 210606, expiration date: Nov2020). She took it on three occasions when she had it bad. Within a few hours after she took it the palpitations calmed down. Patient also took Potassium (lot number: 8BO3217 and expiration: Mar2003). She has only taken it twice since the palpitations. She doesn't take those normally except for the Magnesium. She went to the doctor yesterday, but she didn't see the doctor and only saw the nurse. She underwent thyroid test on Friday, 29Jan2021 and it was within range. The TSH was not high, meaning she was getting the correct amount. She doesn't know how quickly taking the half thyroid pill would have effected it at that point. Supposedly she is within range, but still was having palpitations. Some days are really bad and other days not so bad. The levothyroxine sodium is the same prescription bottle. She just switched from taking it orally to sublingual. She took it orally for the first several months and then switched to sublingual, for both, she would take half of the tablet in the morning and half at night because she was so reactive to medication. She was concerned if she should get the second dose of COVID-19 vaccine because "you never know." The patient further reported that she saw the cardiologist in the fall, and he did EKG and didn't find anything unusual. She is going to go see him again tomorrow because her other doctor said if the heart palpitations are bad enough, she needs to go to the ER and get EKG. She just had EKG in the fall. She knows it was a reaction to something. As soon as she started getting more thyroid medication in her, it went away. The action taken in response to the event for levothyroxine sodium was unknown and for BNT162B2 was not applicable. Outcome of the event heart palpitations/ palpitations was not recovered.
74 2021-03-03 hypertension initially had low grade fever, headache, chills that started 6-8 hours after the vaccine then abated... Read more
initially had low grade fever, headache, chills that started 6-8 hours after the vaccine then abated, went for routine physical examination and found to be hypertensive, BP over 140 systolic taken 3 times in the primary care physician's office. Later began doing BP monitoring at home, BP running from 130-140 with a high of 154 systolic, diastolic 70-78. There have been no associated headaches, dizziness, etc.
74 2021-03-03 chest pain pain in chest through back; tongue swelled up; difficulty swallowing; This is a spontaneous report f... Read more
pain in chest through back; tongue swelled up; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number EL9764/EL9264), via an unspecified route of administration in the right arm on 01Feb2021 09:45 at a single dose for covid-19 immunization. Medical history included ongoing three stents in her artery, heart issue where they took test to see if she had a heart issue, and everything came back negative, high blood pressure, high cholesterol, overweight, penicillin allergy, IV iodine allergy, allergy to pollens, inhalants, dust and animals. There were no concomitant medications. The patient previously took phenytoin (DILANTIN), bacitracin;neomycin sulfate;polymyxin b sulfate (NEOSPORIN) and cefalexin (KEFLEX); all of which patient experienced allergies/ drug hypersensitivity. On 01Feb2021 09:45, immediately after receiving the vaccine, her tongue swelled up, she had difficulty swallowing, and she has a pain in her chest that went through to her back. The patient was sent and admitted to the ER and got an IV shot injection of diphenhydramine (BENADRYL) that got tongue back down. She didn't need an Epi pen, it wasn't that bad. They took the test to see if she had a heart issue, and everything came back negative. The patient was advised by the head of ER that she shouldn't get the second shot because of the reaction. It could be more severe with the second dose he said. The outcome of the events was recovered on 01Feb2021.
74 2021-03-04 chest pain midsternal pain, blood in urine, hyperglycemia
74 2021-03-06 hypertension pt felt flushed, slight sob, initial bp at 202/10, gradually decreased, continued to be slightly hig... Read more
pt felt flushed, slight sob, initial bp at 202/10, gradually decreased, continued to be slightly high, last bp at 177/82, per client, pt due for bp med tonight. Per MD, ok for pt to go home, pt no longer felt flushed.
74 2021-03-07 chest pain Patient reported sharp chest pain approximately 30 minutes post vaccination. Patient was transferre... Read more
Patient reported sharp chest pain approximately 30 minutes post vaccination. Patient was transferred to recumbent chair for monitoring, attached to EKG, vital signs and 50 mg diphenhydramine administered IM to left deltoid. Transfer of care to rescue squad for transfer to local ER.
74 2021-03-07 palpitations Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 2/28/2021 7:38 AM E... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 2/28/2021 7:38 AM Expand AllCollapse All COVID VACCINE CLINIC 2/26/2021 Patient: Date: 2/26/2021 MRN: 10046638 Subjective Patient is a 74 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience difficulty breathing and heart racing. She denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms and respiratory distress. PMH includes parkinson and items below. No hx of DM. Past Medical History: Diagnosis Date ? Depression ? GERD (gastroesophageal reflux disease) ? Hyperlipidemia ? Hypothyroidism ? Osteoarthritis ? Pain, chronic ? Unspecified cataract ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath (and feeling palpitations. ) Patient denies chills, fever, malaise/fatigue, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, wheezing, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/26/21 0304 02/26/21 1457 BP: 123/72 123/62 Pulse: 76 73 Resp: 16 SpO2: 97% 97% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait abnormal (walks with cane and uses seated walker). Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. 0305 pm: pt walked around in bay with her cane. She was able to ambulate w/o difficulty. Reports slight lightheadedness but states this occurs with her intermittently /chronically. Nothing worse. Pt given snack after return to bed for further observation. She had water given to her earlier prior to ambulation. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Monitored in bay for approx 40 minutes. She reports great improvement after snack. She feels well. Suspect stress response to vaccine. No dizziness, lightheaded or palpitations/sob with ambulation. She would like to go home. Husband is with her today and is able to be with her. She left in her seated walker, pushed by husband. Accompanied out by staff member. Follow up with pcp if not improving. Discussed reasons for ED visit. APRN Electronically Signed 2/26/2021 3:11 PM
74 2021-03-07 hypertension, cerebral haemorrhage Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory fa... Read more
Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter.
74 2021-03-08 ischemic chest pain Approximately 50 hours after receiving the second dose, I experienced angina in the area of the left... Read more
Approximately 50 hours after receiving the second dose, I experienced angina in the area of the left cardiac artery . This angina lasted all day and into the night. It was gone by the following morning.
74 2021-03-08 body temperature decreased Chills, Nausea, Diarrhea, Low Temperature (96) Symptoms lasted for 8 hours
74 2021-03-08 chest pain First two days: slight dizziness, nausea, chills, sore arm - only lasting about 1/2 hour each day. ... Read more
First two days: slight dizziness, nausea, chills, sore arm - only lasting about 1/2 hour each day. Evening of day two: Headache started. and continues each day getting a little worse each day. Took Ibuprofen-helped slightly Day five: Bad headache all day and from previous night. Contacted doctor through MY Chart. He said persistent headaches with Pfizer vaccine were uncommon and suggested a treatment.. I declined as I had used that medication 30+years ago and didn't like it. Day six: Better Day seven: Better Day eight: Still with headache, sinus drainage, chest pain (like I was coming down with a cold) Day nine: No chest pain, drainage and headache, ringing in ears Day ten: More drainage and headache, ringing in ears
74 2021-03-09 chest pain Approximately 10 minutes after vaccination patient complained of substernal chest pain. No associat... Read more
Approximately 10 minutes after vaccination patient complained of substernal chest pain. No associated symptoms. No anaphylactic symptoms. Usually takes sublingual nitro but did not bring to vaccination site.
74 2021-03-09 chest discomfort Called patient to follow up on her reaction to the COVID vaccine administered on 3/4/21. She was tra... Read more
Called patient to follow up on her reaction to the COVID vaccine administered on 3/4/21. She was transported by EMS to the ER after having anaphylaxis to her second Pfizer vaccine. She states she was hospitalized in the ICU overnight and was discharged home this afternoon. Patient feels she is doing much better. She does note feeling very tired from all the medications they gave her. She plans to call her PCP on Monday to schedule an appointment and has follow up scheduled with allergy specialist. She denies any further questions or concerns. Patient is appreciative of phone call. Progress Notes: 3/4/2021 Subjective Patient is a 74-year-old female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30-minute waiting period after the injection, the patient began to experience hoarse voice. She denied rash, difficulty breathing, difficulty swallowing, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms. PMH of anaphylaxis x 3, with one hospitalization. ALLERGY REVIEW OF SYSTEMS: Patient complains of chest tightness (she later developed chest tightness when she was in the bay prior to epi-pen administration.) Patient denies chills, fever, malaise/fatigue, facial swelling, cough, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain Hoarse voice.: Negative for nausea: + lightheaded.: Previous Reactions: anaphylaxis to medications. Never to vaccines. Pt's husband with her today. He states she progresses rapidly with her anaphylaxis and wishes for her to get epi pen now based on her symptoms. She typically starts out this way. Vitals: 03/04/21 1135 03/04/21 1140 BP: (!) 187/100 (!) 163/95 Pulse: 93 95 Resp: 18 16 SpO2: 100% 100% Physical Exam Constitutional: Appearance: She is well-developed. She is not toxic-appearing or diaphoretic. Comments: flushed HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway. Voice is hoarse. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: benadryl 50 mg IM R leg antihistamines and epinephrine x 1 at 1136 in L leg Follow up response to treatment: good. She started to have return of symptoms when AMR was leaving with her. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Anaphylaxis (dyspnea, stridor, drooling, tongue swelling) Pt with early onset of presumed anaphylaxis that responded well to epi-pen. Pt sent to ED for closer observation/treatment via AMR. Husband voiced great appreciation of pt's care today. 3/4/2021 11:40 PM Addendum: ED charge nurse, RN was notified of patient coming.
74 2021-03-10 chest discomfort 10 minutes after injection, reported trouble breathing, tight chest, generalized itching, hives on c... Read more
10 minutes after injection, reported trouble breathing, tight chest, generalized itching, hives on chest and trunk, swelling of tongue and throat. Epi given to outer thigh, 8L O2 NC placed, Benadryl given IM. 911 called and transported to GS ED via ambulance
74 2021-03-10 ischaemic stroke 74 y.o. female with a history of hypertension and hyperlipidemia who was admitted to this hospital o... Read more
74 y.o. female with a history of hypertension and hyperlipidemia who was admitted to this hospital on February 25, 2020 4 hours after the development of left-sided weakness. She was found to have an acute ischemic stroke. She has had slow progression with therapy but is now able to ambulate with a walker. She is in need of further rehab, hence the transition to swing bed. She denies any new complaints today, including headache, chest pain, shortness of breath, palpitations or feelings of tachyarrhythmias. The sensory deficits on the left side have improved in particular in her left upper extremity. She is noting some improvement as well and strength. No new focal neurological deficits
74 2021-03-10 palpitations Forty-five minutes after the injection my heart began to race to the extent that it was very alarmin... Read more
Forty-five minutes after the injection my heart began to race to the extent that it was very alarming. After an hour or so I took a very mild tranquilizer (.25 mg of clonazepam), which I take rarely (my doctor only prescribes .5 mg, 30 pills per year), and my heart calmed down. I also had "standard" side effects, namely, headache and sore arm.
74 2021-03-11 fibrin d dimer increased Patient calling to report she received second COVID-19 vaccine 3 days ago. Patient is having difficu... Read more
Patient calling to report she received second COVID-19 vaccine 3 days ago. Patient is having difficulty functioning since vaccination. Patient is fatigued, body aches. Patient states that she is having a "hard time getting around" due to exhaustion. Able to stand and walk without difficulty. Able to do some of normal housework. No fevers. PCP performed labs - D-dimer elevated, troponin negative, EKG normal. Sent to ED for concern of PE. CTA-PE negative. D/C'd home in stable condition.
74 2021-03-12 palpitations Heart was raising.
74 2021-03-14 fibrin d dimer increased, pulmonary embolism Patient developed B PE's within a week of the vaccination. She has had a DVT before, but no other k... Read more
Patient developed B PE's within a week of the vaccination. She has had a DVT before, but no other known risk factors
74 2021-03-15 very slow heart rate 1320: received initial injection of Pfizer 1330-1335: patient was not responding normally to husband... Read more
1320: received initial injection of Pfizer 1330-1335: patient was not responding normally to husband and caregiver 1335: our initial evaluation revealed she was semi-conscious, initially looking up when her name was called but then she stopped responding. Pulse ox was 99% on 2L O2 (chronic use), pulse 35. Blood pressure could not be measured. EMS was called. Pupils were both reactive to light but patient was not tracking. Despite sternal rub and physical stimulation, patient was not responding. She exhibited excessive salivation but no tongue swelling. Cardiac auscultation revealed bradycardia but regular rhythm. Lung sounds were normal bilaterally, no wheezing. 1340: EMS arrived, no vitals were obtained initially, patient taken to ED
74 2021-03-15 chest discomfort Action taken: Pt brought to assessment tent 10 minutes after vaccination given c/o chest heaviness/f... Read more
Action taken: Pt brought to assessment tent 10 minutes after vaccination given c/o chest heaviness/feeling odd, along with the shakes and chills. VS taken and doctor notified of patient arrival. Reviewed Pt. History and any medical problems. Pt stated she is currently being treated for Sinus Problems and saw her doctor yesterday who encouraged her to get her vaccination today. She is on a Prednisone taper, and takes HCTZ for BP, and had a cardiac procedure done last year for chest discomfort, and nothing was found. Discussed with doctor the need to call EMS. Pt resistant to this but explained that they would assess her and then she could decide what kind of treatment from there. Pt still resistant to having EMS called, but call placed as per protocol. EMS Arrived and report given. Pt still resistant to being transported to hospital, after approx 15 minutes EMS convinced patient of the risks and needs of being transported versus the risks of driving there herself. Pt transported via EMS hospital.
74 2021-03-16 heart rate abnormal 1. After few minutes numbness on right side of body for 2 days. 2. After 3 days erratic blood pressu... Read more
1. After few minutes numbness on right side of body for 2 days. 2. After 3 days erratic blood pressure and rate, now at day 17 and this shortness of breath, dizziness and erratic heart beat and rate continues...my heart rate of 160 is totally out of my norm.
74 2021-03-16 heart rate decreased, pallor Approximately 10 minutes after patient received her Pfizer vaccine she stated that "she need to move... Read more
Approximately 10 minutes after patient received her Pfizer vaccine she stated that "she need to move her bowels." Then she started to become nauseous and turned pale. EMS assessed her. Patient's heart rate dropped. Patient was lying down. Patient was then taken to the hospital in stable condition.
74 2021-03-16 chest discomfort, heart rate increased While enroute home on the bus about 2:30 pm heart rate suddenly became rapid, chest tightened and b... Read more
While enroute home on the bus about 2:30 pm heart rate suddenly became rapid, chest tightened and breathing Became labored ? because of my past sensitivities, I carry Benedryl. I took one and by the time I arrived at destination symptoms had subsided some ? five hours later chest tightness returned - so kept taking Benedryl at 6 hour intervals until 10 pm March 11 when ease of breathing returned - called doctor morning of March 11 and was told to continue Benedryl until symptoms improved
74 2021-03-17 deep vein blood clot DVT blood clot in leg
74 2021-03-17 chest discomfort, heart rate increased, oxygen saturation decreased Patient brought back to chemo room for 1st dose of Pfizer BioNTech vaccine. LOT: ER2613 Man Exp: 07... Read more
Patient brought back to chemo room for 1st dose of Pfizer BioNTech vaccine. LOT: ER2613 Man Exp: 07/20/2021. Patient appeared anxious about receiving vaccine but was alert and oriented x4 and ambulatory with no other complaints. No previous reactions to vaccinations per patient. Patient received Covid vaccine at 1002, patient started coughing and complaining of chest tightness at 1005 with auditory wheezing. First Epi given at 1005 and O2 was placed on patient via face mask at 15L. 911 was then called. O2 saturations at beginning of reaction in the high 80's and dropping, HR 150's. Unable to obtain blood pressure throughout episode at clinic. IV access attempted and unsuccessful x1 at clinic. Saturations continued to drop into low 70's with no improvement of respiratory symptoms. Decision was made to give second Epi and was given at 1010. Before second attempt to establish IV access EMT arrived. Patient was transferred to stretcher and taken to Ambulance via EMS staff.
74 2021-03-17 cerebrovascular accident Patient had a large stroke. Seizure on 01/30/2021 after first dose of Pfeizer vaccine on 01/29/2021.... Read more
Patient had a large stroke. Seizure on 01/30/2021 after first dose of Pfeizer vaccine on 01/29/2021. Patient was 74 years old at the time she received the vaccine.
74 2021-03-18 pulmonary embolism, deep vein blood clot Patient received her first covid vaccine and started developing SOB and DOE 2 days later. she then w... Read more
Patient received her first covid vaccine and started developing SOB and DOE 2 days later. she then was diagnosed with bilateral PE and left leg DVT on 3/6/21
74 2021-03-20 nosebleed Nose bleeding after 15 hours of vaccine
74 2021-03-20 chest pain Pain on right side of rib cage and right side of right breast. Pain for approximately 1 week prior ... Read more
Pain on right side of rib cage and right side of right breast. Pain for approximately 1 week prior to seeing primary care MD.
74 2021-03-21 blood clot, deep vein blood clot Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot.; several SVT &DVT in ... Read more
Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot.; several SVT &DVT in multiple veins & artery of left foot; several SVT &DVT in multiple veins & artery of left foot; Pain & swelling of foot; Pain & swelling of foot; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 12:00 AM (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Some antibiotics cause autoimmune issues, all sulphate drugs, narcotics. Historical vaccine included first dose of Pfizer COVID 19 vaccine (lot_number=EL3249) on 22Jan2021 12:00 AM administered in Right arm. Concomitant medications included thyroid (NATURE THROID) and multiple vitamin, taken for an unspecified indication, start and stop date were not reported. The patient experienced Plantar thrombosis - several SVT &DVT in multiple veins & artery of left foot. Pain & swelling of foot, all on 06Mar2021 01:00 AM with outcome of not recovered. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received for events included given Eliquis to avoid further clotting. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
74 2021-03-21 palpitations She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, st... Read more
She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, started shaking and feeling like restlessness. She went to bed and covered up under lots of covers, and just froze. She put on extra clothes, layers of blankets and her legs felt swollen, painful. She kept having to urinate a lot, could not sleep, was awake all night, her arm started hurting as well, could not lay on that side, and then started getting cold/hot flashes. She felt as though her heart was racing, and her brain as well trying to figure out what was happening. Her husband took her temperature in the morning and it was 101.9, which her normal is 97.9. At that point she was exhausted from being up all night, and was frightening and couldn't stop trembling all night long into Saturday. When day broke on Saturday shew as not able to get out of bed for the entire day. She could not eat, had no appetite and drank water day. On Sunday she felt a little better, ate breakfast and the rest of the day went okay other than being exhausted. This morning, 3/22/21, she still feels lofty, is able to function and feels a little removed/foggy feeling. She is still not feeling completely well, but is on her way. Not steady on her feet yet. She took some Bayer aspirin for the symptoms.
74 2021-03-22 haemoglobin decreased, blood glucose increased excruciating pain all over the body and headache which started after covid vaccine on 3/8 Pfizer. Sy... Read more
excruciating pain all over the body and headache which started after covid vaccine on 3/8 Pfizer. Symptoms started 3/12. Stopped the crestor and only the leg cramps stopped. Tylenol and baclofen did not help. Went to ER for pain and was given IV dilaudid and toradol which helped at the time. She was rx norco. She tried 2 tabs at a time and threw up. She is just takin g1 tab q4 hrs now which helps with the body aches but not the headache.
74 2021-03-22 heart rate increased, blood pressure increased within 1 1/2 hrs of the shot fast heart rate of 135; blood pressure 205/101 went to ER; This is a sp... Read more
within 1 1/2 hrs of the shot fast heart rate of 135; blood pressure 205/101 went to ER; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6203, expiry date not reported) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension, COPD (chronic obstructive pulmonary disease), AFIB (atrial fibrillation), cardiac arrest, asthma, PMR (polymyalgia rheumatica), LBBB (bundle branch block left) from an unknown date and unknown if ongoing and ICD Implant (implantable defibrillator insertion) all from unknown dates. The patient previously took ciprofloxacin [ciprofloxacin lactate], norvasc, lidocaine and experienced allergies (Known allergies). The patient experienced within 1 1/2 hrs of the shot fast heart rate of 135 and blood pressure 205/101 went to ER on 24Feb2021 at 16:45. The events were reported to have caused hospitalization. The patient underwent lab tests and procedures which included blood pressure measurement: 205/101 and heart rate: 135 both on unspecified date. Therapeutic measures were taken as a result of within 1 1/2 hrs of the shot fast heart rate of 135 and blood pressure 205/101 went to ER which was reported as Ae treatment: EKG and Heart Monitoring. Outcome of the events was Recovered/Resolved with Sequel.
74 2021-03-23 heart attack, troponin increased Patient received 2nd COVID-19 vaccination on 3/13/21. Manufacturer and lot # of vaccine not availab... Read more
Patient received 2nd COVID-19 vaccination on 3/13/21. Manufacturer and lot # of vaccine not available as administered at outlying clinic/facility. Date of 1st vaccination also unknown. Patient presents to ED after fall. Patient states that she has had significant weakness since receiving 2nd COVID vaccination. Patient states prior to COVID vaccine she was in her normal state of health. Patient troponin was elevated at 0.99. Patient denies any chest pain or shortness of breath. Patient diagnosed with non-STEMI. Treated with medical management including heparin drip and continue aspirin + Plavix + statin therapy. Patient was discharged to rehab facility on 3/18/21.
74 2021-03-23 heart rate increased rapid heart beat; This is a spontaneous report from a contactable consumer, the patient. A 74-year o... Read more
rapid heart beat; This is a spontaneous report from a contactable consumer, the patient. A 74-year old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the right arm on 27Jan2021 at 00:30 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included asthma; allergies to sulfur drugs, papaya and mango. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included metformin, salbutamol sulfate (PROAIR), ergocalciferol (VIT D), montelukast, losartan. There were no other vaccines within 4 weeks of the vaccination. On an unspecified date in 2021, after the first vaccination, the patient experienced rapid heartbeat for four days. The patient was not treated for the event. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of rapid heartbeat was resolving.
74 2021-03-24 chest discomfort, palpitations Shortness of breath, dizzy/lightheadedness, chest heaviness. Occurred nearing the end of 15 minut... Read more
Shortness of breath, dizzy/lightheadedness, chest heaviness. Occurred nearing the end of 15 minutes waiting period following vaccine administration. Pt began feeling short of breath, dizzy upon standing, chest heaviness and heart racing. Breathing slowed and eased, chest heaviness resolved and Pt reported feeling back to normal within 40 minutes following initial event.
74 2021-03-24 pallor, loss of consciousness, hypotension she had low pressure; she passed out at one point; She is very pale in her face.; lightheaded/Dizzy;... Read more
she had low pressure; she passed out at one point; She is very pale in her face.; lightheaded/Dizzy; She felt very bad the second day; She had an allergic reaction; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 09:45 (Batch/Lot Number: EL9262) as single dose for covid-19 immunization. Medical history included seizure (she had convulsions as a child). There were no concomitant medications. The patient experienced she passed out at one point on 03Mar2021, she had low pressure on 03Mar2021 at 08:00. The patient also experienced she is very pale in her face, lightheaded/dizzy, she felt very bad the second day and she had an allergic reaction on Mar2021. Reporter states She had an allergic reaction. The first day she felt fine, the second day she had low pressure and she passed out at one point and the rest of the day she had low blood pressure. She felt very bad the second day and Monday was the same and she is still feeling light headed and dizzy today. She says the first dose was given on the 05Feb2021 and her second dose she just had that on 02Mar2021 and that is the dose she is reporting about today. She says it was 03 Mar when she started having low blood pressure and passed out. She says she is still light headed and dizzy today, that is ongoing. She has not checked her blood pressure today but she feels like it is still low. She is very pale in her face. The patient underwent lab tests and procedures which included blood pressure measurement: low pressure on an unspecified date (she had low pressure). Outcome of she had low pressure and lightheaded/Dizzy was not recovered. Outcome of all the other events was unknown.
74 2021-03-25 chest pain, blood pressure increased Malignant hypertension Blood Pressure up to 220/108 within 12 hours after first dose vaccine Chest ... Read more
Malignant hypertension Blood Pressure up to 220/108 within 12 hours after first dose vaccine Chest pain, SOB, headache and dizziness, ankles and wrists aches.. sever spinal pain. Debilitating pain and weakness
74 2021-03-25 cerebrovascular accident, chest discomfort PATIENT HAD CHEST PRESSURE, DIZZINESS, AND DOUBLE -VISION 5 MINUTES AFTER VACCINE ADMINISTRATION. AT... Read more
PATIENT HAD CHEST PRESSURE, DIZZINESS, AND DOUBLE -VISION 5 MINUTES AFTER VACCINE ADMINISTRATION. ATIENT TO ED, ADMITTED TO ICU FOR PROBABLE CVA
74 2021-03-28 skin turning blue Patient reviewed vaccination at 1:20pm. She was observed for one hour per MD. At 5:18, she became un... Read more
Patient reviewed vaccination at 1:20pm. She was observed for one hour per MD. At 5:18, she became unresponsive in her wheelchair and became blue with no palpable pulse. Patient had a DNR status and was not revived.
74 2021-03-30 heart rate increased Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakn... Read more
Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right arm on 22Feb2021 05:00 (Lot Number: EN6203) at single dose for COVID-19 immunisation. Medical history included rapid heart beats control by medication, anxiety. Concomitant medications included metoprolol; alprazolam; and other vaccine (lot number: EL8982) received on 22Feb2021 in arm. The patient previously took codeine and experienced allergies; received bnt162b2 on 26Jan2021 (lot number: EN6203) in arm for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Started with rapid heart beats, lungs sore, headache, sore all around. Chest wall was painful. Weakness. Most of all systems went away, after the week of March12. Except the bad headache. They were still present. Events all started from 22Feb2021 05:00, resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Events were considered non-serious per reporter.
74 2021-03-31 loss of consciousness a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the si... Read more
a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the side that she got the vaccine was cold; Second dose: pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2, dose 2, via intramuscular, administered in right arm on 16Mar2021 10:00 AM (Lot Number: EN6204; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included eczema from 2017, she had eczema all over her back and arms and had mild allergies to mold and juniper. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 at the age of 74-year-old on 23Feb2021 at 10:00AM (lot number: EN6198, Expiry: Jun2021) intramuscular injection in left arm and experienced pain at injection site and couldn't sleep. The patient also took Prolia shots for arthritis. The patient experienced headache, nausea, pain at injection site and hand on the side that she got the vaccine was cold on 16Mar2021, passed out, weakness and disorientation when walking on 17Mar2021, a little tired on 18Mar2021. The clinical course included: The patient was calling about the second vaccine that she got on 16Mar2021 (Tuesday). She was calling about the after effects. They were quite huge. She had a headache, nausea, weakness, and disorientation when walking. Stated she obviously had pain at the site of injection. Stated some of it was her own fault, and at first she felt fine. On the same day that she got her second dose of the covid vaccine, she had a glass of wine and was not too hungry. She ate a little that evening. The next morning she passed out. Clarified that she had two glasses of wine, not one. Caller's daughter was a doctor. Caller referd to her daughter as doctor daughter. Stated that she told her daughter about what happened. Her daughter told her it was because she was dehydrated. Her daughter told her that it was called vagus something or another. Her daughter was not there with the caller. Her daughter called it vagus something, she does not remember. Her daughter told her that it had to do with inflammation and her immune system. Caller stated she also has arthritis. Her daughter told her that she was stupid for drinking wine after receiving the second dose of the covid vaccine and not eating a full meal. Whenever she passed out and fell, she did not hurt herself but it was a wake up call. She realized she was vulnerable. She was calling because she did not know why no one told her to drink a lot of water after receiving the vaccine. She got a Prolia shot in July and the nurses told her to drink a lot of water. She was asking why the nurses who gave her the covid vaccine are not saying that to people. Her daughter told her to call the doctors office about this, and she told her daughter that it was over with now, she's 95%, she was a little tired on 18Mar2021. She was unconscious for 15 seconds per her husband. Her husband was shouting her name, and she did not hear anything. She wanted to call and report that the nurses should tell people to drink water. One more thing, her daughter told her that the covid vaccine was slowly released. About 10 hours after receiving the second dose of the covid vaccine her hand on the side that she got the vaccine was cold. She got the vaccine about 10AM, and about 10PM at night is whenever her hand got cold. She had pain at the injection site where she had the first dose of the vaccine too. She had more pain at injection site after the second dose of the vaccine. It was not awful, but only if she pressed on it. Clarified that she gets Prolia shots twice a year for her arthritis. Luckily whenever she started to get dizzy, she braced her self, whenever she fell, she did not fall from an upright position. She was crouched over, and fell against trays that fell with her. Her doctor daughter told her that inflammation was because of her immune system. One other thing was that she has been stung in the past and had extreme reactions from yellow jackets in the 90's. She thought her immune system was sensitive. One other things related to her autoimmune from 3 years ago. She moved to a city in 2012. Everyone told her after 5 years she would develop allergies. In 2017, she had eczema all over her back and arms. It was not just like a topical thing where she scratched and itched, it was under her skin. She went to a dermatologist and he took a biopsy, but the results just said eczema. She went to an allergist, he finally found a space on her underarms where he could do a test. The test showed that she had mild allergies to mold and juniper. Juniper is a tree that they have there, she has one in her back yard. Her allergy was very mild. She tried everything, and in 4 months it went away. Now she just latherers her skin with coconut oil. Her diagnosis that this autoimmune issue was related her immune response from the yellow jacket reaction is a self diagnosis. A doctor had never told her this, this was coming from her own self. Clarified that she is calling about the second dose of the pfizer covid 19 vaccine. Headache: It was not a bad headache, it was more like pressure all across the top. Whenever she went to sleep, the headache started. She got the second dose of the covid vaccine on 16Mar2021. She had a little bit of a headache this morning. A cup of coffee with milk made it better. Nausea: It started whenever she did not want to eat dinner. She could tell her stomach was not right. The nausea and headache started together about 12 hours after her vaccine at 10:00 PM. Weakness: She noticed weakness on the next day whenever she got up to use the bathroom. Clarified as the early morning of 17Mar2021. Her weakness was about 90 percent resolved. Disorientation when walking: Clarified that her disorientation was in reference to walking only right before she fell. She was not mentally disoriented. Mentally she knew that she was not doing well. Second dose: pain at injection site: The pain only lasted for about 2-3 hours. It was now absolutely minimal. She would have to press on it to feel anything. Her hand on the side that she got the vaccine was cold: She got the second dose of the covid vaccine around 10:00 AM, and noticed her hand was cold about 5:00 PM., about 7-8 hours later. Whenever she went to bed, she was cold. She thought that it resolved by the next morning. The morning after receiving the second dose of the covid vaccine, she passed out: She passed out about 8:15 AM. The outcome of the events headache, nausea, weakness, pain at injection site was recovering. The outcome of the events disorientation when walking and her hand on the side that she got the vaccine was cold was recovered on 17Mar2021. The outcome of the other events was unknown.
74 2021-04-01 fainting, loss of consciousness Auto Accident - syncope - Ambulanced to Hospital. Passed out and hit a tree, totaled vehicle with n... Read more
Auto Accident - syncope - Ambulanced to Hospital. Passed out and hit a tree, totaled vehicle with no memory of the event. CT without contrast, blood work, EKG, fluid given IV. Stayed about 3 hours and was released.
74 2021-04-01 blood clot, troponin increased, cardiac arrest, haemoglobin decreased, excessive bleeding, hypotension DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cardiac arrest (HCC) [I46.9] HOSPITAL COURSE: Patien... Read more
DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cardiac arrest (HCC) [I46.9] HOSPITAL COURSE: Patient is a 74 year old female who receives care through healthcare clinic and second healthcare clinic with past medical history of HTN, CKD, cardiomyopathy/congestive heart failure, atrial fibrillation on Pradaxa who presented to the ED 3/16 after suffering an out of hospital cardiac arrest at her dentist's office. Per report, patient had SBP in the 80s on arrival but was asymptomatic. Prior to start of any procedure (no reports of being given sedative medications), she became unresponsive. CPR was initiated and was found to be in asystole. She received 3 rounds of CPR with ROSC. CT head without acute abnormality. Chest XR showing mild vascular congestion and interstitial edema. Initial labs showing AKI, elevated liver enzymes, BNP >29,000, troponin 39, lactic acid of 11, INR of 6.6, PTT 62, APTT 87. UA with protein, nitrite, moderate blood. Urine culture ordered. Blood cultures ordered. In ED, patient was hypotensive requiring addition of vasopressors. Targeted temperature management was started. Ceftriaxone and flagyl started for possible urinary tract infection and aspiration. Patient with profound coagulopathy, INR increasing to 12.0 on arrival to the ICU. Two units FFP and vitamin K were given. Patient with escalating pressor requirements at this time so CT t/a/p was ordered showing multiple bilateral rib fractures, nondisplaced sternal fracture with small anterior mediastinal retrosternal hematoma, small right sided hemothorax, right chest wall hematoma, patchy bilateral airspace disease consistent with atelectasis/infiltrate/aspiration, diffuse GGO consistent with interstitial edema, enlarged pulmonary arteries consistent with pulmonary hypertension, cholelithiasis. FDP elevated and 2 units of cryoprecipitate given 3/16. Hemoglobin decreased to 5.9 3/17 with INR of 5.4. Two additional units of FFP and additional dose of vitamin K ordered. Two units RBCs ordered. CTA thorax and abdomen 3/17 re-confirmed hemothorax and chest wall hematoma but no active bleeding noted. CT bilateral LE showed no evidence of hematoma. Trauma consulted who recommended chest tube placement. Overnight 3/16-3/17, patient also noted to have seizure activity on EEG and patient loaded with Keppra. Head CT 3/17 negative for hemorrhage or other acute processes. Patient remained in status epilepticus 3/17am and additional Keppra load was given and neurology consulted. Received Praxbind for continued bleeding/coagulopathy. 3/17pm went into PEA arrest with 10 minutes of CPR with ROSC. Bronchoscopy following ROSC noted evidence of bleeding from multiple areas, clots removed. MRI brain showing diffuse anoxic brain injury. Propofol stopped 3/19am. After goals of care discussion this morning, all first degree relatives (daughter and son) all in agreement to transition to comfort care measures. I received call from bedside RN that patient had passed away. On exam, no heart or breath sounds appreciated upon auscultation for 2 minutes. No spontaneous movement or chest rise noted. No pulse palpated for two minutes. Pupils fixed and dilated. No response to noxious stimuli. Time of death 1400 3/20/2021.
74 2021-04-01 hypotension weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated p... Read more
weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated prior to this admit; shaking; chills; severe headache; right mid and low back pain; high fever up to 103 degrees; Not able to get out of bed except to get to nearby bathroom; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 74-years-old via an unspecified route of administration, administered in arm left on 05Mar2021 15:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included anal cancer (h/o anal cancers/p chemo & RT2013), hypertension, hypothyroidism and new fe deficiency anemia dx during this admit from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient has known allergies to Ampicillin, clindamycin, trilafon, imipramine. The patient reported that 4.5 days after 1st dose of Pfizer vaccine on morning of 10Mar2021 09:00, the patient woke up with shaking chills, severe headache, right mid and low back pain, high fever up to 103 degrees within 1/2 hr of onset and not able to get out of bed except to get to nearby bathroom to use toilet when needed. The patient took Tylenol 500 mg up to 5 doses by 10:00 am of 11Mar2021 when fever would not abate; the patient was weak and lightheaded on an unspecified date and since lived alone called a number to take her to ER. On an unspecified date, her blood pressure was low 80's to 90's over 40's to 50's all thru night and 1000 more mg of Tylenol was given at 4:00 am and fever then lowered to 99 or 100. Full infectious work up negative for bacterial sources including abdominal and pelvic cat scan, abdominal ultrasound, CXR, urine culture, she received 2 1/2 liters of IV fluid and IV Ceftriaxone and Flagyl in ER. In case bacterial cause which was not found including blood cultures, due to her BP still not improved by 5:00 am as she was dehydrated prior to this admit, she was admitted on medicine floor for 2 days. The patient underwent lab tests and procedures which included abdomen scan: unknown result on an unspecified date, blood pressure measurement: low 80's to 90's over 40's to 50's all thru night on an unspecified date; still not improved on an unspecified date, body temperature: high fever up to 103 degrees on 10Mar2021; 99 or 100 on an unspecified date, chest x-ray: unknown result on an unspecified date, culture urine: unknown result on an unspecified date, sars-cov-2 test: negative on 10Mar2021, ultrasound abdomen: unknown result on an unspecified date. Therapeutic measures were taken as a result of the events which included IV, fluids, 1 dose of 2 different IV antibiotics (Ceftriaxone and Flagyl) and Tylenol. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
74 2021-04-06 chest pain, ischemic chest pain, arrhythmia arrhythmia; pain in my chest, in my heart; pain in my chest, in my heart; This is a spontaneous repo... Read more
arrhythmia; pain in my chest, in my heart; pain in my chest, in my heart; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262) via an unspecified route of administration into the right arm on 11Feb2021 as single dose for COVID-19 immunisation. Medical history included glaucoma, diabetes, hypertension, cholesterol, diuresis, bone disorder, pain, back surgery and replaced right knee. Concomitant medications included atorvastatin (ATORVASTATIN) taken for cholesterol, furosemide (FUROSEMIDE) taken for diuresis, alendronate sodium (ALENDRONIC) taken for bone disorder, latanoprost (LATANOPROST) taken for glaucoma, sitagliptin (JANUVIA) taken for an unspecified indication, potassium (POTASSIUM) taken for an unspecified indication and celecoxib (CELECOXIB) taken for pain. On 11Feb2021, patient felt pain in her chest and in her heart. Patient underwent electrocardiogram (ECG) on 11Feb2021 and was told that she had arrhythmia. Patient was brought to the emergency room and was treated with Aspirin. Outcome of events was unknown.
74 2021-04-06 hypotension her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fl... Read more
her blood pressure was very low the next morning; she felt really weak; nausea; she lost a lot of fluids/I was so dehydrated; hadn't eaten anything; stated she started salivating and then threw up; stated she threw up once; she had a severe headache; she was shivering all evening and she couldn't get warm; she had body aches; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249, NDC number: Unknown, Expiration Date: May2021, Manufacturer: Unspecified) via an unspecified route of administration at right arm on 15Jan2021 at single dose for COVID-19 immunisation. Medical history of patient included knee pain and anxiety. Patient's concomitant medications included tramadol, paracetamol both 500 mg for knee pain and hydroxyzine hydrochloride (25mg tablet up to three times a day as needed by mouth, she does not take every day) for anxiety. On 15Jan2021 after vaccination patient experienced salivating and then threw up, stated she threw up once, severe headache, shivering all evening and she couldn't get warm, body aches, nausea, lost a lot of fluids/I was so dehydrated, hadn't eaten anything and her blood pressure was very low the next morning, she felt really weak on 16Jan2021. She required urgent care trip for IV fluids, "She was so dehydrated" and was "miserable" with her symptoms. She said she lost a lot of fluids and hadn't eaten anything. Patient wants to get the second COVID-19 vaccine dose because she is scheduled to have a knee replacement on 26Feb2021. She said she also had to deal with the pain in her knee, clarifying that is why she is getting a knee replacement. IV fluids (clarified as Saline), tylenol given as treatment. She reported when she got home she drank Pedialyte to try to rehydrate herself. She reported she went to urgent care on Saturday (16Jan2021), and by Monday 18Jan2021, she was feeling better, but she didn't golf on Tuesday, 19Jan2021. patient underwent lab tests and procedures which included blood pressure measurement which very low, influenza virus test and sars-cov-2 test was negative on 16Jan2021, blood test was fine. Patient said yes for investigation assessment. The outcome of event was recovered on 15Jan2021 for Increased salivation and Vomited and for all other event outcome was recovered on Jan2021.
74 2021-04-07 blood clot, pulmonary embolism On Apr 7th at 11:30 Pm my wife went to hospital. not being able to breathe sufficiently. This star... Read more
On Apr 7th at 11:30 Pm my wife went to hospital. not being able to breathe sufficiently. This started the day before on the 6th while out walking. She is in the hospital being treated for embolisms of the lungs on both sides with multiple blood clots.
74 2021-04-07 pulmonary embolism Patient presented to ER with R back pain paresthesia. CTA performed:Segmental and subsegmental pulm... Read more
Patient presented to ER with R back pain paresthesia. CTA performed:Segmental and subsegmental pulmonary emboli involving the left upper lobe.
74 2021-04-07 chest pain, cardiac arrest Patient was vaccinated on 4/6/21 at 9:05 am. Report received that patient was in the car on the way... Read more
Patient was vaccinated on 4/6/21 at 9:05 am. Report received that patient was in the car on the way home from the vaccination and had chest pain and shortness of breath. Patient called their primary care doctor who requested reporting to the nearest emergency room immediately. Patient became unresponsive in the car. Patient arrived in cardiac arrest (arrival time noted to be 4/6/21 at 10:54 am, CPR began. Patient was intubated in the ER, and received epinephrine, amiodarone, and was defibrillated several times per ACLS protocol. Patient did not have return of spontaneous circulation and was subsequently pronounced. Per report, it was noted that patient was short of breath prior to receiving vaccination earlier in the day.
74 2021-04-09 nosebleed After two days: severe nose bleed. After eight days: vomited blood; followed by endoscopy to fix ... Read more
After two days: severe nose bleed. After eight days: vomited blood; followed by endoscopy to fix stomach bleed. After 17 days days, lung hemorrhage.
74 2021-04-09 chest discomfort February 17, 2021: Patient received 1st dose of PfizerBioNTech vaccine. Reported mild cough, nause... Read more
February 17, 2021: Patient received 1st dose of PfizerBioNTech vaccine. Reported mild cough, nausea and bone pain lasting one week. However, she felt it wasn't severe enough to contact me as her asthma specialist. No cough per patient for the week prior to the second dose of PfizerBioNTech. March 10, 2021: Patient received 2nd dose of PfizerBioNTech vaccine at 1:10pm. Said she had mild chest tightness during the waiting period and used her Ventolin but she attributed it to the characteristics of the waiting room area. Between 5:00pm and 6:00pm (~4 hours later), she became light-headed, vomited and began to cough frequently. She contacted her primary care physician who told her to use Mucinex and contact me if needed. March 12, 2021: Patient contacted my office in the early afternoon. Unable to stop coughing while on telephone. Came to office approximately 90 minutes later. Physical Exam; Peak Flow 210 (personal best 310-320), oxygen saturation 93-95% (typically 97-98%), temp-98.2 F. Intractable cough with scattered bilateral expiratory wheezes on auscultation. Heart rate 132 and regular. Patient treated with Levalbuterol 1.25 mg nebulization with subsequent modest improvement in frequency of cough, pulse 102, oxygen saturation 96-97%. She declined going to emergency department of hospital because she did not want to get infected with COVID-19 from a patient in the waiting room. She declined Prednisone when told that the corticosteroid might reduce the efficacy of the 2nd dose of the vaccine. Placed on Budesonide 1 mg bid and Levalbuterol 1.25 mg q4-6h prn. March 16th: Patient reported her cough was 70% improved and wanted to stop Budesonide. Patient was told to continue Budesonide daily at 1 mg q day. April 5th: Patient contacted my office because of continued coughing and wheezing. Had been hospitalized March 25-27 for the cough.
74 2021-04-12 pulmonary embolism Acute pulmonary embolus with mild right heart strain. Woke at 3am on 4-3-21 with severe pain and di... Read more
Acute pulmonary embolus with mild right heart strain. Woke at 3am on 4-3-21 with severe pain and difficulty breathing, went to emergency room and was given a CT scan, diagnosed and treated with Heparin IV. drip and admitted to the hospital. Later an ultrasound test showed another clot in my left leg so I was started on Apixaban (Eliquis) 5 milligram . Released and sent home on 4-5-21
74 2021-04-12 pulmonary embolism Pulmonary embolism
74 2021-04-12 fibrin d dimer increased, low blood oxigenation Two days after receiving vaccine patient and family reports patient developed nausea and headache. s... Read more
Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report.
74 2021-04-13 haemoglobin decreased Patient presented to the hospital for low hemoglobin, hematuria, abdominal pain, and cough. The pati... Read more
Patient presented to the hospital for low hemoglobin, hematuria, abdominal pain, and cough. The patient tested positive for COVID-19 upon admission to the hospital on 3/24/2021. CXR showed mild pulmonary vascular congestion. The patient was on 2L/min supplemental oxygen throughout admission.
74 2021-04-19 skin turning blue, pulmonary embolism, chest discomfort, deep vein blood clot Patient was admiited to the hospital on April 9, 2021 complaining of tightness in her chest was note... Read more
Patient was admiited to the hospital on April 9, 2021 complaining of tightness in her chest was noted to be clammy with blue tinted lips and fingertips. Vital signs were BP 114/72, Pulse 135, Respirations 20, O2 Room air 80% Shortness of breath. While at the hospital she was diagnosed with a saddle embolus of the lungs and also a DVT on her left leg. She was sent back on hospice and is being treated with Eliquis
74 2021-04-24 cerebrovascular accident Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache ... Read more
Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache like migraine/chronic migraine; symptoms of a stroke; weakness on my right side from tongue to nose; weakness on my right side from tongue to nose; extreme nausea; general malaise; My shot arm feel like felt like I had been hit for several days; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) via an unspecified route of administration on 09Feb2021 at age of 74-year-old at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 19Jan2021 at age of 74-year-old for COVID-19 Immunization, the patient had no soreness or reaction until 10days later on 29Jan2021 when she had a low fever ~0.5-1 degree with chills and aches like a fever for 3 days, the patient experienced aches and pain; hurting all over on 29Jan2021, the patient took no medications, there were no further reaction. The second shot given on 09Feb2021, the patient's shot arm felt like she had been hit for several days beginning 10Feb2021. On 11Feb2021, the patient got a severe headache like migraine. Pain level 10/10. She had chronic migraine with all symptoms of a stroke (extreme nausea and weakness on her right side from tongue to nose, extreme headache about left side of the head). The headache on 11Feb2021 was overlap headache. On both sides of head and nausea. No other migraine symptoms. It lasted for 3 days. The patient was hospitalized due to the event(s) headache like my head was going to explode/severe headache like migraine/ chronic migraine. The patient took only butalbital, caffeine, paracetamol (FIORICET, 50, 325-40) from 11Feb2021 to 12Feb2021 at 40mg caff for several headache like migraine; promethazine (PHENERGAN) from 11Feb2021 to 12Feb2021 at 25mg for several nausea. The patient had several events general malaise where she didnot feel like doing her thing until today 30Mar2021. She had taken no medications or seen a doctor about it. The outcome of "headache like my head was going to explode/severe headache like migraine/pain level 10/10", "headache like migraine/chronic migraine" was recovered in 2021. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021145090 same patient, same drug, different event, different dose separated in times
74 2021-04-24 hypertension Hypertension 226/136; Felt dizzy; Sick; This is a spontaneous report from a contactable consumer (pa... Read more
Hypertension 226/136; Felt dizzy; Sick; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 07Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Two days after dose 1 of BNT162B2 (09Jan2021) the patient experienced hypertension, felt dizzy, and sick. The patient had not experienced dizziness and hypertension before. She decided not to receive dose 2 of BNT162B2 and wanted to know if it was too late to receive dose 2. The patient underwent lab tests and procedures which included blood pressure measurement of 226/136. The outcomes of hypertension, felt dizzy, and sick were unknown. No follow-up attempts are possible. Information about lot/batch cannot be obtained.
74 2021-04-24 fainting, loss of consciousness I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chill... Read more
I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 12:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included Thyroidectomy. Concomitant medications included pravastatin sodium (PRAVASTATIN SODIUM); levothyroxine sodium (SYNTHROID); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient received first dose of BNT162B2 on 27Feb2021 at 74-years-old for COVID-19 immunization: lot number=EN6203, lot unknown=False, administration date=27Feb2021, vaccine location=Left arm, dose number=1. On 22Mar2021 16:00, the patient fainted and hit her head. On 21Mar2021, the patient had stomach cramps, diarrhea and chills. I was wondering if passing out was an uncommon side effect. The outcome of the events was recovered. The patient received treatment for the events.
74 2021-04-24 transient ischaemic attack TIAs; Face, from the nose down looked like teeth were melting; so disoriented, she didn't know where... Read more
TIAs; Face, from the nose down looked like teeth were melting; so disoriented, she didn't know where she was, she didn't feel like herself; since this happened she makes mistakes; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the upper right arm on 06Mar2021 at 17:30 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus diagnosed in 1998-1999, high blood pressure diagnosed about 3 years later from Diabetes Type 2, like 2002 and little bit obesity. The patient family medical history included that her mother passed in 2008 and was admitted to hospital where she had TIA maybe in 2005. The patient's concomitant medications were not reported. The patient was not administered additional vaccine on same date as suspect vaccine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient family medical history included that her mother passed in 2008 and was admitted to hospital where she had TIA maybe in 2005. On 19Mar2021, the patient woke up so disoriented, she didn't know where she was, she didn't feel like herself, felt weird. She was staring out the window, and she daughter called her on the phone and caller told daughter she was feeling crazy, that morning was feeling weird and her daughter informed it was not morning it was in the evening and patient did not sound right. The patient's face from the nose down, looked like her teeth were melting, both cheeks looked like they were melting. She said her bottom lip was turned out and down, sagging, drooping. On 19Mar2021, about 18:30, the patient went to emergency room and was admitted to the hospital on 19Mar2021 around 21:00-22:00. On 19Mar2021 around 21:00-11:00, while she was in the hospital, her sugar had gone up to 310, hard time bringing her sugar down and blood pressure was way up, way higher than normal. In the hospital the patient was told she had transient ischaemic attack (TIA). The patient was discharged on 21Mar2021. The patient informed that since it happened she was making mistakes. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EP6955) via an unspecified route of administration in the upper right arm on 27Mar2021 as single dose for COVID-19 immunization. The informed that the she waited until after she received her second dose to inform about the events just in case something else happened. She stated she was fine now, everything was ok and stated she did believe the events were related to the vaccine. The patient followed up with her primary doctor, talked to him about her experience and going into the hospital. He instructed her to call Pfizer and let them know of her experiences. The patient underwent lab tests and procedures which included Computerised tomogram scan, Magnetic resonance imaging on unspecified date in Mar2021 and sugar 310 and hard to bring down, blood pressure was way up on 19Mar2021. The outcome of event since it happened she made mistake was unknown and rest all events was recovered on an unspecified date 2021.
74 2021-04-25 cardiac arrest Witnessed sudden cardiac arrest
74 2021-04-26 chest pain, ischemic chest pain chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness... Read more
chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness to my heart; She also had tenderness in muscle where site of vaccine was; headache; Left arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation (Age at vaccination 74 years) . Medical history included atrial fibrillation from 2019 (AFib was diagnosed a couple of months before Dec2019) , chronic obstructive pulmonary disease from Dec2019 , medical device implantation (Watchman device inserted), anaemia , oesophagogastroduodenoscopy , oesophageal stenosis, obesity. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) from Jul2019 to an unspecified stop date; metoprolol (METOPROLOL) taken for heart rate irregular from Nov2019 to an unspecified stop date. The patient previously took bnt162b2 for covid-19 immunisation on 06Jan2021. The patient also took aspirin (E.C.) and experienced haemorrhage. The patient experienced feeling occasional pain and tightness to my heart on 30Jan2021 with outcome of not recovered , chest pain on an unspecified date with outcome of not recovered , she also had tenderness in muscle where site of vaccine was on 28Jan2021 with outcome of recovering , headache on 28Jan2021 with outcome of recovering , left arm pain on 28Jan2021 with outcome of recovered. No follow-up attempts are possible. No further information is expected.
74 2021-04-26 troponin increased, fainting troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her h... Read more
troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her head and her back; Chills; fever; She was shaking badly; Fainted; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 11:15 (Lot Number: ER8727; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 74 years). Medical history included ongoing rheumatoid arthritis, melanoma, depression, heart attack (had a heart attack 7 or 8 years ago) and covid (covid in the first week of January). Concomitant medications included levothyroxine sodium (SYNTHROID) and escitalopram oxalate (LEXAPRO) for depression. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for covid-19 immunisation and experienced rash with itching and a lump and swelling (74 years). The patient fainted on 24Mar2021, chills and fever on 24Mar2021 20:00, pain on the back of her head and her back and a couple of places like anyone would get when they fall on 25Mar2021 and she was shaking badly on 24Mar2021. The patient underwent lab tests and procedures which included blood work: unknown results and troponin: high troponin levels on an unspecified date. Therapeutic measures were taken as a result of tremor included Aleve. Outcome of the events chills and pyrexia was recovered on 25Mar2021 (four hours) while outcome of the events head pain and back pain was recovering. Outcome of the remaining events was unknown.
74 2021-04-27 cardiac arrest post-cardiac arrest; collapsed; initial rhythm was PEA; unresponsive; This is a spontaneous report r... Read more
post-cardiac arrest; collapsed; initial rhythm was PEA; unresponsive; This is a spontaneous report received from a contactable pharmacist. A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 20Apr2021 (at the age of 74-year-old) at single dose for COVID-19 immunisation. It was reported that patient was not pregnant. Facility type vaccine was reported as unknown. The patient's medical history included acute respiratory failure with hypoxia, cardiac arrest, transaminitis, and diabetes. It was unknown if patient had COVID prior vaccination. The patient's concomitant medications were not reported. It was unknown if patient received other medications in two weeks and if she received any other vaccine in four weeks. The patient previously received first dose of BNT162B2 on unspecified date at single dose for COVID-19 immunisation, lisinopril and hydrochlorothiazide/triamterene (DYAZIDE) both reported as known allergies. It was reported that patient was brought in by emergency medical services (EMS) status post-cardiac arrest. Per EMS she was driving to urgent care (unclear why). She just got her second Pfizer vaccine. At urgent care she collapsed and cardiopulmonary resuscitation (CPR) was initiated immediately. EMS arrived and her initial rhythm was pulseless electrical activity (PEA). They placed a gel and administered 3 rounds of CPR with 3 onset epinephrine. No shockable rhythm. Patient arrived at hospital intubated and unresponsive on 20Apr2021. Duration of hospitalization was reported as two days. The events were reported as serious with criteria hospitalization and life-threatening illness (immediate risk of death from the event). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if patient was tested for COVID post-vaccination. The outcome of the events was resolving Information on lot number/batch number has been requested.; Sender's Comments: The reported events would seem unlikely related to suspect vaccine BNT162B2, but more likely due to underlying cardiovascular morbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
74 2021-04-30 chest pain She feels she has a cold in her chest; cold; influenza A; Hacking cough; voice affected; chest burni... Read more
She feels she has a cold in her chest; cold; influenza A; Hacking cough; voice affected; chest burning; Difficulty breathing; chest congestion; This is a spontaneous report from a contactable consumer. This 74-year-old female consumer reported that she started to receive the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9266) via an unspecified route of administration in arm left on 03Mar2021 08:45AM (at the age of 74-year-old) at single dose for COVID-19 immunisation. First dose of BNT162b2 (Lot number GM or EM9809) was taken on 10Feb2021 (at the age of 74-year-old) in left arm (way up high on the shoulder) for COVID-19 immunisation. Relevant medical history included bronchitis, chronic obstructive pulmonary disease (due to environmental toxins), allergy to different dyes (allergic to yellow, purple, and blue dye) and allergy to medications. The patient has never been a drinker or smoker. Concomitant medications were not reported. A week or so after the second dose, she thought she was having a cold. It has affected her voice and breathing. She thought she had bronchitis. She was going to her doctor on 04May2021. She had a hacking cough and she doesn't know what she has if it isn't a cold. She wondered if it was connected to the vaccine or is it bronchitis. The more she talks the more difficulty in her chest. She was prescribed Robitussin DM cough syrup by her doctor and was taking honey lemon cough drops. She also had congestion in her chest ever since. She has been having like a cold in her chest. It was heard how she was sounding. She never thought it was connected to the vaccine and never expected this to last for this long. The patient asked whether it could be a residual side effects of the vaccine and questioned if this could have had any effect on the COPD. She stated she was not having any problems with it and she has had it for years. Her cough has been the same, she takes a dose of DM cough syrup or a cough drop during the day. Robitussin was working. She was drinking lots of fluids, between 74-96 ounces of water per day. The doctor told her she had A influenza, but she thought she had COVID because she had all the symptoms, but they said A influenza and treated her for influenza A. That morning she had difficulty breathing like bronchitis, her chest was burning inside and was always like that, her talking aggravates everything and she had deep breathing. Her physician said her chest was clear after she thought she had bronchitis at her previous visit. She does not have any questions, she was calling to report an event, she is calling her doctor for further guidance. Cough, difficulty breathing, voice changed required a visit at physician office. Onset date for hacking cough, voice affected, chest burning, difficulty breathing and chest congestion was 10mar2021, while onset date for the other events was unknown. Hacking cough, voice affected, chest burning, difficulty breathing and chest congestion were not resolved, outcome of the other events was unknown.
74 2021-05-04 hypertension, blood pressure fluctuation the blood pressure went up to 220/110; the blood pressure was going up and down; This is a spontaneo... Read more
the blood pressure went up to 220/110; the blood pressure was going up and down; This is a spontaneous report from a contactable consumer, the patient. This 74-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in right arm on 01Apr2021 12:30 (at the age of 74-year-old) as single dose for COVID-19 immunization. There was no relevant medical history was reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within 2 weeks of vaccination. On 01Apr2021 around 20:00, the patient's blood pressure went up to 220/110. Since then the blood pressure was going up and down, she had been to an emergency room (ER) 3 times and was hospitalized for one day. Her doctor prescribed 3 blood pressure medications, but the blood pressure is still not under control. The patient stated that she never had these issues before. On 08Apr2021, post vaccination SARS-CoV-2 test via Nasal Swab was negative. This upcoming Saturday (24Apr2021) is supposed to be her second vaccine, but with this blood pressure she cannot take it and her doctor recommends delaying it. The clinical outcomes of the "blood pressure went up to 220/110" and "the blood pressure was going up and down" were not resolved.
74 2021-05-07 hypertension Blood pressure high/ Her blood pressure got high, the bottom number (diastolic) got up to 101. The h... Read more
Blood pressure high/ Her blood pressure got high, the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158; head congestion/pressure; head congestion/pressure; Headache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiry Date of COVID-19 Vaccine: unknown), via intramuscular in left arm on 01Feb2021 15:30 as single dose for covid-19 immunisation. Medical history included cancer from Nov2017, Verbatim was reported as cancer, she explains she started chemo in late Jan2018 and ran through that year. Starting in Aug2018, she had radiation every day, Intestinal cellulitis, this was diagnosed about 8 years ago; kidney problem and blood pressure. Concomitant medications included simvastatin 40 mg, tablet via mouth at once a day at night taken for blood pressure, start and stop date were not reported, caller verifies it was through insurance and is dispensed in a pharmacy bottle. lisinopril dihydrate 10 mg, tablet via mouth once a day before she goes to bed taken for blood pressure, start and stop date were not reported, it was dispensed in a pharmacy bottle. On 02Feb2021, the patient experienced headache; on an unknown date experienced blood pressure high/ her blood pressure got high, the bottom number (diastolic) got up to 101. the highest the top number (systolic) got was 158, head congestion/pressure. The report received as, caller received her COVID-19 shot on 01Feb2021. She is recorded to get the next vaccine on 19Feb2021. However, she read to not get the second vaccine before 21 days. She had trouble with first shot and is worried about getting in early. The caller confirms she received the vaccine on Monday, 01Feb2021.The caller states right at first while receiving the COVID-19 vaccine, she felt it go into her body. She clarifies further she felt it inside her. She could feel it. That didn't bother her or anything. She may have gotten a slight headache that night, but she had a worse headache the next day. The next day, Tuesday, 02Feb2021, she had a headache for most of the day. She was congested in the head. She wasn't normally congested in the head or have like pressure, the vaccine made her have it. She took Mucinex, but that didn't relieve her headache. She took Tylenol and that helped for a while. Caller provides the following product information for the Mucinex and Tylenol she took. Caller states she is sure the Mucinex (Lot: W000597049, Expiry date: Nov2014) was old because she doesn't take it very often. The caller clarifies she doesn't have Tylenol (Lot# 4HE16818, Expiry date: May2017), she actually has the Acetaminophen (Pain Reliever/Fever Reducer). What she was most worried about was what happened around Wednesday. She clarifies it wasn't the day after receiving the vaccine, it was the next day- Wednesday, Thursday, and Friday. Her blood pressure got high, the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158. Having that bottom number at 101 was kind of scary. She was on blood pressure medicine and her daughter was going to take her to the hospital, but she went ahead and took her blood pressure earlier than what she would normally take it. The blood pressure medicine brought her blood pressure down within a half an hour. When probed for the outcome of her blood pressure, she explains she hasn't taken her blood pressure in the last day or two but she can tell when her blood pressure was high so she doesn't go through the trouble of taking it when it was not. She verifies she has recovered completely from the high blood pressure. Caller confirms she didn't go ahead and go anywhere. It was years and years, she doesn't take flu shot. Caller mentions her husband took the COVID-19 vaccine the same time as her and had no ill effects at all. The patient was not experienced the events in emergency room or physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: high and 158/101 on an unknown date (the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158. Having that bottom number at 101). Therapeutic measures were taken as a result of the events with Mucinex, Tylenol and Acetaminophen (Pain Reliever/Fever Reducer). Outcome of the event Blood pressure high/ Her blood pressure got high, the bottom number (diastolic) got up to 101. The highest the top number (systolic) got was 158 was recovered on an unknown date and for remaining events outcome was unknown. Information on Lot/Batch number has been requested.
74 2021-05-09 platelet count decreased Severe Abdominal pain starting 3/24/21. Went to ER 4/13/21 due to abdominal pain.. Admitted to hos... Read more
Severe Abdominal pain starting 3/24/21. Went to ER 4/13/21 due to abdominal pain.. Admitted to hospital due to very low platelet count of 4,000, Also very low WBC and ANC. While in hospital, received three infusions over three days of platelets. Platelets came up and then dropped. Day 4 and 5 started on high doses of steroids with Gamma globulin infusions both days. Discharged on 4/19/2021. Continued follow-up and care through Cancer care specialists with Dr. Platelets stable but continue in low range. WBC/ANC still critically low. Considered very high risk for infection Receiving Retuximab infusions. Once a week for 4 weeks. Have completed one.
74 2021-05-09 ischaemic stroke This 74 year old female received the Covid shot on 2/20/21 and went to the ED and was admitted o... Read more
This 74 year old female received the Covid shot on 2/20/21 and went to the ED and was admitted on 3/22/21 with the following diagnoses listed below. I63.9 - Cerebral infarction, unspecified I63.9 - Ischemic stroke
74 2021-05-10 low platelet count N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified
75 2021-01-06 hypertension Dizzy, lightheaded, hypertensive
75 2021-01-10 palpitations, blood pressure increased Mild arm soreness at site the following day Significant fatigue on the following five days and now ... Read more
Mild arm soreness at site the following day Significant fatigue on the following five days and now Heart palpitations and elevated BP on day four Mild nausea on day five
75 2021-01-11 chest discomfort Pt returned from parking lot c/o chest tightness
75 2021-01-13 fainting Patient given vaccine. Within 5 minutes husband said she?s having another spasm. She was being moni... Read more
Patient given vaccine. Within 5 minutes husband said she?s having another spasm. She was being monitored for 15 minutes after the injection. After the spasm it appeared to. become a seizure and passed out for 5 minutes . Husband said she missed her medicine and needed her carbidopa/levodopa. 911 arrived and administered oxygen and took to the hospital.
75 2021-01-19 heart rate increased Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbea... Read more
Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbeat and because of her previous history of reaction to chemicals she became anxious. Pt further evaluated by NP and pt c/o itching to back of throat. No SOB. At time of NP evaluation heart rate within normal limit, 84. Alert and oriented. No acute distress. Pt very anxious. Pt monitored for one hour with no issues or emergent care needed.
75 2021-01-20 nosebleed Nose bleed; Dizziness; it left me little weak; This is a spontaneous report from a contactable consu... Read more
Nose bleed; Dizziness; it left me little weak; This is a spontaneous report from a contactable consumer. This 75-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) at single dose for COVID-19 immunization on 09Jan2021. Relevant history included High blood pressure. Relevant concomitant drugs included Losartan for Blood pressure high, and hydrochlorothiazide. The patient had the first Covid 19 Vaccine on 09Jan2021 and she knew little bit dizziness was normal but she had a nose bleed in the next morning that she could hardly stop, she finally got it stopped it, it left she little weak so she just wanted to report that, she did not know if anyone had ever had that before (Hence, MI was made). Outcome of event Nose bleed was recovered, the outcome of other event was unknown.
75 2021-01-21 palpitations Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe B... Read more
Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe BP, but never had that happen before. I was anxious as I have anxiety disorder! But my face was RED and TIRED looking. I asked staff what wrong. No swelling at that time! 4:40 PM. That nite, my heart started POUNDING HARD all night, not stop. Ativan not help. I slept, weird dreams, wake up and still heart pounding. 8 am --- got up and hands, arms, extremities SWOLLEN!! Heart still pounding, Felt like allergic to MSG or nitrates or preservatives or too much salt. Felt weird.. Not faint-- just weird. Tired from the pounding heart. Not fatigued. I did have sore arm, but it was NOT an issue. My hands, toes were red.
75 2021-01-21 chest discomfort On observation after vaccine, patient reported swelling in her mouth and lips. Patient took 2 benad... Read more
On observation after vaccine, patient reported swelling in her mouth and lips. Patient took 2 benadryl 25mg and stated she felt better. Advised patient to go to ER and patient refused. Asked patient to stay for extended observation. About 30 min later, patient stated she was coughing and feeling slight tightness in her chest. At this point, patient was agreeable to go to the ER and patient was taken.
75 2021-01-21 chest discomfort Pts daughter called, pt received Pfizer vaccine on 1/6/2020 and 6 days after pt developed a mild ras... Read more
Pts daughter called, pt received Pfizer vaccine on 1/6/2020 and 6 days after pt developed a mild rash around her mouth. Pt tried Benadryl 25 mg and applied tropical Aquaphor on rash but did not get better. But few days ago the rash had got worst. Pt also feels like there is some kind of swelling and tightness. Per daughter, no white discoloration or puss. The rash is only on the outside of the mouth and not inside. No other symptoms besides the rash (no shortness of breath, dizziness, or difficulty speaking...) Rx Benadryl 25 mg tid and send Prednisone 20 mg od and Famotidine 40 mg od, and Hydrocordozone topical 2-3 times a day
75 2021-01-23 cardiac arrest Cardiac Arrest Acute pulmonary edema
75 2021-01-24 heart rate increased Patient c/o of feeling shaking and pulse racing. Vitals taken 206/93 P98 sao2 98% on RA. at 4:05PM. ... Read more
Patient c/o of feeling shaking and pulse racing. Vitals taken 206/93 P98 sao2 98% on RA. at 4:05PM. 4:06 PM vitals 209/88 P 94 sao2 99%. Pulse increased to 110 at 4:10 PM. Patient transferred to urgent care via w/c. Patient checked and left with nursing staff for evaluation.
75 2021-01-25 heart rate irregular About 10 minutes after receiving vaccine patient became dizzy. BP 112/54, HR range 40-154, irregular... Read more
About 10 minutes after receiving vaccine patient became dizzy. BP 112/54, HR range 40-154, irregular on oscitation. Repeat BP 120/45, HR 105. 02 sat 100%. Patient was sent to the ER for further evaluation and monitoring.
75 2021-01-26 hypotension Progress Notes 1/26/2021 Patient: ... Read more
Progress Notes 1/26/2021 Patient: Date: 1/26/2021 a 75 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience scratchy throat. She denied difficulty breathing, difficulty swallowing and throat tightness. This provider was notified of patient reaction and she was then assessed in the emergency bay area. ALLERGY REVIEW OF SYSTEMS: Patient denies facial swelling, chest tightness, shortness of breath, wheezing and dizziness Previous Reactions: Patient reports a history of previous reaction after receiving an allergy shot many years ago. She is unsure of entire course of events but states she did need medical treatment including a shot. Objective Vitals Vitals: 01/26/21 1412 01/26/21 1439 BP: 135/78 137/63 BP Location: Right arm Patient Position: Sitting Pulse: 90 80 SpO2: 95% 98% Blood Sugar 88 collected at 1415 Physical Exam Vitals signs and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: She is well-developed. She is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Pharynx: Oropharynx is clear. No pharyngeal swelling or oropharyngeal exudate. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No tachypnea or respiratory distress. Breath sounds: Normal breath sounds and air entry. No stridor or decreased air movement. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert and oriented to person, place, and time. Gait: Gait (with cane assist) normal. Psychiatric: Speech: Speech normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy. Patient was observed for 65 minutes s/p injection. She states only symptom of itchy throat improved. Patient accompanied to building exit . Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash)
75 2021-01-27 lightheadedness Dizziness; history included compromised immune status; history included compromised immune status; g... Read more
Dizziness; history included compromised immune status; history included compromised immune status; getting really tired/fatigue; Gets real sweaty; chills; almost passed out at doctor's office; Nausea; Felt cold; Blood in urine; Feeling unwell; Feeling bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686), intramuscular in the left upper arm on 08Jan2021 at 15:45 at 0.3 mL, single for COVID-19 immunization. Medical history included Leighten Plantar Alopecia (hair follicle is an enemy), skin infection (infection in body most of the time, at least on skin), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity, autoimmune disorder (diagnosed 8 months ago). She has lost some height, prior to taking the vaccine and she said it was related to age. There were no concomitant medications. The patient experienced feeling unwell on 10Jan2021; blood in urine on 10Jan2021 at 17:00; nausea at 10:00, chills at 11:00, almost passed out at doctor's office at 10:00, felt cold - all on 11Jan2021; getting really tired/fatigue on 14Jan2021 at 09:30; gets really sweaty on 13Jan2021 at 10:00; and dizziness on unknown date. The patient had the first shot on Friday (08Jan2021). On Sunday (10Jan2021), she started feeling bad. She was feeling good about getting it and had no reaction. She has an autoimmune disorder that made her a little afraid to take, but with all the indications, they said it would be much better for her to take it than to get the COVID virus. Sunday (10Jan2021), she does not feel good. So, she started having blood in urine. She thought she had a UTI and had not had one in 20 years. It felt like that is what she had and with the blood in urine. She just took Tylenol and waited until Monday morning because she does not like sitting in doctor's office. They gave her a cup to give sample and said she didn't need to see provider. They will have it checked and in the meantime call in a prescription. It kept getting worse and worse. She was about to passed out in the doctor's office on 11Jan2021, she got nauseous and almost threw up. She got in the car with her husband and he was trying to get her home. She got chills and got so cold and could not warm her body up. Her husband gave her Phenergan and it kind of knocked her out for a while to ease her nausea. She was thinking of going later today (14Jan2021), when she gets enough energy, to get a COVID test. She does not know if it will give false positive or not. She had chills and now she gets sweaty since 13Jan2021. She took her temperature and she did not have one. She just now got up. It is 10:00. She got up this morning (14Jan2021) and was really tired. She was not sweating this morning. Tiredness is kind of new, and when she talked to the nurse, she sort of felt like maybe it was a reaction to the COVID vaccine, but then she talked to her daughter and she said the symptoms she was having are usually symptoms that occur with second dose of the vaccine. It is not uncommon for people to have symptoms she was having. She wanted to know if she should have a COVID test. If she has had just one shot, would the test give a false positive coming from the COVID. They were asking if patient should take the second dose, and should she continue her UTI medication. Doctor's visit to give urine sample on 11Jan2021 (results: negative for UTI). She did not see a doctor though. They sent sample and prescribed a sulfa based medication for a UTI. She did start feeling a little better and stopped having blood in her urine. She plans to continue it because she does not like to stop taking an antibiotic. She did not have any clue that it was not a UTI until the nurse from her provider's office called to tell her results of urine sample was negative. Outcome of event getting really tired/fatigue was not recovered; events almost passed out at doctor's office, blood in urine, chills, and gets really sweaty was recovering; and unknown for other events.
75 2021-01-28 chest pain Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chil... Read more
Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chills for 3 nights fever range from 100 degrees up to 103.8, had nauseau and vomited one day, my face- looked a little swollen and cheeks were pink, was in bed mostly for 13 days. Called My Doctor after about 4 days , he prescribed MethyIIPredisolone 4 mg tablets, seems to bring fever down and stop chills, still feeling really bad, went to Urgent Care and they did Covid Test which was Negative, had virtual call with their doctor , and they prescribed a "Z Pak" Did not stated feeling better until 13 day. When taking Predisone, I started having chest pains, when I only had 4 more pills to take. Had to take 2 Nitro and discontinued Predisone. Still weak and tired.
75 2021-01-28 heart rate increased Very painful stiff neck; Very painful stiff neck; rapid heartbeat; This is a spontaneous report from... Read more
Very painful stiff neck; Very painful stiff neck; rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021 13:15 at single dose (left arm) for COVID-19 immunization. The patient had no medical history. The patient had no known allergies and patient was not pregnant. Concomitant medication included gabapentin, diltiazem hydrochloride (DILT-XR), losartan and ezetimibe (ZETIA). On 14Jan2021 at 22:00, the patient experienced very painful stiff neck and rapid heartbeat. The patient had no therapy for the events. The patient had no other vaccine in 4 weeks, and did not have Covid prior vaccination. The patient was no Covid tested post vaccination. Outcome of events was not recovered. Information on Lot/Batch has been requested.
75 2021-01-30 heart rate increased fast heartbeat, itchy throat, vomiting
75 2021-02-01 chest discomfort Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and ... Read more
Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and focus) , GI Increase in bowel movements, general malaise. These symptoms have lasted 6 days so far at varying intensity The lung tightness occurred on day 1 and day 4. The nausea has been persistent. The headache was on day 1 and 3. Foggy brain on day 2 and 5. Fatigue everyday. I am concerned about getting the second shot
75 2021-02-01 heart rate increased, atrial fibrillation Pfizer-BioNTech COVID-19 Vaccine EUA. 1.5 hours after receiving vaccine (12pm), I felt a flush/war... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. 1.5 hours after receiving vaccine (12pm), I felt a flush/warm sensation in my heart area. My heart rate increased, jumping around a lot. I could see my chest moving up & down. I tried to monitor BP & heart rate w/my heart monitor. BP was up to 154/103, pulse 73 at 12:20; BP 150/92, pulse 70 at 1:00pm. My normal pulse is 50-55. Twice the monitor read ERROR. By 1:30 BP was 128/75, pulse 61 and I felt heart was more calm. By 10:30pm BP was normal, 116/74, pulse 52. By chance I had appointment with my cardiologist the next day, 1/25/2021. He said it was an episode of atrial fibrillation. I have not had that rapid heart rate issue since the stent implant in December 2011.
75 2021-02-02 arrhythmia, cardiac arrest Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures... Read more
Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest.
75 2021-02-03 chest discomfort Doctors reporting the patient developed rapid, shallow breathing with chest heaviness. Patient had f... Read more
Doctors reporting the patient developed rapid, shallow breathing with chest heaviness. Patient had facial flushing with a blood pressure reportedly at 212/90. However, a second opinion from another doctor stated they were unsure if true anaphylaxis. Epi pen was administered LOT 0FM498 and patient left in ambulance to go to ER.
75 2021-02-03 transient ischaemic attack Sudden onset of left arm heaviness and problems working 3rd and 5th digits of left hand. Admitted ov... Read more
Sudden onset of left arm heaviness and problems working 3rd and 5th digits of left hand. Admitted overnight for suspected TIA. MRI subsequently confirmed acute to subacute right frontoparietal infarct
75 2021-02-03 fainting T.C. from sister to communicate the hospitalization of her sister. She reported that on Friday patie... Read more
T.C. from sister to communicate the hospitalization of her sister. She reported that on Friday patient collapsed and started foaming at the mouth and was rushed to hospital. She stated that patient is on a ventilator and at 5PM today they are going to take her off. Sister was very upset and I was uncomfortable asking more questions. She will call me with more information at a later time. She did say that the hospital staff was not sure of what caused her collapse.
75 2021-02-04 ischemic chest pain severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tirednes... Read more
severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a "D", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a "B" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.
75 2021-02-05 loss of consciousness I woke up feeling sick with headache and pain in abdomen, went to bathroom and sat down, I was burni... Read more
I woke up feeling sick with headache and pain in abdomen, went to bathroom and sat down, I was burning up and perspiration was dripping down my body, i felt like i might throw up and that was the last though until I came to on the floor of our walk in shower. It took me a while to orient myself and get up and sat down again on toilet still with pain in head and disoriented. next thing i know i am coming to wedged between the toilet tank and the vanity. I managed to get back on the toilet and sat there wondering what was happening to me. I could tell i was getting better so i just sat there a while longer until i though my legs would hold me so i could get back to the bed. I laid in bed the rest of the night unable to sleep with headache and shivering with being cold even under my blankets. I stayed in bed Saturday then called the doctor first thing Monday morning. I got in to see her at 10:30 Monday morning. She ordered a full blood panel and urinalysis and heart monitor for 48 hours. The blood panel and urinalysis reports are all ok. Have not received report yet from the heart monitor. Doc said I cannot take the second shot.
75 2021-02-06 hypertension Extremely high blood pressure. On 2/5 started 192/82 at 6 PM , first time I checked it on 2/5. Cont... Read more
Extremely high blood pressure. On 2/5 started 192/82 at 6 PM , first time I checked it on 2/5. Continued up to 216/84 at 11 PM. Called 911.. EMT did EKG which looked OK. Pressure dropped 20 points in 30 minutes. No other symptoms , no pain , no nausea , no fever. Did not go to hospital. 2/6 , had 3 readings , 174/79 , 150/75 and last one at 9 PM , 165/73 . On 2/7 , 1 reading at 2 PM , 142/74. No other symptoms.
75 2021-02-07 chest discomfort, chest pain Pt was driving home from vaccination and she had a sharp left sided chest pain. She pulled over and... Read more
Pt was driving home from vaccination and she had a sharp left sided chest pain. She pulled over and resolved but has had intermittent left sides chest pain/pressure since. On Monday 2/8 she was directed to go to the ED for evaluation.
75 2021-02-07 low blood oxigenation Went to ER on 2/5 with Shortness of breath and productive cough since first vaccine given. Diagnosed... Read more
Went to ER on 2/5 with Shortness of breath and productive cough since first vaccine given. Diagnosed with hypoxemia, and COVID pneumonia. Admitted to hospital
75 2021-02-07 inflammation of the pericardium, chest pain accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; ... Read more
accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit. Information on the lot/batch number has been requested.
75 2021-02-08 inflammation of the pericardium Acute pericarditis complicated by atrial flutter
75 2021-02-08 hypertension Numbness in lower extremities, not able to walk independently, headaches, dizziness, hypertensive, s... Read more
Numbness in lower extremities, not able to walk independently, headaches, dizziness, hypertensive, sleeping 16+hours a day, and poor to no reflexes.
75 2021-02-08 cerebrovascular accident her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke bet... Read more
her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke between 4 and 6pm. She died within 6 to 7 hours later.
75 2021-02-09 fainting, chest discomfort 75-year-old woman who presented to the emergency room 2 days after vaccination with chest tightness,... Read more
75-year-old woman who presented to the emergency room 2 days after vaccination with chest tightness, fatigue and was found to have pericardial effusion without tamponade. It was noted that patient has had intermittent syncope since August of 2020 and clinical interpretation is likely that pericardial effusion pre dated vaccination. In her workup for dizziness and syncope she had not previously undergone EKG, chest x-ray or echocardiogram therefore pericardial effusion could have been missed. I elected to report the pericardial effusion to be on the side of caution.
75 2021-02-10 heart rate increased, hypertension On day 2 I had a low grade fever On day 10: High blood pressure 205/77 for over an hour. ... Read more
On day 2 I had a low grade fever On day 10: High blood pressure 205/77 for over an hour. Difficulty breathing; A fast heartbeat(90); Dizziness; Chills; Uncontrollable shaking for over an hour. Rash on face for less than an hour Starting on day 11: Blood pressure gradually reduced to my normal level over days Headache continued for several days
75 2021-02-10 cardiac arrest PATIENT ARRIVED TO ED ON 2/9 IN FULL CARDIAC ARREST
75 2021-02-10 chest pain, blood pressure increased tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not i... Read more
tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not in her throat but it was on her neck behind her ear; blood pressure spiked; tired; she didn't sleep well; Chest pain; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: lot number: E19262, via an unspecified route of administration, left arm, on 26Jan2021 10:00 at a single dose to not get Covid and to protect others around her. Medical history included mini stroke at least 8-10 years ago and neuropathy in face from ministroke. Concomitant medication included gabapentin for neuropathy in face from ministroke. The patient had no prior vaccinations (within 4 weeks). The patient previously took pregabalin (LYRICA): but was changed to gabapentin. On 26Jan2021, the patient experienced tingling of lip and face, numbness on left side of face, blood pressure spiked and chest pain. On 27Jan2021, the patient experienced tired. The events were described as: After getting the vaccine, she experienced tingling of the lip and left side of her face. She had numbness on the left side of her face. The numbness was not in her throat but it was on her neck behind her ear. Her blood pressure spiked. She drover herself to the emergency room. Her blood pressure was 160 something over 101. She was unable to specify the exact number. Then her blood pressure decreased to 104 over 80 something and it increased to 202 systolic. She was unable to specify the reading. She was tired on 27Jan2021 because she didn't sleep well in the hospital. She signed out against medical advice. The patient had a full work up to include a CT scan, MRI and doppler: results were not provided (unknown results). The patient wanted to know if recommendations were made in regard to taking the second dose if they have had adverse events. The patient was hospitalized from 26Jan2021 to 27Jan2021 (1 day) for tingling of lip and face, numbness on left side of face and blood pressure spiked. Chest pain was considered medically significant by the reporter. The outcome of she didn't sleep well was unknown. The patient was recovering from tingling of lip and face and tired. The patient has not recovered from numbness on left side of face. The patient recovered from blood pressure spiked and chest pain on 27Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
75 2021-02-11 excessive bleeding, fainting Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next... Read more
Jan 18 COVID vaccine usf 11:30 am pfizer vaccine first dose, starting feeling bad: headache the next day had class collapsed and stubbed toe, bleeding etc. ambulance came and assessed, PT felt so weak could not stand but was declared ok to drive by emt, got home and collapsed on the floor and crawled around for 6 days, lived on boiled eggs and rice cakes, doctor said call an ambulance, ambulance picked her up and took her to hospital, hospital took care of her for 16 days, got discharged yesterday (2-9-2021)
75 2021-02-11 fast heart rate, hypertension PT C/O BURNING FROM CHEST UP, TACHYCARDIC, AND HYPERTENSIVE. SENSATION RELIEVED W/ BENEDRYL
75 2021-02-14 palpitations patient became flushed, lightheaded and felt rapid heart rate 15 minutes after receiving vaccine. no... Read more
patient became flushed, lightheaded and felt rapid heart rate 15 minutes after receiving vaccine. no shortness of breath, no rash or hives.
75 2021-02-15 cardiac arrest What I know so far is they gave her the shot her heart stopped for about 3-4 minutes they did cpr un... Read more
What I know so far is they gave her the shot her heart stopped for about 3-4 minutes they did cpr until the ambulance got there they took her to main. They are going to do a bunch of test . They are going to keep her she has too see the cardiologist they are going to do an eco cartogram and an ultrasound of her heart. They had to my mom on a ventilator because they where putting the defibrillator in and she started throwing up and they had to do compression again cause her heart stopped again and she stopped breathing
75 2021-02-17 hypertension Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue... Read more
Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; headache; high bp/ had a BP 173/113; short of breath; couldn't sleep; restless; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Ten minutes after she reported having a headache, which she ignored. 2 hours later, very high blood pressure (BP), short of breath (SOB) and restless occurred. All night on 25Jan2021 and the next day on 26Jan2021, the patient couldn't sleep, short of breath, restless. The patient called PCP and was told to go to the ER. She did and had a BP 173/113, SOB. She was admitted, CT scan was ok. She had very bad rash blue red swollen on thigh. Heart enzymes was normal. She was discharged two days later referral to a dermatologist. The outcome of events was unknown. Information on the batch number has been requested.
75 2021-02-18 oxygen saturation decreased Admitted with covid pneumonia, Acute hypoxic respiratory failure, currently in ICU ventilator depend... Read more
Admitted with covid pneumonia, Acute hypoxic respiratory failure, currently in ICU ventilator dependent respiratory failure. Patient tested 1/26 with 1/29 positive results. never symptomatic. presented to receive covid vaccine and received it on 2/1, ( reportedly discussed with a physician to make sure getting vaccine was ok) Then hospitalized 2/11 with urosepsis and discharged 2/14. 2/15 presented to oncology office with o2 sats 78% on RA. transported to Hospital.
75 2021-02-18 palpitations Palpitations, flushing, sweating. BP 190/120 (pulse 119), 210/88, 175/88. Sent to ED and cancelled s... Read more
Palpitations, flushing, sweating. BP 190/120 (pulse 119), 210/88, 175/88. Sent to ED and cancelled second vaccine dose.
75 2021-02-18 heart rate increased, atrial fibrillation Rapid heart rate, atrial fibrillation episode after both first and second dose. I have occasional/r... Read more
Rapid heart rate, atrial fibrillation episode after both first and second dose. I have occasional/rare atrial fibrillation. This episode was directly after each dose. Heart rate elevated to 140 bpm; Rapid heart rate, atrial fibrillation episode after both first and second dose. I have occasional/rare atrial fibrillation. This episode was directly after each dose. Heart rate elevated to 140 bpm; This is a spontaneous report from a contactable pharmacist (patient). A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 16:30 (the first dose, lot number: EL3249) at single dose; via an unspecified route of administration on 03Feb2021 (the second dose, lot number: EL9264) at single dose, both in left arm for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM) and the patient had myectomy surgery for Hypertrophic Obstruction Cardiomyopathy in 1993. Concomitant medications included paracetamol (TYLENOL), verapamil hcl, simvastatin, apixaban (ELIQUIS). No covid prior vaccination and no covid tested post vaccination. The patient had no known allergies. The patient had rapid heart rate, atrial fibrillation episode after both first and second dose. The patient had occasional/rare atrial fibrillation. This episode was directly after each dose. Heart rate elevated to 140 bpm, lasting 12 hours after 1st dose, 17 hours after 2nd dose. The patient underwent lab tests and procedures which included heart rate was elevated to 140 bpm in Jan2021 and Feb2021. No treatment was received. The outcome of the events was recovered in Jan2021 after first dose and recovered in Feb2021 after second dose.; Sender's Comments: Based on available information, a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported events Atrial fibrillation and Heart rate high. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
75 2021-02-18 blood pressure increased, palpitations ten minutes after I got the vaccine they had me sit and wait and I got a hot flush on my chest and ... Read more
ten minutes after I got the vaccine they had me sit and wait and I got a hot flush on my chest and neck. I felt dizzy, light headed. my heart was pounding. nurse came and checked my blood pressure it was 186/86. normal BP is 120-130. she took it again 10 minutes later and it was 170. the whole attack lasted about 25 minutes.
75 2021-02-21 blood pressure increased Patient self-reported left arm pain traveling down her arm after second dose of covid vaccine (pfize... Read more
Patient self-reported left arm pain traveling down her arm after second dose of covid vaccine (pfizer) administration. Patient has documented history of anaphylaxis with IV contrast. EMS on-site provided cardiac monitoring. Observed elevated BP.
75 2021-02-21 hypotension She felt hypotensive. She states that she felt that her BP was increasing. Average range is 160/170 ... Read more
She felt hypotensive. She states that she felt that her BP was increasing. Average range is 160/170 systolic. Felt anxious prior to vaccine. Denied SOB, difficulty breathing, denied chest pain or dizziness. 15:35 VS 187/72 and HR 69. 16:17 VS 212/94 HR 71 RR 14 and o2 sat 100%. Brought patient to our express symptom management unit.
75 2021-02-21 transient ischaemic attack TIA 10 days after injection
75 2021-02-22 nosebleed, low blood platelet count, platelet count decreased 1 week of nose bleed, admitted for ITP
75 2021-02-23 chest pain, blood pressure increased Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of a... Read more
Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (lot number: EL9262), via an unspecified route of administration, at arm left, on Jan2021 at single dose for COVID-19 immunisation. Medical history included Prediabetes from 2019 (reported as diagnosed two years ago), overweight from an unknown date, ongoing arthritis from 2017 (reported as about 4 years ago), gets worse now. There were no concomitant medications. Caller states she just has a question, states she took the test about 2 weeks ago, clarifies the Pfizer vaccine and due for next one on Sunday, caller wanted to find out if what she experienced could be due to the vaccine, states she had a reaction for almost two weeks (also reported that all the events started on 05Feb2021, pending clarification), states her blood pressure went up, she had chest pain in her chest, weakness, loss of appetite, states it lasted about 24 hours, no exact dates provided. Also experienced Bell's Palsy states it comes and goes, that when she talks the saliva comes down the side of her mouth. States her Blood pressure went really high, 145/90 or so, lasted about 24 hours. Did not know if she was having a heart attack. Does see a cardiologist because of a family history of cardiac issues. The outcome of the event Bell's Palsy was not recovered, of the other events was recovered on Jan2021 (reported as lasted for 24 hours).
75 2021-02-23 chest discomfort Patient complained of lightheadedness with slight disorientation, chest heaviness. Patient transpor... Read more
Patient complained of lightheadedness with slight disorientation, chest heaviness. Patient transported to ER for further evaluation & treatment.
75 2021-02-24 cardiac arrhythmia, palpitations 1 to 2 minutes after injection began having heart palpitations and PVCs. Lasted 1 hour No treatment ... Read more
1 to 2 minutes after injection began having heart palpitations and PVCs. Lasted 1 hour No treatment was required
75 2021-02-24 chest discomfort Pt developed chest tightness approx 10-15 minutes post vaccination. Also c/o HA and dizziness. BP 1... Read more
Pt developed chest tightness approx 10-15 minutes post vaccination. Also c/o HA and dizziness. BP 138/63 HR 66 SpO2 98% RA Pt brought to ER
75 2021-02-24 hypertension Within 15-minutes of vaccination, the patient reported difficulty swallowing, No difficulty breathin... Read more
Within 15-minutes of vaccination, the patient reported difficulty swallowing, No difficulty breathing, pain, or other complaints voiced. EMS evaluated the patient on-site. The patient was hypertensive (208/103). EMS noted that the patient was visibly anxious and that they elected to be transported to Emergency Department for evaluation. When contacted for medical records, ED stated that the patient never was checked into the hospital and did not have records available. Assumed lost to follow-up.
75 2021-02-25 chest pain, chest discomfort, palpitations Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started hav... Read more
Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started having a sharp chest pain on drive home. She pulled over and the feeling went away. No other symptoms. On sat morning patient started getting twinges of chest pain on left side bottom by her breast. On Saturday night and Sunday morning patient started belching. She doesn't normally have belching. This morning patient felt like her heart racing. She is still having a chest pressure. Was sent to ED 2/8/21 after triage. Labs unremarkable, troponin negative, instructed to f/u with PCP, discharged in stable condition. F/U w/ PCP 2 weeks later and reported weight loss, weakness, possible facial droop (although not noticed today on exam). Symptoms appear to be improved.
75 2021-02-25 chest discomfort Patient was given her second dose of Pfizer COVID vaccine. After 15 minutes patient was C/O difficul... Read more
Patient was given her second dose of Pfizer COVID vaccine. After 15 minutes patient was C/O difficulty breathing. Vital signs B/P:155/77,HR: 90, RR: 22, Breath sounds clear bilaterally, O2 98 room air. Patient continued to experience chest pressure
75 2021-02-25 palpitations racing heart; This is a spontaneous report from a contactable consumer, the patient. This 75 year ol... Read more
racing heart; This is a spontaneous report from a contactable consumer, the patient. This 75 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via an unspecified route of administration in the left arm on 25Jan2021 at 15:00 (at the age of 75 years old) for COVID-19 vaccination. There was no relevant medical history. There were no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021, the patient had a racing heart. The event was reported as non-serious. There was no treatment received for the event. The clinical outcome of racing heart was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
75 2021-02-28 body temperature decreased At 9:30 A.M. on 2/23, I noticed that I had a slight headache. My left arm was, as I had expected, p... Read more
At 9:30 A.M. on 2/23, I noticed that I had a slight headache. My left arm was, as I had expected, painful and red near the injection site. As the day progressed, I became aware of more reactions: chills, body aches, increasing headache, arm pain, and changes in my temperature (I usually have a temperature of 97.6, but measured 96.6 and in the evening, 100.4). I felt listless and nauseous by dinnertime. By the morning of 2/24, nothing was improved, so I took 2 Tylenol, which I repeated 7 hours later and 7 hours after that. By the morning of 2/25, I began feeling better and stopped the Tylenol. My symptoms gradually continued to improve through 2/28.
75 2021-02-28 chest pain hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling ki... Read more
hurting in her chest, like she has to keep breathing; feeling kind of weird/ feeling bad; feeling kind of weird, off balance; Upset stomach; Chills; She cannot function very good, She is feeling so bad and cannot do nothing; At night time it is hard to try to do something and she cannot do it because she is tired; can hardly breathe at night; it kind of feels like she has an ear ache but she does not have an earache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via intramuscular route of administration on 14Jan2021 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) from an unknown date (per patient diagnosed quite a while ago and she goes to a pulmonary doctor). Concomitant medications included unspecified inhaler at two puffs per day if needed and unspecified recue inhaler one puff a day as needed, both ongoing for one year for COPD. The patient did not receive any other vaccines within four weeks prior to the vaccination or any other prior vaccinations or any vaccinations on the same date of the vaccination. The patient experienced chest pain, feeling abnormal, feeling off balance, upset stomach, chills, cannot function very good, tired, can hardly breathe at night and ear discomfort, all in Jan2021. The patient reported she received the vaccination on 14Jan2021 by her primary doctor. She is feeling kind of weird and has an upset stomach. She is asking how long this will last. She is worried about taking the second dose. She is supposed to have the second dose on 04Feb2021. She cannot function very good, states it kind of feels like she has an ear ache but she does not have an earache. Her balance is off and she can hardly breathe at night. All her symptoms started on the third day after getting the shot (Jan2021). She reports the feeling weird and off balance feeling feel like you are drunk. It aggravates her because she cannot function right. She also experienced chills started the third day after the shot and the chills have recovered completely. The patient reported that she was alright the first day. She has hurting in her chest, like she has to keep breathing which also started the third day after getting the shot and has been going on all this time. At night time it is hard to try to do something and she cannot do it because she is tired, states it is the worst part, She is feeling so bad and cannot do nothing. She has a hard time breathing. The events did not require a visit to emergency room or physician office. The patient did not have any relevant tests. The clinical outcomes of the events chest pain, feeling abnormal, feeling off balance, upset stomach were not recovered. The patient recovered from the chills in Jan2021. The outcome of the cannot function very good, she is feeling so bad and cannot do nothing, tired, can hardly breathe at night and ear discomfort was unknown.
75 2021-03-01 heart rate increased, chest discomfort Severe allergic reaction; wheezing; felt right through her chest like through her right side kind of... Read more
Severe allergic reaction; wheezing; felt right through her chest like through her right side kind of going into her left; it was weird like she could feel going into her body/ suddenly felt strange sensation in her chest; heart started beating really fast/ heart started beating very rapidly; face was all red/ face growing red and swelling slightly; face was all red/ face growing red and swelling slightly; breathing was becoming labored; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3248, NDC/UPC number and expiry date were unknown), via an unspecified route of administration in the right arm on 12Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. The vaccine facility type was reported as the "doctor's office/urgent care." Relevant medical history included high blood pressure, but it was controlled blood pressure/hypertension; asthma, for which she was not taking medication at the time of the report, because it was under control; non allergic rhinitis; pre diabetes; and a little overweight. The patient further stated that she had just general medical history, which she had everything under control. Concomitant medications included lisinopril, montelukast sodium (SINGULAIR), atorvastatin (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), and metformin. The patient previously took to iodine, doxycycline, erythromycin, and azithromycin, for which the patient had known allergies to all of it. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. She was not tested for COVID-19 post vaccination. The patient stated that on 12Jan2021 at 10:30, she had adverse reactions to the Pfizer vaccine; she had severe allergic reaction within about 30 minutes and then they call the paramedic she ended up and they gave her a shot, which she did not know if it was prednisone. It was further reported that she took her inhaler too as they said she was wheezing, which she didn't really feel in her lungs. The patient just felt that what happen was she went to the car as they said to wait 15 minutes as written, and she always follow the rules and the whole thing they said, she waited 30 minutes, so she went down side of her car then she figured that she could just drive off drive home. So, she was in car sitting or waiting for the last 30 minutes and all of a sudden she felt right through her chest like through her right side kind of going into her left; it was weird like she could feel going into her body, then suddenly her heart start beating really fast, and then she pulled down the vizor and looked in the rearview mirror and her face was all red, so she go back to the site. That's how she transpired and then, that's how the reaction was. It was further reported that the patient waited 15 minutes in the office, then went to car to wait additional 15 minutes, and suddenly felt strange sensation in her chest and her heart started beating very rapidly. She pulled down the visor in car and saw her face growing red and swelling slightly and her breathing was becoming labored. She had read on side effects on information she was given on departure stating symptoms of an allergic reaction. She returned to the facility at which time she was treated. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. The patient had no investigation assessment. Therapeutic measures were taken as a result of all the events, which included that the patient was given a shot of 125 mg of methylprednisolone sodium succinate (SOLU-MEDROL), but another report said they gave her prednisone so they were kind of conflicting in the report, but it was a shot, and also cetirizine (ZYRTEC) and famotidine (PEPCID), and her inhaler for wheezing. The patient recovered from all the events on an unspecified date.
75 2021-03-01 pallor itching tongue face lips, mild swollen tongue and lips, neck pain, hoarse voice, cough, pale. Pr... Read more
itching tongue face lips, mild swollen tongue and lips, neck pain, hoarse voice, cough, pale. Progressively worse in order listed over 10 minutes. Chewable benadryl 12.5 mg x 4 given. Pt reported improved symptoms within 10 minutes and was asymptomatic at 30 minutes.
75 2021-03-01 coughing up blood, nosebleed thought it was my tooth bleeding because that's what it looked like if you cut yourself; the phlegm... Read more
thought it was my tooth bleeding because that's what it looked like if you cut yourself; the phlegm she spitted up this morning had blood in it; she started to bleed/nose bleed coming out of my mouth; achy; tired; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 28Jan2021 08:05 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included an unspecified sinus disorder, unspecified allergies and reflux usually after eating, all from unknown dates and unknown if ongoing. The patient's historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on 06Jan2021 with no specified side effects. The patient's concomitant medications were reported as unspecified medications for sinus problems and allergies. The patient stated that she got the second dose on "Thursday." She experienced side effects "that everybody has like achy and tired for two days." She continued to say that she normally spits up phlegm in the morning from sleeping overnight because she has sinus issues and she snores. This morning ("Saturday") it was pinched with blood and she was bleeding, just bleeding. She's not bleeding anymore because she has a mouthwash medication to make gargles and also with salty water. She thought it was her tooth bleeding because that's what it looked like if you cut yourself. It has stopped. She also noted that it was more like a nose bleed coming out of her mouth. She gargled with warm salted water. Treatment of the events blood in sputum, nose bleed and tooth disorder included using a mouthwash medication to make gargles and also warm salt water. The clinical outcomes of achey and tired for two days were reported as unknown. The clinical outcomes of blood in sputum, nose bleed and tooth disorder were reported as recovered on an unspecified date in Jan2021.
75 2021-03-02 chest pain, atrial fibrillation, palpitations AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarifie... Read more
AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.
75 2021-03-02 oxygen saturation decreased has lupus and a couple days ago, she started having inflammation pain; has lupus and a couple days a... Read more
has lupus and a couple days ago, she started having inflammation pain; has lupus and a couple days ago, she started having inflammation pain; Fever; Achy; Pleuritic pain; Shortness of breath; O2 level was a little lower it was in the low 90's and she usually runs 96 to 97; This is a spontaneous report from a contactable consumer reporting for herself. A 75-years-old female patient received the second dose of bnt162b2 (BNT162B2)vaccine , intramuscular in the right arm on 08Feb2021 15:30 at single dose for covid-19 immunisation . Medical history included systemic lupus erythematosus , asthma, thyroidectomy . The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on 18Jan2021. The patient has lupus and a couple days ago, she started having inflammation pain on 14Feb2021 with outcome of unknown, O2 level was a little lower it was in the low 90's and she usually runs 96 to 97 on Feb2021 with outcome of unknown , fever on 09Feb2021 with outcome of unknown , achy on 09Feb2021 with outcome of unknown , pleuritic pain on Feb2021 with outcome of recovering , shortness of breath on Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included oxygen saturation: low 90's. The second day, she had a little bit of a fever and was achy. She has lupus and a couple days ago, she started having inflammation pain. It has progressed and went to pleurisy pain. She has really been down for the count. She has had problems breathing with the pleurisy pain, but she has had no fever. She has had a little shortness of breath. She has a pusle oximetry and her O2 level was a little lower, it was in the low 90's and she usually runs 96 to 97.The patient has taken Tylenol and the pleurisy pain is better. She can breathe without pain. The patient is wondering if the vaccine causes problems or after affects for more than a week sometimes or if this is just plain lupus causing issues. Information on the lot/batch number has been requested.
75 2021-03-02 palpitations heart racing shortly after vaccination
75 2021-03-02 heart rate increased it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appeti... Read more
it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appetite; Nausea; breathing problems; mild fever; Muscle ache; Joint ache; Rapid heart rate up to 130; Itchy skin; roof of mouth itching; eyes were also really sore; This is a spontaneous report from a contactable Other HCP (patient). A 75-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing asthma initially diagnosed at 21 years old, ongoing arthritis diagnosed 10-15 years before but she thinks she had it since she was 35, multiple joint replacements, past pneumonia. The patient's concomitant medications were not reported. The patient previously received methotrexate 25mg a week orally for arthritis but she quit taking it about 3 months before in preparation of getting the vaccine. The patient previously received the first dose of bnt162b2 on unspecified date (lot EL8982) at single dose for COVID-19 immunisation in the right arm. The patient experienced mild fever on 12Feb2021 with outcome of recovered on 14Feb2021, roof of mouth itching on 11Feb2021 with outcome of recovered on 11Feb2021, muscle ache on 12Feb2021 with outcome of recovered on 12Feb2021, joint ache on 12Feb2021 with outcome of recovering, breathing problems on 12Feb2021 with outcome of recovering, rapid heart rate up to 130 on 12Feb2021 with outcome of recovering, itchy skin on 11Feb2021 with outcome of recovered on 11Feb2021, it showed a "crp value" of 11.5 which is usually below 0.29 on 15Feb2021 with outcome of unknown, nausea on 12Feb2021 with outcome of recovered on 13Feb2021, loss of appetite on 13Feb2021 with outcome of recovered on 13Feb2021, eyes were also really sore on 11Feb2021 with outcome of recovered on 15Feb2021. An EKG performed on 15Feb2021 as pending results. The event of breathing problems was serious due to disability. The events mild fever, roof of mouth itching, muscle ache, joint ache, rapid heart rate up to 130 and itchy skin were medically significant. The patient reported that initially, the roof of her mouth started itching. It literally happened as soon as she had the vaccine. She took a Benadryl. She didn't have a skin irruption, but did have itchy skin. The next day, she had a low grade fever. She had muscle and joint aches. She had no rash, but a little nausea. She had breathing problems. She had asthma issues and wheezing after the vaccine. That is how she described her breathing issues. She had a rapid heart rate. It went up to 130. It could of been because of fever, her breathing, or pain. There was a period of days then it resolved. On 15Feb2021, she feels almost human. She had routine arthritis lab drawn on 15Feb2021. They showed a CRP level of 11.5 which shows inflammation. She normally was below 0.29 which was within normal limits. That was an extreme difference. That was a lot of inflammation. The patient had to get her nebulizer out to breathe. She has taken Tylenol a couple of times. Her lab work was essentially normal. The CBC and chemical panel was okay. The patient thoughts the fever was important because she has been immunocompromised for years by Methotrexate. She has had pneumonia before with no fevers. Her eyes were also really sore. They bothered her. She already had to use eye drops. That was 11Feb2021 it was gone on 15Feb2021 but it kind of lasted a few days. Her muscles were better, but her joints still hurt some. But her joints always hurt some. She has had multiple joint replacements. The muscles in her legs were severe Friday and Saturday. Her muscles aren't hurting now, but her joints were but that was kind of normal. Her peak flow was way down on 14Feb2021. It was at 250. She did finally get it up to 350 by using her nebulizer. Her best effort normally is 450. Her peak flow was down quite a bit. She has been having breathing changes for a year. They were not sure what it was about. It could be an acute episode of something. On unknown date (next morning as reported), her pulse was 90-100. Now her heart rate was only elevated with activity. Her heart rate was down in the 70s, but when moving it was in the low 100s. With activity it was still up. It was hanging out in the 70s except exercising. She considers walking across the room exercising. All her other labs were in within normal limits. The patient wanted to know if the inflammatory response was secondary to the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
75 2021-03-03 pulmonary embolism Cellulitis left arm - red and swollen, 2 pulmonary embolism, right tibial blood clot
75 2021-03-03 hypertension, very slow heart rate Following second dose of COVID 19 vaccine patient developed SOB with 4-5 word dyspnea and increased ... Read more
Following second dose of COVID 19 vaccine patient developed SOB with 4-5 word dyspnea and increased work of breathing. Pt. also complained of tingling in bilateral lower extremities. Pt. also noted with hypertension and bradycardia (beta blocker therapy). She was given Zyrtec 10mg po without resolution of symptoms within 30 minutes. Pt. then received IM Epi-Pen. Pt. remained alert and appropriate with on-going SOB when EMS arrived to transport to local ED. Medical response was activated for this event.
75 2021-03-03 chest discomfort SOB, Chest pressure. Evaluated by EMS-Cleared
75 2021-03-03 blood pressure increased dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd fe... Read more
dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd feeling all over, fatigue
75 2021-03-04 chest pain Patient reports a burning sensation in her chest, weakness, and fatigue. States this started Wednes... Read more
Patient reports a burning sensation in her chest, weakness, and fatigue. States this started Wednesday following the vaccine.
75 2021-03-05 heart rate irregular 45 minutes after the injection symptoms started as tingling of lips, then tingling of tongue, then ... Read more
45 minutes after the injection symptoms started as tingling of lips, then tingling of tongue, then my throat felt dry, hard to swallow. I drank fluids thinking that might help. The symptoms got stronger in a few hours when my heart beat was irregular and only 51-57bpm. I laid down and took my blood pressure which was normal and heart beat became normal. Later I could tell my lips and tongue were swollen. I live alone and had no way to get to the hospital so late at night . I called my primary doctor to see if I could be a walk-in and the nurse said to go to the ER immediately. my neighbor brought me. There I was given steroids and Benadryl and monitored for a couple of hours. I am on prednisone for 5 days total and was told to take two Benadryl if symptoms return. I will take it now, because my throat still feels funny.
75 2021-03-06 fainting, fast heart rate Tachycardia. I fainted
75 2021-03-07 hypertension, blood glucose increased Blood pressure high; Blood sugar usually is between 115-130 and now last night it has been 168 and h... Read more
Blood pressure high; Blood sugar usually is between 115-130 and now last night it has been 168 and higher.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231) via an unspecified route of administration in left arm on 21Jan2021 10:30 at single dose for COVID-19 immunisation, amlodipine besilate (manufacturer unknown) oral from an unspecified date and ongoing at 10 mg twice a day for high blood pressure, insulin human (NOVOLIN R) via an unspecified route of administration from an unspecified date and ongoing as needed (U-100, inject 5 units by sliding scale if blood sugar over 150) for diabetes, clonidine oral from an unspecified date and ongoing at 0.2mg daily, via an unspecified route of administration from an unspecified date to an unspecified date at 0.3 mg daily for high blood pressure, hydrazine oral from an unspecified date and ongoing at 200 mg two times a day (2 tablets by mouth in the morning, 2 tablets by mouth in the evening) for high blood pressure. Medical history included ongoing thyroid nodule and her thyroid was okay and her numbers okay for cholesterol, ongoing dialysis, high blood pressure. The patient's concomitant medications were not reported. Since taking the vaccine, the past 4-5 days the patient's blood pressure and blood sugar had been out of whack. The patient had said something to her doctors about this because something was going on because she has been having to use her sliding scale insulin when her sugar got to 150. Usually was under 150 and if she went over that she took a shot of insulin if necessary. She had used insulin human more in the past few days at least once a day. The patient had not had to use insulin human in past, it was still almost full. Again, the patient had taken more shots since this Covid than she had had in a whole year. The patient just talked to the kidney doctor and then she was going to the Endocrinologist on Thursday for the first time. They maintain her blood sugar records at dialysis center. Blood sugar usually was between 115-130 and now last night it had been 168 and higher. The patient knew something was not right and it had not been like that for so long. The patient spoke with the dialysis doctor on 01Feb2021 about her blood pressure and they adjusted her medication. The patient clarified her blood pressure had also been high. When she left 01Feb2021 her blood pressure was 168/79 and later that day was 189/70 which was very unusual for her. The other day when she went home it was 136/78. It was the Clonidine that was adjusted was taking 0.1mg, 2 tablets a day to now taking 3 a day. The action taken in response to the events for amlodipine besilate, insulin human, clonidine, hydrazine was dose not changed. The outcome of events was not recovered. Pfizer is a marketing authorization holder of [Amlodipine Besilate] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Amlodipine Besilate] has submitted the same report to the regulatory authorities.
75 2021-03-07 palpitations I had no side effects up until 3 days later, 02/25/2021, during lunch my heart started racing and po... Read more
I had no side effects up until 3 days later, 02/25/2021, during lunch my heart started racing and pounding and I could not catch my breath. I tried to relax and eat and I felt like I had indigestion coming on. Then I started feeling very mild tightness in my throat. Later I had mild ringing in my ears. i had intense anxiety from the time my heart started pounding. ALL of these symptoms lasted for 3 days and It only happened when I ate food. I tossed and turned all night and my body was very uncomfortable and I was still extremely anxious. I started getting better after 3 days and took about 9 days to finally start feeling right. Doctor gave me an EKG and said it was fine but sent me to a cardiologist. I had another EKG, ECHO, 24 hour Monitor with a Holter, and a stress test. results pending. PLEASE NOTE: I am allergic to Cipro and I found that there is a common ingredient in Cipro and the Covid vaccines: Polyethylene Glycol Maybe there's a correlation?
75 2021-03-09 nosebleed On Friday morning, she had pain and bleeding in right nostrils. Had two huge canker sores in mouth. ... Read more
On Friday morning, she had pain and bleeding in right nostrils. Had two huge canker sores in mouth. Left side of lip was swollen, crunchy and bloody. Still having pain in nostril.
75 2021-03-09 heart rate increased my heart beating fast/the pulse reading 170; This is a spontaneous report from a contactable consume... Read more
my heart beating fast/the pulse reading 170; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, Lot number unknown), via an unspecified route of administration in the right arm on 05Feb2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included arthritis and Penicillin Allergies. The patient was not pregnant. The patient did not receive other vaccine on the same date and in four weeks. The patient's concomitant medications were unspecified other medication in two weeks. Yesterday (05Feb2021) the patient received her first dose of Covid-19 vaccine at (vaccine facility name) around 3PM. They had everyone wait in the observation room for 15 minutes after the shot. She was fine during that time. In the evening around 8PM she noticed that her heart beating fast. A home use Oximeter showed the pulse reading 170 around 10PM. An hour later it went down to 105. This morning it came down to 84. She slept well last night. Her next appointment for the second dose is on 26Feb2021. Ae resulted in [None of the above]. The patient did not receive treatment for adverse event. The patient did not have COVID prior vaccination. The patient did not have COVID tested post vaccination. This event was non-serious and did not result in death and cause/prolong hospitalization, was not life threatening, Disabling/Incapacitating, Congenital anomaly/birth defect. Facility type Vaccine was Hospital. The outcome of the event was recovered on 06Feb2021. Information on the lot/batch number has been requested.
75 2021-03-11 pulmonary embolism, chest pain Chest pain DOE (dyspnea on exertion) Pneumonia of both lungs due to infectious organism, unspecified... Read more
Chest pain DOE (dyspnea on exertion) Pneumonia of both lungs due to infectious organism, unspecified part of lung Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present Death
75 2021-03-11 loss of consciousness Driving home, I felt like my eyes were getting harder to keep open and I blacked out. Woke up due t... Read more
Driving home, I felt like my eyes were getting harder to keep open and I blacked out. Woke up due to my car veering into on coming traffic, hitting two cars.
75 2021-03-11 fainting, lightheadedness On 3/7 the patient presented to the ED after having 3 episodes of presyncopal staring events in the ... Read more
On 3/7 the patient presented to the ED after having 3 episodes of presyncopal staring events in the past week, and reports having them over the past year and a half. Reason for admission: syncope and collapse. Per, EUA all hospitalizations must be report after recently receiving a vaccine. This patient has had a history of syncope and this hospitalization does not seem to be related to the vaccine.
75 2021-03-11 chest discomfort When I was outside leaving the facility, I noticed a tight knot in my chest.Less than a half an hour... Read more
When I was outside leaving the facility, I noticed a tight knot in my chest.Less than a half an hour later,I had pulled over in the park and was trying to fix myself. Soon I realized breathing was not helping. It didn't seem to work. Exercise did not help. I started getting worse. I had difficulty getting back to my car I was fatigued my vision was getting blurry.My thinking was not sure. I couldn't figure out how to get my seat down in my car. Finally I got it down enough so I could recline. Then I decided to try to use my I watch pull up my Hart app.I measured over 155 bpm. I noticed that I was feeling better as my heart rate decreased to 141 bpm. I decided to drive home and left my car seat reclined. When I got h I stayed laying down in my bed for two hours because when I tried to get up I was way too dizzy. I've been unable to reach my primary care doctor when I got home. I left a voice messages. I called my sisters to tell them what was wrong and while on the phone St. Luke's was trying to call me and then my sister said she had to hang up because St. Luke's was trying to call her. I got up when I heard a knock on the door. It was the police. St. Luke's had called the police. My heart rate was normal before I got up Almost 3 hours after my shot. I spent the rest of the day and the next morning trying to find out what happened to me. I have spent days trying to get warnings about what to look out for. Finally I found this on your website as well as the handout I should've had before the vaccine because I would've known what was happening to me and what to do.
75 2021-03-12 blood pressure increased, blood pressure decreased, palpitations 2:00 p.m. day of injection - suddenly very tired; 6:00 p.m. heart pounding; 7:00 p.m. blood pressure... Read more
2:00 p.m. day of injection - suddenly very tired; 6:00 p.m. heart pounding; 7:00 p.m. blood pressure spiked to 181/93 (headache); 9:00 p.m. blood pressure dropped to 112/53 - then chills, muscle/joint pain, felt very unwell 3/7/2021 - small red itchy spot appeared on belly 3/9/2021 - full blown itchy red rash on belly
75 2021-03-12 chest pain After 15 minutes of receiving the shot the patient was preparing to leave when she developed a sharp... Read more
After 15 minutes of receiving the shot the patient was preparing to leave when she developed a sharp pain that began in her upper left back then radiated to her mid chest. Chest pain lasted about 2 minutes before dissipating. Bp 133/71 heart rate in the 70's and O2 sat 97%
75 2021-03-14 palpitations I experienced prickly heat to my face and neck, red splotches on my face and a racing heartbeat last... Read more
I experienced prickly heat to my face and neck, red splotches on my face and a racing heartbeat lasting only about ten minutes. It began to subside and I took Benadryl 25mg about fifteen minutes later with no additional symptoms. Nothing else was different about my morning routine but felt this was worth reporting since it may have been from the vaccine about 19 hours previously. It felt severe at the time but began resolving before I attempted to contact medical personnel.
75 2021-03-18 cardiac arrest Patient experienced respiratory failure and cardiac arrest on day of vaccination. Received CPR, targ... Read more
Patient experienced respiratory failure and cardiac arrest on day of vaccination. Received CPR, targeted temperature management
75 2021-03-18 heart rate increased rapid heart beat
75 2021-03-20 chest pain Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen ... Read more
Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen lymph nodes that hurts like crazy; Swollen lymph nodes that hurts like crazy; arm got sore; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31May2021), via an unspecified route of administration on 03Feb2021 (at the age of 75 years) as single dose for covid-19 immunisation; potassium chloride (KLOR-CON M10), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included ongoing type 2 diabetes and ongoing high blood pressure. Concomitant medications included metformin; atorvastatin; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Consumer stated she got her Covid inoculation last Wednesday and in Feb2021, she was experiencing symptoms, adverse reactions. She had injection site pain still, muscle pain, her lungs are fine but when she breathe her front and back of her chest hurts. She had chills. She did not think she had a fever but she was definitely feeling unwell and the most difficult thing was swollen lymph nodes that hurts like crazy. She cannot read this too well. Lot was 2CI or EI EL3302 expires 31May2021. Her arm got sore but today she really started may be yesterday experiencing this muscle pain and the lymph stuff going on. Consumer stated she had no treatment. The last time her doctor gave her this new medication because she had run out of her potassium. It was called Klor-con M10 tablet. For lab work, consumer stated she did not know but right before she went there they took some blood and when the doctor gave her the Klor thing, she had a violent reaction to it. she threw up and had a lot of diarrhea and she have not taken it since. Results of lab work was unknown. The action taken in response to the events for potassium chloride was unknown. Outcome of events was unknown. Information about lot/batch number has been requested.
75 2021-03-21 low blood oxigenation Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chil... Read more
Admitted on 2/17/2021 with acute respiratory failure with marked hypoxia. Noted to have fever & chills, weakness and acute confusion ~ 3 days prior to admission. Placed on NIPPV, steroids, convalescent plasma and antibiotics. Patient died 2/24/2021
75 2021-03-21 heart flutter, atrial fibrillation, pulmonary embolism Patient presented to clinic on 2/28 with fluttering in chest. EKG showed potential atrial fibrillati... Read more
Patient presented to clinic on 2/28 with fluttering in chest. EKG showed potential atrial fibrillation. Patient subsequently admitted to hospital on 3/2 for new onset a fib and pulmonary embolism and VTE in right leg and was inpatient until 3/6/21.
75 2021-03-23 fast heart rate Approx. 12 hours after receiving a second Covid shot my wife experienced difficulty swallowing, the ... Read more
Approx. 12 hours after receiving a second Covid shot my wife experienced difficulty swallowing, the sensation that her throat was closing and a very rapid heartbeat.
75 2021-03-24 inflammation of the pericardium, chest pain She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, an... Read more
She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better. About 12 hours later she had a headache and took some Aleve. She woke up the next morning with a severe headache and chest pain that was excruciating. Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis. They sent her home with steroids and Colchicine. They did not want to put her on NSAIDS due to possible ulcers. She all the COVID symptoms, and had severe pain still. Her daughter 3 weeks later took her to the cardiologist. She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine. She was then sent to the ER again, and went there twice. He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues. They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter. She is now back in sinus rhythm. She was advised not to get the 2nd vaccine due to the reactions from the first one. She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.
75 2021-03-25 blood pressure increased Swelling at injection site. 183/99, HR 77, R. 70, 98.6. Pt. observed with swelling at injection si... Read more
Swelling at injection site. 183/99, HR 77, R. 70, 98.6. Pt. observed with swelling at injection site. Elevated BP has history. Transported to a Hospital for further evaluation.
75 2021-03-28 cardiac arrest Cardiac arrest witnessed by family. Pt became SOB at home and became unresponsive. CPR was started b... Read more
Cardiac arrest witnessed by family. Pt became SOB at home and became unresponsive. CPR was started by family. Pt was in asystole, intubated, given two rounds of epinephrine in the field. Pt was on autopulse and ROSC was achieved around 0125. Pt was seen at ER and was transferred to Hospital.
75 2021-03-29 blood glucose increased My sugar has spiked; This is a spontaneous report from a contactable consumer (patient herself). A 7... Read more
My sugar has spiked; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6201), via an unspecified route of administration administered in arm right on 22Jan2021 (at the age of 75-years-old) as single dose for covid-19 immunisation. Medical history included diabetes for years, blood pressure/high blood pressure for years, cholesterol, and Afib (atrial fibrillation). Concomitant medications included amlodipine taken for blood pressure; losartan potassium taken for blood pressure; carvedilol (CARVIDIL) taken for high blood pressure (unsure how long she has been taking it); isosorbide taken for blood pressure; furosemide (20 mg) taken for water pill; rosuvastatin calcium (CRESTOR) taken for cholesterol; spironolactone taken for blood pressure; eicosapentaenoic acid ethyl ester (VASCEPA) taken for fish oil; apixaban (ELIQUIS) taken for Afib; insulin glargine (LANTUS) taken for diabetes; semaglutide (OZEMPIC) taken for diabetes. Consumer stated, she had the COVID Vaccine of Pfizer on the 22nd, 2 days ago and she had noticed her sugar has spiked in Jan2021. It was this possibly from the shot. Originally called to report that her blood sugars were spiking after taking the Pfizer Covid vaccine. It did not have any new events to report. Patient stated she (social media withheld) it and read that the Pfizer shot can trigger increased blood sugar, wanted to know if this was true. Patient stated she had been on all of her concomitant medications for a while. Treatment: Consumer stated she was taking semaglutide (OZEMPIC), 0.5 mg, once a week and she thought it was insulin glargine (LANTUS), '8 mg' once a day.
75 2021-03-30 cerebrovascular accident Patient recieved first dose of COVID vaccine and left the clinic at 12:20. By 1300 patient was very... Read more
Patient recieved first dose of COVID vaccine and left the clinic at 12:20. By 1300 patient was very confused and unable to answer questions. Patient was taken to the hospital and was diagnosed with a Non-Traumatic Intracranial Hemorrhage
75 2021-03-30 excessive bleeding bleeding; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-ol... Read more
bleeding; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 25Feb2021 at 11:00 at a single dose for COVID-19 immunisation. Medical history included anxiety, cholesterol was getting high, blood pressure is a little high, depression, asthma, arthritis and bowel problem. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) taken for depression from 1999 and ongoing; ongoing alprazolam (XANAX) taken for anxiety; ongoing aripiprazole (ABILIFY) taken for anxiety and depression; ongoing mirtazapine; ongoing diclofenac taken for arthritis; ongoing atorvastatin calcium (LIPITOR) taken for Cholesterol was getting high; ongoing enalapril taken since blood pressure is a little high at times; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma. On 28Feb2021, without any changes to her diet; she started having diarrhea and had it for 7 days. Inquiring as to whether it was a possible side effect from vaccine. Stated diarrhea lasted until the morning of 06Mar2021 and ended with bleeding on an unspecified date. Stated she has recovered and was back to normal. She did not have any labs, testing or treatments but was seeing a new Gastroenterologist on 20Apr2021 due to this event. She doesn't know what the bowel problem was; that this happened sometimes but this was the first time ended in bleeding. Had colonoscopy 30Nov2020 and was fine, no polyps. The facility where the vaccine was administered was in a Local (pharmacy name withheld) Pharmacy. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office or Emergency Room. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event diarrhea was recovered on 06Mar2021 and unknown for the other event. Information on the lot/batch number has been requested.
75 2021-04-04 loss of consciousness, pulmonary embolism Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised ... Read more
Patient called PCP office 3/5 w/ c/o N/V/D, weakness and lightheaded when she stood up. Was advised to hold blood pressure medication. On 3/8, was feeling much worse and called 911. Upon arrival (8:55), patient A&O x 4 with poor oxygen saturation (O2: 88%). Given nebulized albuterol/ipratropium. BG: 247mg/dl. Patient has episode of dry heaving after which she vagaled down with HR in the 40s. Recovered on her own. Once the nebulizer treatment ended, she was place on nasal O2 at 3 liters/minutes. Given 4mg ondansetron. Lost consciousness and respirations became agonal. Pt was bagged via BVM and noted to be in PEA. CPR initiated, including intubation. Given 1mg epinephrine. NSR obtained after two rounds of CPR. Pt arrested again shortly after arrival to ED. ACLS initiated once more. Patient expired at 10:40 am.
75 2021-04-06 chest discomfort difficulty breathing when laying down; Constant "fluttering" in chest for 2 - 3 hours; difficulty ta... Read more
difficulty breathing when laying down; Constant "fluttering" in chest for 2 - 3 hours; difficulty taking medication in large capsules; This is a spontaneous report received from a contactable consumer (patient). This 75-year-old female patient, did not Pregnant at the time of vaccination, received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot EL9269) on 06FEB2021 at single dose on Right arm for COVID-19 immunization. Medical history included ARVD, Breast Cancer, Carcinoid Syndrome, Autoimmune Problems, Asthma. Allergies included Several meds and seasonal respiratory. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. Concomitant medications were not reported. Event started on 06Feb2021 07:45 PM, several hours after vaccination, constant "fluttering" in chest for 2 - 3 hours, difficulty breathing when laying down, difficulty taking medication in large capsules. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was Recovered. Information on Lot/Batch number was available. Additional information has been requested.
75 2021-04-06 atrial fibrillation, heart rate increased patient experienced rapid heartbeat and afib/seems more than a coincidence that she experienced the ... Read more
patient experienced rapid heartbeat and afib/seems more than a coincidence that she experienced the heart issues after the vaccines since she had been doing very well for the past year; patient experienced rapid heartbeat and afib; patient experienced rapid heartbeat and afib; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm on 27Feb2021 11:30 (Batch/Lot Number: EN6202) as SINGLE DOSE, via an unspecified route of administration, administered left arm on 20Mar2021 12:30 (Batch/Lot Number: EL9267) as SINGLE DOSE for covid-19 immunization. Medical history included AFib (Atrial fibrillation), penicillin allergy, arthritis, hypertension and MAZE procedure; the patient had MAZE procedure to cure A-fib but after 3 yrs it returned. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included dofetilide (TIKOSYN) taken for AFib, start and stop date were not reported. On 27Feb2021, patient had 2 short - less than a minute - bursts of rapid heartbeat. On 07Mar2021, the patient experienced rapid heartbeat and a-fib for 2 days. On 15Mar2021, patient experienced another 2 days of rapid heartbeat and a-fib. The patient received the second shot on 20Mar2021 and 25 hrs later on 21Mar2021, patient experienced rapid heartbeat and afib again for about 15 hrs. The patient stated she's someone on RX for A-fib. that it seems more than a coincidence that she experienced the heart issues after the vaccines since she had been doing very well for the past year. The outcome of events was unknown. Follow-up attempts are completed. The information on the batch number has already been obtained.
75 2021-04-17 excessive bleeding Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't mo... Read more
Exacerbation of COPD/having trouble breathing; extremely tired, couldn't get out of bed, couldn't move/tiredness; weakness; bleeding; Test: Iron; Result: Critically low; red blood cell was below 5; administered at the left upper forearm; This is a spontaneous report from a contactable nurse (patient) via Pfizer. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left upper forearm on 01Mar2021 at the age of 75-years-old as single dose for COVID-19 immunization. The vaccine was administered to the patient at a pharmacy (in a grocery store). The patient had no prior vaccinations (within 4 weeks). The patient's medical history included retired (retired registered nurse), ongoing depression (has had this condition for probably 20 years), ongoing lung cancer (has had this condition for probably 3 years), ongoing bipolar (has had this condition for about 4 years), ongoing emphysema (has been severe for about 4 or 5 years), and ongoing chronic obstructive pulmonary disease (COPD) (has been severe for about 4 or 5 years). Concomitant medications included duloxetine taken for depression from an unspecified start date and ongoing (been taking this probably for 15 years); and arformoterol tartrate (BROVANA) (started taking this probably 5 years ago), budesonide (started taking this probably 5 years ago), tiotropium bromide (SPIRIVA) (has been taking this for probably about 4-5 years), oxygen (has been using this full time for 3 years), and Trilogy machine (she sleeps with this, it is an invasive intubation. She puts a big mask on and it pumps air in, pulls air out, letting her lungs rest. Her oxygen hooks up to it), all taken for emphysema and COPD from an unspecified start date and ongoing. The patient reported that she received the vaccine on 01Mar2021 and sometime in Apr2021 around Easter, she went to the hospital for COPD exacerbation, tiredness and weakness. The patient required a visit to the emergency room due to the events and reported that she went by ambulance to the hospital. The patient stated that she has these events often and it has nothing to do with the COVID vaccine. She went to the hospital with exacerbation of COPD and missed her date to get her last shot. She wanted to know whether she can get the 2nd dose of the vaccine with her experience after the 1st dose. The patient reported that she now weighs 177 after she has been pumped full of cortisone. The patient reported that her lung doctor was really the one that manages her medical. The patient reported that she thinks she came home from the hospital the day before Easter and she was in the hospital for 5 days (in Apr2021). She was sick before that, at home, and she finally had to call # to come and get her. She believes she had to call # the 5th day before Easter, but she was not positive. When asked to clarify what she meant by sick, the patient explained she was extremely tired, she couldn't get out of bed and couldn't move. She was having trouble breathing. She was on oxygen 24/7 and sleeps with a trilogy machine so she was having a lot of trouble, it was awful. She said she then found out at the hospital her red blood cell was below 5 and her iron was critically low. They had to give her 2 units of blood and an infusion. Then she went back yesterday and got another infusion and she has to go back next week for another infusion. The patient confirmed that she was hospitalized for COPD. She then stated she didn't know the exact date of when she was discharged from the hospital, but she was thinking it was the day she was scheduled for her second shot. She then clarified she came home Easter. The patient reported that she can't do much without having to sit down, catch her breath, and rest a little bit. She was improving but not as fast as she'd like to. While reading the vaccine record card, the patient stated "my eyes aren't as good as they used to be". Her pulmonologist stated she was going to die if she doesn't take the vaccine. If she catches COVID she was not going to make it, so her pulmonologist thinks her chances are better with the vaccine than without it. The patient said she goes all the time to the hospital; therefore, she doesn't think the events were related to the vaccine. She had been sick several times. They can't do anything about the bleeding, they can't go in to do anything because of her lungs, her lungs were so bad. No further details were provided regarding the bleeding she was speaking of. The patient reported that duloxetine doesn't come as 90 mg so she takes a 30 mg and 60 mg tablet; she mixes the Brovana and Budesoind and takes them at the same time, twice a day. She was given an albuterol solution, 0.5mg PRN (as needed), for her emphysema/COPD. She says she just started taking this from her last hospital stay. The patient reported that she did not remember her iron count, just that it was critically low. She did remember asking the nurse what could happen, and the nurse said a lot of things such as infection. She confirmed tests were done in regards to the lung cancer. Her lungs were too critical for any kind of invasive tests. It was reported that the events Exacerbation of COPD and "extremely tired, couldn't get out of bed, couldn't move" were assessed by the patient as unrelated to BNT162B2. The outcome of the events "Exacerbation of COPD/having trouble breathing" and " extremely tired, couldn't get out of bed, couldn't move/tiredness" was recovering, while the outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, the reported events Chronic Obstructive Pulmonary Disease, Fatigue, Asthenia, Blood iron decreased, Red blood cell count decreased and Asthenia are assessed as intercurrent medical conditions and unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
75 2021-04-17 atrial fibrillation Extreme pain right arm, leg and upper back. Emergency room ordered CT scans and MRI's. That resulte... Read more
Extreme pain right arm, leg and upper back. Emergency room ordered CT scans and MRI's. That resulted in cervical C3 thru C7 epidural mass. Hemilaminectomy for evacuation of hematoma on 3-17-2021. C5-C6 discectomy anterior cervical w/ fusion 3-18-2021. Resulting complications were unexplained atrial fibrillation 3-21-2021, Ongoing rehab appointments for right arm and leg numbness.
75 2021-04-23 chest discomfort Wheezing; cough; Feverish feeling in her chest; This is a spontaneous report received from a contact... Read more
Wheezing; cough; Feverish feeling in her chest; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EN5318) via an unspecified route of administration in the left arm on 06Feb2021 at 16:15 (at the age of 75-year-old) as a single dose for COVID-19 immunization in Pharmacy/drug store. Medical history included fibromyalgia, arthritis, sinus problems, acid reflux, high blood pressure and seasonal allergies. Concomitant medications included Omeprazole treated for acid reflux, Pregabalin and Tramadol for fibromyalgia and arthritis, lisinopril for high blood pressure, colecalciferol (VITAMIN D), Fish oil, loratadine (CLARITINE) for seasonal allergies and Hair Skin & Nails.The patient did not receive any other vaccines within four weeks prior to the vaccination and did not experienced any adverse reactions prior vaccination. Patient felt fine until 11Feb2021 and had been experiencing a lot of coughing and wheezing but had no fever. Patient was taking over the counter cough medicine to treat the reaction. Patient enquired if this reaction can happen 4-5 days after receiving the vaccine. On an unspecified date in Feb2021, the patient experienced feverish feeling in her chest. The outcome for the events coughing and wheezing was recovering and feverish feeling in her chest was not recovered.
75 2021-04-24 blood clot, nosebleed infection; Abnormal nose bleed with blood cloths the first day; Abnormal nose bleed with blood cloth... Read more
infection; Abnormal nose bleed with blood cloths the first day; Abnormal nose bleed with blood cloths the first day/6 more nose bleed that it was taking me to control up to 30 min; This is a spontaneous report from a contactable other HCP (patient). A 75-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), via an unspecified route of administration on 15Mar2021 10:45 (at 75 years old, not pregnant), single dose for covid-19 immunisation. Medical history included Type II diabetes, Hypertension, GERD and hypercholesterilymia, sulfa allergy, all from an unknown date. Concomitant medications included verapamil; rosuvastatin calcium (CRESTOR); metformin; omeprazole, unspecified blood thinners. The patient previously took tetracycline for known allergies: Tethracycline. Patient experienced abnormal nose bleed with blood cloths the first day (reported as 30Mar2021 0130). Five days later in two days had 6 more nose bleed that it was taking me to control up to 30 min. She went to ER in the morning and had a CBC having results normal with normal levels of platelets. She was referred to PCP. She saw a NP next day and gave me referral to ENT specialist. Using an scope could not find anything and ordered to have CT Scan. Results show negative for polips, tumors and show only a shadow by eye socket which MD believe it was an infection that was leading to the bleed. Prescribe a very small amount of Amoxicilline 125 mg, twice a day for 7 days plus a saline gel. Patient had the last nose bleed at midnight. For 3 days did not have any bleeding until today, at 10:15 am, with heavy bleeding which took me 15 min. to control. She has no history of nose bleed, taking blood thinners, no head traumas either. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the event infection was unknown, other events was not recovered.; Sender's Comments: Information provided was so limited to prevent a meaningful and definite medical assessment for the events. A causal relationship cannot be completely excluded for BNT162B2 injection and development of Thrombosis and Epistaxis, only based on a plausible chronological sequence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
75 2021-05-05 lightheadedness FEELING LIGHTHEADED WHEN SHE STANDS. REPORTS NEAR SYNCOPE UPON STANDING AND GUIDED HERSELF DOWN WHIL... Read more
FEELING LIGHTHEADED WHEN SHE STANDS. REPORTS NEAR SYNCOPE UPON STANDING AND GUIDED HERSELF DOWN WHILE HOLDING A PLATE THAT DID NOT BREAK. REPORTS SLIGHT RIGHT SIDED HEADACHE DESCIRBED AS ELECTRICTY ONLY. NO CONFUSION. NO SPEECH CHANGES. WAS READING WSJ OUTLOUD TO DETERMINE. I ADVISED HER TO GO TO THE NEAREST EMERGENCY ROOM FOR EVALUATION AS I COULD NOT ATTRIBUTE HER SYMPTOMS TO VACCINE ADR. RESTING IN BED TO HELP ALEVIATE SYMPTOMS. NO MEDICATIONS. 5/2-Called the home and there was no answer, 2nd attempt. Message was left to call the Covid hotline for further follow up.
75 2021-05-07 heart attack having a heart attack; couldn't breath; lungs were filled-up with fluid; felt like a pin cushion; Th... Read more
having a heart attack; couldn't breath; lungs were filled-up with fluid; felt like a pin cushion; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN9581), via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included breast cancer/her breast cancer had came back in the same place from 2006, both breasts removed on 2006. Concomitant medication included palbociclib (IBRANCE) taken for breast cancer female from 24Jun2020 to 04Feb2021 then from 01Apr2021 and ongoing. The patient previously received the first dose of bnt162b2 (lot number: EL3248) on 17Jan2021 for COVID-19 immunization and experienced acute bronchitis. On 14Feb2021, the patient was taken by an ambulance and was hospitalized because she couldn't breath, they thought she was having a heart attack, her lungs were filled-up with fluid. The doctors had her on oxygen while she was in the hospital, and did heart and lung tests on her on an unspecified date in 2021. While in the hospital, the patient felt like a pin cushion on an unspecified date. The patient left the hospital on 17Feb2021. The patient was tested for COVID-19 three times on unspecified dates all with negative results. the patient was hospitalized again on 25Feb2021 to 01Mar2021 for reasons not reported. The outcome of the events she couldn't breath, thought she was having a heart attack, her lungs were filled-up with fluid was recovered on 17Feb2021, while for the event felt like a pin cushion was unknown.
75 2021-05-10 pulmonary embolism I26.99 - Pulmonary embolism
75 2021-05-10 blood clot, deep vein blood clot On 3/23/21 pt had SOB so went to went to the Hospital ER. She had lab work, CT, Chest Xray, ECG 12 ... Read more
On 3/23/21 pt had SOB so went to went to the Hospital ER. She had lab work, CT, Chest Xray, ECG 12 lead. DX is pneumonia of right lower lobe of the lung. She was given Augmentin and released after 7 hours and told to FU w/ PCP. On 3/31/21 pt went to see her PCP due to having SOB. She was given a Covid Test which was negative. She was sent home and told to breath deeply and hopefully this symptom would go away. On 4/18/21 she went back to the Hospital ER for SOB. Pt was admitted with acute DVT and other blood clots as well as pleural effusion of the right lung. They did US on legs and Chest X-Rays. They found fluid around her right lung which they drained. She was prescribed Eliquis. Pt was discharged on 4/21/2021 and was told to FU w/ PCP. On 4/24/21 pt went back to the Hospital ER, because she had a bruising/blood clots in the groin area. She had 3 blood clots on the left side and one on the right side. They told her the bruising was from the Eliquis and they did a US. She was told she had the same blood clots that she had during her hospital stay and they were right where they were before. She was discharged. On 4/29/2021 she went back to her PCP due to SOB. She told her PCP about the DVT that was bothering her. She was sent to another Hospital. She had a stat Chest X-Ray- results were that her lungs were stable with inflammation around the right lung. She was told to FU w/ PCP in July 2021 and go back to ER if she had another episode w/ SOB.